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Compounding

Compounding is the financial process whereby returns on an investment, such as interest or capital gains, are reinvested to generate additional returns, resulting in exponential growth over time rather than linear accumulation.^[1]^[2] This mechanism, often termed "interest on interest," applies to savings accounts, bonds, stocks, and other assets, where the principal increases periodically based on the compounded rate.^[3]^[4] The mathematical foundation involves the formula A = P(1 + \frac{r}{n})^{nt}, where A is the amount after compounding, P is the principal, r is the annual interest rate, n is the number of compounding periods per year, and t is time in years, illustrating how frequency and duration amplify outcomes. Historically, evidence of compounding traces to ancient Babylon around 2000–1600 BCE, with systematic analysis emerging in medieval Europe, though it faced religious and ethical scrutiny for resembling usury in some traditions.^[5]^[6] Its defining characteristic lies in the empirical reality of time's leverage: modest annual returns of 7% can multiply an initial investment by over 15 times in 30 years, underscoring its role in long-term wealth building and economic systems, as opposed to short-term speculation.^[7]^[8]

Definition and Principles

Core Concept and Distinctions from Manufacturing

Pharmaceutical compounding involves the preparation of customized medications by licensed pharmacists or physicians, through the combination, mixing, or alteration of ingredients to address the unique clinical needs of an individual patient. This practice enables the creation of formulations unavailable from commercial manufacturers, such as adjusted dosages, alternative delivery methods (e.g., from oral to topical), or exclusion of excipients causing allergies or intolerances.^[9]^[10] In contrast to manufacturing, which entails the mass production of standardized drug products under stringent federal oversight—including pre-market approval via clinical trials demonstrating safety, efficacy, and quality control—compounding operates on a small-scale, prescription-driven basis without FDA evaluation of the final compounded product. Manufacturers adhere to current good manufacturing practices (cGMP) ensuring batch uniformity, long-term stability, and scalability for widespread distribution, whereas compounding emphasizes immediate patient-specific adaptation, often using FDA-approved active ingredients but relying on the pharmacist's expertise for formulation.^[11]^[10]^[12] Regulatory distinctions further delineate the two: compounding is principally regulated by state pharmacy boards focusing on professional standards and sterility where applicable, while manufacturing requires FDA compliance with comprehensive inspections, labeling, and adverse event reporting for approved drugs. Compounded preparations lack the same level of pre-use validation, potentially introducing variability in potency or contamination risk, though they fill gaps in commercial availability, such as for pediatric or veterinary dosing.^[11]^[10]^[13]

Types of Compounding

Nonsterile compounding involves the preparation of medications that do not require sterility, such as oral liquids, capsules, creams, ointments, and suppositories, typically for topical, oral, or rectal administration. These preparations are governed by United States Pharmacopeia (USP) General Chapter <795>, which establishes standards for quality, including requirements for facilities, equipment, personnel training, and beyond-use dates (BUDs) to minimize risks like contamination or incorrect dosing.^[14] Nonsterile compounding is categorized into three risk levels based on complexity: simple (e.g., reconstituting powders or mixing premeasured ingredients), moderate (e.g., preparing suspensions or incorporating solids into semisolid bases), and complex (e.g., compounding allergen extracts or liposomal gels), each demanding progressively higher expertise and controls.^[15] Sterile compounding produces preparations intended for parenteral, ophthalmic, or other routes where sterility is essential to prevent infections, including injectables, intravenous solutions, and irrigants. Regulated under USP <797>, effective November 1, 2023, it classifies compounded sterile preparations (CSPs) into three categories by risk of contamination and BUD: Category 1 (low-risk, up to 12 hours at room temperature, compounded in a cleanroom or containment segregated compounding area), Category 2 (medium-risk, up to 4 days refrigerated, requiring ISO-classified cleanrooms), and Category 3 (high-risk, up to 45 days, with advanced sterile starting components and full cleanroom suites).^[16] These standards mandate laminar airflow workstations, environmental monitoring, and garbing to achieve sterility assurance levels comparable to manufacturing. Hazardous sterile compounding, involving drugs like chemotherapy agents, falls under USP <800> for additional containment and personnel protections.^[17] Compounding pharmacies operate under two federal frameworks: Section 503A facilities provide patient-specific preparations without FDA pre-approval, adhering to USP standards and state laws, while Section 503B outsourcing facilities produce larger batches for hospitals, subject to FDA inspection and current good manufacturing practices (cGMP) but exempt from new drug approval for certain uses.^[18] This distinction arose from the 2013 Drug Quality and Security Act following contamination outbreaks, aiming to balance customization with safety.^[19]

Historical Development

Origins and Traditional Practices

Pharmaceutical compounding originated in ancient civilizations, where healers prepared customized medicinal mixtures from natural substances to address specific ailments. The Ebers Papyrus, an Egyptian medical text dating to approximately 1550 BCE, contains over 700 remedies involving the combination of ingredients such as honey, plant extracts, minerals, and animal products into forms like pastes, ointments, and infusions.^[20]^[21] In ancient Greece and Rome, physicians advanced these practices; Claudius Galen (c. 130–200 CE) codified techniques for compounding multiple ingredients into pills, troches, and other dosage forms, emphasizing principles of mixture stability and therapeutic efficacy that influenced pharmacology for centuries.^[22]^[23] During the Islamic Golden Age, compounding evolved with systematic approaches to drug preparation, including distillation and the establishment of the first dedicated pharmacies in Baghdad around the 8th century CE, where pharmacists refined recipes for syrups, electuaries, and aromatic waters using precise measurements.^[24] In medieval Europe, apothecaries emerged as specialized practitioners, forming guilds that regulated compounding standards, enforced quality controls on ingredients, and separated pharmaceutical preparation from medical diagnosis following Emperor Frederick II's 1240 CE edict.^[25]^[26] These guilds promoted ethical practices, such as sourcing pure botanicals and minerals, and disseminating knowledge through early pharmacopoeias like the 1618 London Pharmacopoeia, which standardized compounding formulas for reproducibility.^[27] Traditional compounding practices prior to industrialization relied on extemporaneous preparation tailored to individual prescriptions, dominating pharmacy until the mid-20th century. Pharmacists manually ground ingredients using mortars and pestles, weighed them on balances for accuracy, and incorporated them into vehicles like ointments, tinctures, syrups, or suppositories to accommodate patient-specific factors such as dosage adjustments or flavor masking.^[28]^[29] This hands-on process, often guided by pharmacopoeial standards like the 1820 United States Pharmacopeia compiled by compounding practitioners, ensured medications were freshly made without reliance on mass-produced alternatives, though it demanded rigorous attention to purity and potency to mitigate risks of contamination or inefficacy.^[30]^[31]^[32] In community settings, apothecaries compounded virtually all drugs, blending empirical knowledge with trial-based adjustments for efficacy.^[9]

Transition to Industrial Manufacturing

The transition from artisanal pharmaceutical compounding to industrial manufacturing began in the mid-19th century, as apothecaries increasingly shifted toward wholesale production of standardized drug extracts and alkaloids to meet growing demand and leverage emerging chemical synthesis techniques. Firms such as Merck in Germany initiated industrial-scale alkaloid production as early as 1827, while in the United States, companies like Squibb (founded 1858) and Eli Lilly (1876) expanded from pharmacy roots into large-scale manufacturing of active pharmaceutical ingredients, including morphine, quinine, and biologicals. This shift was driven by advances in organic chemistry and pharmacology, enabling the isolation and purification of potent compounds previously compounded manually, which improved consistency and reduced variability inherent in small-batch pharmacy preparation.^[33]^[34] Regulatory frameworks accelerated the move toward manufacturing by emphasizing purity, labeling, and safety standards that favored mechanized processes over individual compounding. The U.S. Pure Food and Drugs Act of 1906 mandated accurate labeling and prohibited adulterated products, compelling pharmacies to rely on factory-produced drugs that could demonstrate compliance through standardized testing, while the 1902 Biologics Control Act regulated vaccines and sera, further promoting centralized production. By the 1920s, the rise of synthetic drugs like aspirin (commercialized by Bayer in 1899) and insulin (industrially produced by Eli Lilly starting 1923) underscored manufacturing's advantages in scalability and quality assurance, leading to a decline in routine pharmacy compounding as premanufactured proprietary products dominated distribution. World War I disruptions in European supply chains forced U.S. firms like Pfizer to develop domestic synthesis capabilities, solidifying industrial infrastructure.^[33]^[34] The pivotal catalyst came during World War II, when mass production of penicillin—discovered in 1928 but scaled up by Merck, Pfizer, and Squibb from 1943 onward—demonstrated manufacturing's capacity for rapid, large-volume output essential for military and civilian needs, producing billions of doses by war's end. Postwar, the 1938 Food, Drug, and Cosmetic Act required manufacturers to prove drug safety, reinforcing industrial dominance through rigorous validation unattainable in traditional compounding settings. By the 1950s, compounding had largely receded to niche roles, with pharmacists transitioning to dispensing and counseling on factory-made generics and brands, as economic efficiencies and regulatory oversight rendered manual preparation obsolete for most medications. This era marked compounding's evolution from a primary pharmacy function to a specialized practice, supplanted by an industry capable of consistent, verifiable production at scale.^[34]^[35]

Post-20th Century Revival

In the late 20th century, pharmaceutical compounding experienced a resurgence driven by the expansion of home infusion therapy and the limitations of commercial manufacturing in meeting specialized needs. As intravenous nutrition and antibiotic therapies shifted from hospitals to outpatient settings in the 1980s and 1990s, pharmacies adapted by producing sterile compounded preparations in larger volumes, often beyond traditional patient-specific batches, to supply home health agencies and clinics.^[9] This shift was necessitated by the lack of commercially available formulations for pediatric patients, those with allergies to inactive ingredients, or individuals requiring unique dosages, marking a departure from the earlier dominance of mass-produced drugs.^[9] The 1990s saw further diversification, with compounding pharmacies establishing dedicated facilities for bulk production to serve hospitals and address emerging demands in areas like veterinary medicine and hormone replacement therapy. Regulatory clarification under Section 503A of the Food, Drug, and Cosmetic Act, as amended by the FDA Modernization Act of 1997, distinguished traditional compounding—performed on patient-specific prescriptions—from manufacturing, thereby legitimizing and encouraging its growth while exempting it from certain federal requirements if state-licensed and non-advertised as commercial products.^[9]^[36] By the early 2000s, the industry had expanded to include advanced techniques such as flavoring for pediatric suspensions and allergen-free topicals, fueled by technological advancements in equipment like laminar flow hoods and isolators that improved safety and precision.^[37] Into the 21st century, compounding's revival accelerated amid persistent drug shortages, with the U.S. FDA reporting over 250 shortages annually by the mid-2010s, prompting reliance on compounded alternatives for critical medications like chemotherapy agents and electrolytes.^[38] The emphasis on personalized medicine further propelled demand, as compounding enabled adjustments for body weight, organ function, or discontinued formulations, particularly in oncology, pain management, and veterinary care.^[37] However, this growth highlighted quality risks, exemplified by the 2012 outbreak of fungal meningitis linked to contaminated steroid injections from the New England Compounding Center, which infected over 800 patients and caused 64 deaths, leading to stricter standards under USP <797> (first published in 2004 and revised in 2008 and 2019) for sterile compounding and the creation of Section 503B outsourcing facilities in 2013 for larger-scale operations under federal oversight.^[9]^[39] Despite these challenges, compounding pharmacies numbered over 7,500 in the U.S. by 2020, comprising about 7-10% of community pharmacies and playing a key role in niche markets where industrial production proved inefficient or unprofitable.^[9]

Methods and Practices

Equipment, Ingredients, and Techniques

Pharmaceutical compounding requires specialized equipment to ensure accuracy, sterility where applicable, and safety in preparation. For non-sterile compounding, essential tools include Class A prescription balances or electronic analytical balances capable of measuring to 0.1 mg precision, mortars and pestles in various sizes for grinding, spatulas and ointment slabs for mixing semi-solids, geometric diluters for potent substances, and encapsulation machines for filling capsules.^[40] These items must be calibrated regularly and dedicated to compounding to avoid cross-contamination.^[40] Sterile compounding demands more controlled environments and equipment, such as laminar airflow workstations (LAFW) or compounding aseptic containment isolators (CACI) certified to ISO Class 5 standards, autoclaves for sterilization, and environmental monitoring devices for particle counts and microbial air sampling.^[16] Facilities must include buffer areas with positive pressure HEPA-filtered air to maintain ISO Class 7 or better conditions during preparation of compounded sterile preparations (CSPs).^[16] Personal protective equipment (PPE), including gloves, gowns, masks, and eyewear, is mandatory for both types to protect personnel and products.^[41] Ingredients in compounding consist of active pharmaceutical ingredients (APIs) sourced as bulk powders or substances from verified suppliers meeting USP monographs for purity and potency, combined with excipients such as diluents (e.g., lactose, microcrystalline cellulose), binders (e.g., starch), lubricants (e.g., magnesium stearate), preservatives (e.g., parabens), and solvents (e.g., propylene glycol, glycerin).^[42] Excipients must be compendial-grade to ensure compatibility and stability, with compounders required to verify supplier testing for contaminants like heavy metals or microbial limits.^[42] Water used must be purified, often via distillation or reverse osmosis, to prevent introduction of pyrogens or particulates.^[43] Key techniques include trituration, the process of grinding powders in a mortar with a pestle to reduce particle size and achieve uniformity, often followed by geometric dilution for incorporating small amounts of potent APIs into larger volumes of diluents.^[44] Levigation involves triturating solids with a levigating agent like mineral oil or glycerin to form a smooth paste, facilitating even dispersion in creams or ointments.^[45] Other methods encompass spatulation for mixing on a slab, pulverization for breaking down tablets, and encapsulation using manual or automatic fillers to produce uniform capsules.^[46] For sterile processes, aseptic technique mandates single-direction airflow handling, first-air principles to avoid turbulence, and sterilization by filtration or autoclaving for heat-sensitive CSPs.^[16] All techniques prioritize beyond-use dating based on stability data, with documentation of weights, volumes, and calculations to verify final potency.^[40]

Quality Assurance Protocols

Quality assurance protocols in pharmaceutical compounding encompass systematic procedures to verify the identity, strength, quality, and purity of compounded preparations, mitigating risks such as contamination, subpotency, or superpotency. These protocols are primarily guided by United States Pharmacopeia (USP) chapters, including <795> for nonsterile compounding, <797> for sterile compounding, and <1163> for overall quality assurance practices, which emphasize personnel training, environmental controls, and testing to ensure patient safety.^[15]^[16]^[47] Unlike FDA-approved manufactured drugs, compounded products lack pre-market review for safety and efficacy, placing greater reliance on these internal controls enforced by state pharmacy boards and voluntary accreditation bodies.^[18] Personnel qualifications form the foundation of quality assurance, requiring compounders to undergo initial and ongoing training in aseptic techniques, calculations, and equipment use, followed by documented competency assessments at least every 12 months for sterile compounding under USP <797>.^[16] Facilities must maintain controlled environments, such as ISO-classified cleanrooms for sterile preparations with air quality monitoring for viable and nonviable particulates, conducted at least every six months or after significant changes.^[16] Standard operating procedures (SOPs) must detail all processes, from ingredient verification—using certificates of analysis and USP/NF monographs—to labeling and stability assessments, with beyond-use dates assigned based on risk levels (low-, medium-, or high-risk) to limit microbial growth.^[15]^[16] Testing protocols include in-process checks like weight verification and pH measurements, alongside end-product evaluations for sterility (via membrane filtration or direct inoculation for Category 2 sterile compounds), potency (typically 90-110% of label claim via HPLC), and endotoxin limits where applicable.^[16] For nonsterile compounding under USP <795>, quality control testing is required for at least one batch per formulation every six months, assessing microbial limits, potency, and weight variation.^[15] Documentation must be contemporaneous and retained for at least one year beyond the beyond-use date or as required by state law, enabling traceability and audits.^[47] Adverse event reporting to the FDA's MedWatch system is mandatory for serious issues, reinforcing accountability.^[48] Outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act adhere to current good manufacturing practices (CGMP), incorporating additional FDA-inspected elements like process validation and annual product testing, contrasting with traditional 503A pharmacies that follow USP standards without routine federal oversight.^[49] Violations, such as those exposed in the 2012 New England Compounding Center fungal meningitis outbreak involving 64 deaths, have prompted stricter enforcement, including FDA warnings and state interventions to address lapses in sterility assurance.^[18] Comprehensive quality assurance thus integrates preventive measures, rigorous testing, and continuous improvement to approximate the reliability of manufactured pharmaceuticals despite inherent customization variability.^[50]

Applications and Roles

Community and Retail Settings

In community and retail pharmacy settings, compounding primarily involves non-sterile preparations customized for individual patients, such as altered dosages, dye- or preservative-free formulations, or flavored suspensions for pediatric or geriatric use when commercial options are inadequate.^[10] These settings emphasize immediate, patient-specific dispensing, often for topical creams, oral capsules, or troches addressing allergies, swallowing difficulties, or discontinued drug needs.^[9] Approximately 56,000 community-based pharmacies operate in the United States, with around 7,500 specializing in compounding, though up to 94% of independent community pharmacies provide some compounding services.^[51]^[52] Compounded prescriptions represent 1 to 3% of total U.S. prescriptions, a decline from 60% in the 1940s due to industrialized manufacturing, yet remaining essential for niche therapeutic demands.^[10]^[53] Under section 503A of the Federal Food, Drug, and Cosmetic Act, retail compounding pharmacies qualify as traditional compounders, exempt from certain FDA pre-market approval requirements provided preparations are not mass-produced or advertised nationally.^[18] State pharmacy boards oversee licensing and inspections, with federal guidelines mandating adherence to United States Pharmacopeia (USP) Chapter <795> for non-sterile compounding to ensure uniformity, potency, and stability.^[49]^[54] Pharmacists in these environments typically use mortar-and-pestle techniques, electronic balances, and encapsulation machines for small-batch production, prioritizing beyond-use dating based on stability data to minimize degradation risks.^[10] Compounding in retail settings supports medication adherence by enabling palatable or accessible forms, such as sugar-free liquids or compounded hormone therapies, particularly for patients intolerant to excipients in manufactured drugs.^[55] However, operations must navigate limitations like sourcing active pharmaceutical ingredients (APIs) from FDA-registered suppliers to avoid substandard quality, with pharmacies often implementing in-house quality controls including weight verification and pH testing.^[18]^[56]

Hospital and Clinical Environments

In hospital pharmacies, compounding focuses predominantly on sterile preparations, including intravenous admixtures, total parenteral nutrition solutions, and ophthalmologic drops, to address immediate patient-specific needs such as drug shortages, dosage adjustments for pediatrics or neonates, or incompatibilities with commercial products.^[57] These activities occur within controlled cleanrooms or biosafety cabinets to minimize contamination risks, with personnel adhering to garbing protocols like sterile gloves, gowns, and masks.^[43] Unlike retail settings, hospital compounding emphasizes rapid turnaround for inpatients, often integrating with centralized IV admixture services to support high-volume demands in intensive care units and operating rooms.^[58] United States Pharmacopeia (USP) Chapter <797>, revised and enforced as of November 1, 2023, mandates risk-based categories for compounded sterile preparations (CSPs)—low-, medium-, and high-risk—dictating facility design, environmental monitoring, and personnel training to achieve sterility assurance levels exceeding 1 in 1,000,000 non-sterile units.^[59] Hospitals must validate processes through media-fill testing and surface sampling, with beyond-use dates limited to as short as 4 hours for Category 1 CSPs prepared in uncontrolled environments, extending to 30 days under full cleanroom compliance.^[60] The American Society of Health-System Pharmacists (ASHP) guidelines reinforce these by recommending automated compounding devices for high-risk preparations to reduce manual errors, though adoption remains inconsistent; a 2019 survey found only 31% of U.S. hospitals implemented barcode verification or robotics for sterile compounding.^[43]^[61] Clinical environments, such as outpatient clinics or physician offices, engage in limited non-sterile or low-risk compounding, like topical creams or oral suspensions, but face heightened scrutiny due to frequent insanitary conditions identified by the FDA, including inadequate hand hygiene and improper storage leading to microbial growth.^[62] In these settings, compounding is justified only for immediate-use preparations without full USP <797> facilities, with beyond-use dates capped at 1 hour post-preparation to mitigate potency degradation and contamination.^[63] Joint Commission certification programs evaluate hospital compounding for compliance, emphasizing quality assurance through batch documentation and stability testing, yet critics note that resource constraints in smaller clinics often lead to reliance on outsourcing to 503B facilities for complex sterile needs.^[64] Overall, these practices prioritize causal safeguards against microbial ingress and dosage variability, though manual methods persist as a vulnerability, contributing to error rates estimated at 1-9% in unautomated workflows.^[63]

Specialized and Niche Uses

Compounding pharmacies prepare customized formulations for veterinary applications, addressing unique challenges such as animals' inability to swallow commercial tablets or capsules, by creating flavored oral suspensions, transdermal gels, or precisely dosed medications.^[65]^[66] These are essential for companion animals, where standard products may lead to under- or overdosing due to size variations or species-specific needs, and are regulated separately from human drugs to avoid use in food-producing animals.^[67]^[68] The American Veterinary Medical Association emphasizes compounding's role in individualized therapy for conditions like allergies or digestive issues, often using forms like chewable treats or topical applications for easier administration.^[69]^[70] In human medicine, a prominent niche involves compounded bioidentical hormone replacement therapy (cBHT), particularly for menopausal symptoms, where pharmacies mix hormones like estrogen and progesterone to match individual patient profiles, including custom dosages, delivery methods (e.g., creams or troches), or allergen-free bases not available in FDA-approved products.^[71]^[72] Proponents argue this allows titration for optimal effect, but major medical bodies, including the Endocrine Society and American College of Obstetricians and Gynecologists, caution that cBHT lacks rigorous evidence of safety and efficacy compared to regulated therapies, with risks of inconsistent potency and unstudied long-term effects.^[73]^[74]^[75] Other specialized uses include dermatological compounding for custom topical agents in cosmetics or skin conditions, such as ointments excluding preservatives for sensitive patients, and limited research applications where compounded drugs support investigational needs under FDA oversight, though such uses must navigate Investigational New Drug exemptions to avoid regulatory violations.^[10]^[76] These niches highlight compounding's flexibility for unmet needs but underscore the need for stringent quality controls given the absence of standardized manufacturing.^[18]

Advantages

Patient-Specific Customization

Compounding enables the preparation of medications tailored to an individual's unique physiological, therapeutic, or practical requirements, such as precise dosage adjustments based on body weight or age, which commercial products often cannot provide due to standardized manufacturing.^[10] For instance, pediatric patients may receive liquid formulations with adjusted concentrations or flavors to enhance palatability and adherence, while elderly individuals might benefit from lower doses or alternative delivery methods like transdermal creams to accommodate swallowing difficulties.^[55] This customization addresses gaps in mass-produced drugs, where excipients like dyes or preservatives can trigger allergies, allowing pharmacists to omit such components without compromising active ingredients.^[18] In cases of hypersensitivity or intolerance, compounding facilitates allergen-free versions, such as dye-free or preservative-free suspensions, enabling treatment continuity for patients who cannot tolerate commercial formulations.^[10] Hormonal therapies, for example, can be compounded into specific strengths or combined forms not available commercially, supporting individualized endocrine management.^[77] Similarly, for patients requiring unique combinations, such as anti-nausea agents with pain relievers, compounding creates multi-ingredient preparations that improve convenience and reduce pill burden, potentially enhancing compliance.^[55] Evidence indicates that such personalization can promote medication adherence by aligning formulations with patient preferences and needs, thereby fostering better therapeutic outcomes through reduced non-compliance rates.^[55] Guidelines from regulatory bodies emphasize compounding's role in meeting unmet clinical demands, as seen in its application for patients during drug shortages or when standard products fail to deliver optimal bioavailability via customized routes like sublingual or rectal administration.^[18]^[10] However, these benefits rely on prescribers documenting the medical necessity, ensuring the practice remains targeted rather than routine substitution for manufactured drugs.^[77]

Access to Unavailable or Discontinued Formulations

Compounding pharmacies provide patients with access to drug formulations discontinued by manufacturers, often due to insufficient commercial demand rather than safety or efficacy issues.^[78]^[79] This capability addresses gaps in the pharmaceutical supply chain, enabling continued treatment for individuals reliant on specific medications for chronic conditions, such as certain hormone therapies or topical agents no longer produced at scale.^[80] For instance, pharmacies maintain lists of such unavailable products, compounding equivalents using active pharmaceutical ingredients when clinical need persists.^[81] Under U.S. regulations, Section 503A of the Federal Food, Drug, and Cosmetic Act permits traditional compounding for patient-specific prescriptions, including recreations of discontinued formulations, provided they are not essentially copies of FDA-approved products outside of shortage scenarios.^[82] The FDA explicitly allows compounding during listed drug shortages, which frequently overlap with discontinuations, to mitigate disruptions; as of August 2025, policies enable outsourcing facilities to fulfill orders placed during active shortages even post-resolution under certain conditions.^[83]^[84] However, compounding is prohibited for drugs withdrawn from the market due to safety concerns or those presenting demonstrable formulation difficulties, ensuring that access prioritizes viable, non-recalled therapies.^[54] This mechanism has proven essential in cases like temporary shortages of glucagon-like peptide-1 (GLP-1) agonists, where compounders supplied semaglutide formulations to maintain patient access amid supply constraints, though such practices faced scrutiny from manufacturers alleging infringement.^[85] By leveraging bulk ingredients and customization, compounding extends the lifecycle of otherwise obsolete medications, supporting niche therapeutic needs without requiring new FDA approvals, which can take years and substantial investment.^[36] Overall, it fulfills unmet medical demands, particularly for patients intolerant to excipients in reformulated commercial alternatives or those in remote areas with limited options.^[82]

Risks and Criticisms

Contamination and Potency Issues

Compounded sterile preparations carry significant risks of microbial contamination due to insanitary conditions in compounding environments, which can result in serious patient harm or death.^[86] Poor practices, such as inadequate cleaning of equipment or improper handling, often introduce bacteria or fungi into products intended for injection or inhalation, as evidenced by FDA analyses of failed sterility tests in inspected facilities.^[18] The absence of current good manufacturing practices (cGMP) in traditional compounding exacerbates these vulnerabilities, with studies documenting higher rates of contamination in non-FDA-approved settings compared to manufactured drugs.^[87] Potency inconsistencies in compounded drugs arise from variability in ingredient sourcing, measurement errors, and stability degradation, leading to sub-potent or super-potent formulations that undermine therapeutic efficacy or increase toxicity.^[88] For instance, evaluations of compounded oral chemotherapy agents like chlorambucil have shown potency deviations exceeding 10% from labeled strengths in multiple samples, attributed to formulation instability over time.^[89] Similarly, compounded vitamin D supplements have demonstrated significant potency shortfalls, with some products containing less than 70% of declared cholecalciferol content, highlighting challenges in achieving uniform dissolution and bioavailability without standardized manufacturing controls.^[90] These issues persist despite guidelines like USP <797>, as compounding pharmacies often lack the analytical capabilities for routine potency verification, resulting in reliance on presumptive stability data rather than empirical testing.^[91]

Human Error and Oversight Gaps

Human errors in pharmaceutical compounding often stem from manual calculations, ingredient selection, and measurement processes, which lack the standardization of manufactured drugs. A review of 2,155 adverse event reports identified 63 compounding-related errors, with 21 involving incorrect concentrations that harmed 36 patients, highlighting the vulnerability of custom formulations to arithmetic mistakes such as decimal point misplacements.^[9] Systematic analyses of intravenous compounding errors report rates varying widely by type, including wrong drug selections from 0% to 4.7% and incorrect diluent choices up to 49%, underscoring how procedural variability amplifies risks in non-routine preparations.^[92] In community and hospital settings, dispensing errors tied to compounding occur at a pooled prevalence of 1.6%, with approximately 1 in 100 such errors leading to adverse drug events, often due to inadequate double-checks or fatigue during high-volume operations.^[93]^[94] Oversight gaps exacerbate these errors through fragmented regulatory authority and inconsistent state-level enforcement. The U.S. Government Accountability Office (GAO) has noted that limited federal jurisdiction over traditional compounding pharmacies creates enforcement challenges, as the Food and Drug Administration (FDA) must often secure warrants for inspections—requiring 11 such actions between 2002 and 2012 alone—allowing quality lapses to persist undetected.^[95]^[96] State boards vary in inspection frequency and standards, with some lacking resources for routine audits of sterile compounding, leading to undetected deviations in training or protocol adherence.^[97] Compounding errors appear in only 3% of screened pharmacovigilance reports but frequently result in patient harm, partly because post-market surveillance relies on voluntary reporting rather than mandatory, real-time monitoring.^[55] These gaps persist despite post-2012 reforms, as evidenced by ongoing FDA warnings about inadequate personnel qualifications and failure to implement corrective actions in inspected facilities.^[98]

Notable Incidents

Pre-2012 Outbreaks and Violations

Prior to the 2012 fungal meningitis outbreak, multiple outbreaks of infections were traced to contaminated sterile compounded drugs produced by pharmacies, often due to failures in sterilization, environmental controls, or aseptic processing. These incidents, primarily involving injectable products administered epidurally or intravenously, resulted in dozens of infections and at least several deaths across various states, underscoring longstanding vulnerabilities in compounding practices despite FDA warnings and state inspections. A congressional review identified at least 23 deaths and 86 serious illnesses or injuries linked to compounding pharmacies from 2001 onward, with common violations including operation of non-sterile facilities, distribution of unapproved or adulterated drugs without valid prescriptions, and large-scale production mimicking manufacturing.^[9] In 2001, an outbreak in California involved betamethasone injections contaminated with Serratia marcescens bacteria, stemming from inadequate autoclaving at an ambulatory surgery center sourcing from a compounding pharmacy; 11 patients developed infections following epidural or joint injections, with 3 fatalities.^[9] Similarly, in 2002, a South Carolina pain clinic reported 6 cases of fungal infections, including 1 death, from methylprednisolone acetate contaminated with Exophiala dermatitidis due to improper sterilization and environmental mold exposure during compounding.^[99]^[9] That same year in Michigan, 2 patients suffered bacterial meningitis after epidural injections of methylprednisolone tainted with Chryseomonas luteola, highlighting persistent contamination risks in steroid compounding.^[9] Additional pre-2012 violations included a 2005 outbreak in Virginia of systemic inflammatory response syndrome tied to contaminated compounded products from a pharmacy, though exact case counts were not publicly detailed in federal reports.^[9] In 2006, a multistate incident involved Serratia marcescens bloodstream infections from contaminated intravenous magnesium sulfate distributed by a compounding pharmacy, affecting multiple patients and prompting FDA investigations into sourcing and sterility lapses.^[100] By 2007, similar Serratia contamination in compounded magnesium sulfate led to further bloodstream infections across states, linked to inadequate quality controls.^[101] In 2011, an Alabama compounding pharmacy, Meds IV, supplied total parenteral nutrition (TPN) solutions contaminated with bacteria, contributing to 9 patient deaths and infections in at least 10 others at a hospital; the incident involved failures in sterility testing and facility maintenance, resulting in a nationwide recall. These events often evaded robust federal oversight, as compounding pharmacies operated under state pharmacy board jurisdiction, with FDA limited to post-market interventions like warning letters for cGMP violations, such as producing drugs in unsanitary conditions or without proper documentation.^[9] Despite these red flags, regulatory gaps persisted, as pharmacies frequently scaled up production beyond traditional patient-specific needs without adopting manufacturer-level standards.

2012 New England Compounding Center Crisis

In September 2012, the New England Compounding Center (NECC), a compounding pharmacy based in Framingham, Massachusetts, distributed contaminated lots of preservative-free methylprednisolone acetate (MPA), a steroid injected for back and joint pain relief, triggering a multistate outbreak of fungal infections including meningitis, arachnoiditis, and paraspinal infections.^[102] The contamination primarily involved the black mold Exserohilum rostratum, with some cases linked to Aspergillus fumigatus, introduced during non-sterile compounding processes at NECC's facility.^[103] On September 26, 2012, NECC voluntarily recalled the three implicated lots of MPA after initial reports of illnesses in Tennessee, but the outbreak expanded rapidly as patients who received injections from September 21 onward fell ill with symptoms such as headache, fever, and neurological deficits.^[104] The crisis affected 753 patients across 20 states who received the tainted injections, resulting in 64 deaths, predominantly from fungal meningitis; non-meningitis infections added further morbidity, including strokes and abscesses requiring surgical intervention.^[105] Investigations by the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and Massachusetts Board of Registration in Pharmacy revealed systemic failures at NECC, including inadequate sterilization of drug vials, use of contaminated equipment, and falsified sterility test results; environmental sampling confirmed mold presence in clean rooms, and bulk drug solutions tested positive for fungal growth despite negative potency checks.^[102] NECC had produced over 17,000 vials from these lots in batches exceeding traditional patient-specific compounding, shipping them directly to clinics without proper validation of aseptic techniques, which blurred lines between pharmacy compounding and large-scale manufacturing.^[106] Federal and state probes uncovered prior regulatory lapses, with FDA inspections as early as 2006 citing "insanitary conditions" and warning letters in 2006 and 2011 for sterility issues that were not adequately addressed, allowing NECC to continue operations under lax state pharmacy oversight.^[106] NECC owner Barry J. Cadden and other executives faced criminal charges; in 2017, Cadden was convicted on racketeering and fraud counts leading to the outbreak, sentenced to 14 years in prison for prioritizing production speed over safety protocols like proper gowning and air filtration.^[105] The incident prompted the 2013 Drug Quality and Security Act, which distinguished traditional compounding under Section 503A from outsourcing facilities under Section 503B, imposing stricter federal standards for sterile compounding to prevent recurrence by mandating adverse event reporting and FDA inspections for high-volume producers.^[106]

Incidents and Responses Since 2013

In response to the 2012 New England Compounding Center outbreak, the U.S. Congress enacted the Drug Quality and Security Act (DQSA) on November 27, 2013, which amended the Federal Food, Drug, and Cosmetic Act to establish Section 503A for traditional patient-specific compounding by state-licensed pharmacies and Section 503B for registered outsourcing facilities subject to federal current good manufacturing practice (cGMP) standards, including FDA inspections and adverse event reporting. These provisions aimed to clarify boundaries between compounding and manufacturing while enhancing oversight of sterile compounding to mitigate contamination risks. The FDA subsequently issued guidance documents on sterile compounding standards and began registering 503B facilities, with over 70 operational by 2016.^[107] Despite these reforms, contamination incidents persisted in the immediate aftermath. In March 2013, Med Prep Consulting in New Jersey recalled all sterile products after a Connecticut hospital identified mold contamination in five bags of magnesium sulfate intended for patient use, prompting FDA warnings on sterility assurance.^[108] In August 2013, Specialty Compounding Pharmacy in Cedar Park, Texas, initiated a nationwide voluntary recall of all sterile products following reports of 15 bacterial bloodstream infections and two deaths among patients who received contaminated calcium gluconate infusions prepared under insanitary conditions, including inadequate environmental controls. The FDA investigation revealed failures in aseptic processing, leading to the pharmacy ceasing sterile operations.^[109] Additional 2013 events included adverse reactions from compounded methylprednisolone acetate injections, affecting 26 patients across 17 states with skin abscesses and other infections due to bacterial contamination from poor facility sanitation; the implicated pharmacy recalled all sterile drugs and halted production.^[107] Later incidents highlighted potency and hypersensitivity risks: in 2015, Glades Drugs recalled compounded multivitamin capsules nationwide after reports of excessive Vitamin D3 levels linked to potential toxicity adverse events.^[107] In 2016, a super-potent compounded morphine sulfate injection (2,460% above labeled strength) caused respiratory depression in three infants, prompting an immediate recall.^[107] Post-2016, the FDA documented further issues, including a July 2017 case where at least 43 patients experienced vision loss after intraocular injections of a compounded steroid-antiinfective combination, attributed to formulation instability, leading to an FDA safety alert against such unapproved combinations.^[110] In August 2017, two patients suffered severe hypersensitivity reactions—one fatal—following intravenous compounded curcumin infusions containing unapproved excipients, resulting in another FDA risk alert emphasizing excipient evaluation.^[110] No incidents matched the 2012 outbreak's scale, but these underscored gaps in 503A facilities' voluntary standards. Regulatory responses evolved with intensified enforcement: by December 2017, the FDA had inspected over 425 compounding sites, issuing warning letters for recurrent cGMP violations like inadequate microbial testing and facility design flaws.^[110] From 2017 to 2022, FDA warning letters to pharmacies emphasized sterility assurance failures (cited in 80% of cases) and insufficient quality systems, reflecting systemic compliance challenges despite DQSA.^[111] State boards enhanced inspections, and federal-state partnerships improved reporting, yet reports of violations in large compounders, such as repeated citations at Empower Pharmacy for potency inconsistencies and documentation lapses through 2024, indicate ongoing oversight demands.^[112] These actions have reduced large-scale outbreaks but highlight persistent risks from non-standardized practices in traditional compounding.

Regulatory Framework

United States Oversight

In the United States, pharmaceutical compounding is regulated through a dual federal-state framework established primarily by the Drug Quality and Security Act (DQSA), enacted on November 27, 2013, as part of the Consolidated Appropriations Act, 2014.^[48]^[113] The DQSA amended the Federal Food, Drug, and Cosmetic Act to differentiate between traditional patient-specific compounding under Section 503A and larger-scale operations by outsourcing facilities under Section 503B, addressing deficiencies exposed by the 2012 New England Compounding Center outbreak that resulted in over 60 deaths from contaminated steroids.^[114] Compounded drugs remain exempt from FDA pre-market approval for safety, efficacy, and quality, unlike manufactured drugs, which has led to persistent variability in oversight efficacy.^[18]^[115] State boards of pharmacy hold primary licensing and inspection authority for most compounding activities, while the FDA exercises federal oversight through risk-based inspections, enforcement actions, and guidance on bulk drug substances, adverse event reporting, and interstate distribution limits.^[116]^[117] As of 2025, the FDA has intensified scrutiny on compounded versions of shortage drugs like GLP-1 agonists, issuing warnings on unapproved advertising and clarifying policies to curb non-FDA-approved claims, amid proposed legislation such as the Drug Shortage Compounding Patient Access Act to facilitate access during shortages without undermining standards.^[84]^[118]

Section 503A Traditional Compounding

Section 503A governs traditional compounding pharmacies that prepare drugs for individual patients based on a valid prescription or practitioner notation, exempting them from new drug application requirements if they avoid large-scale production, interstate bulk shipping, or duplicating commercially available FDA-approved drugs.^[48]^[54] These facilities, numbering in the thousands nationwide, are not required to register with the FDA or undergo routine federal inspections; instead, state pharmacy boards conduct oversight, enforcing compliance with United States Pharmacopeia standards for ingredients and processes.^[116]^[119] The FDA intervenes only in cases of significant risk, such as contamination outbreaks or violations of federal conditions like using non-compliant bulk substances, with authority to issue warnings, seize products, or pursue injunctions.^[54] Limitations include prohibitions on compounding drugs withdrawn from the market for safety reasons or those presenting demonstrable difficulties, as listed by the FDA.^[113]

Section 503B Outsourcing Facilities

Section 503B applies to registered outsourcing facilities that compound sterile or non-sterile drugs in larger batches, often without patient-specific prescriptions, for distribution to healthcare providers or hospitals, provided they adhere to current good manufacturing practices (cGMP) akin to those for approved drugs.^[19]^[120] As of 2025, approximately 50-60 such facilities operate voluntarily under FDA registration, submitting semi-annual drug lists, adverse event reports within 15 days, and undergoing unannounced FDA inspections for cGMP compliance, including facility design, quality control, and labeling.^[116]^[121] Unlike 503A entities, 503B facilities face federal recall authority and restrictions on using bulk substances not on FDA-approved lists or interim policies, with recent guidance prohibiting certain compounding during shortages pending rulemaking.^[122] Violations can result in product holds, import alerts, or criminal penalties, reflecting heightened post-DQSA enforcement to mitigate risks from scaled production.^[121]^[115]

Section 503A Traditional Compounding

Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Drug Quality and Security Act (DQSA) signed into law on November 27, 2013, establishes conditions under which licensed pharmacists in state-licensed pharmacies or federal facilities, or licensed physicians, may compound drugs for individual patients without the product being subject to new drug application requirements, certain labeling mandates, or FDA approval processes.^[123]^[113] This provision targets traditional compounding, defined as the preparation of drugs tailored to specific patient needs based on a valid prescription from a licensed practitioner, distinguishing it from large-scale manufacturing by prohibiting anticipatory compounding for resale or office use without patient-specific orders.^[124]^[125] Compounding under 503A must generally occur after receipt of the prescription, though limited exceptions allow for small-batch preparation in response to anticipated needs if state law permits and records demonstrate patient-specific intent.^[125] Key restrictions include prohibitions on advertising or promoting the compounding of particular drugs or classes, distributing compounded drugs interstate beyond 5% of total distribution unless to other 503A entities, and using bulk drug substances not on FDA's evaluated lists or meeting specific monograph criteria, to prevent compounding from resembling commercial manufacturing.^[123] Compounded products cannot be essentially copies of commercially available FDA-approved drugs unless a clinical need justifies customization, such as allergies or dosage adjustments.^[125] Oversight falls primarily to state regulatory boards, with compounders required to comply with United States Pharmacopeia (USP) standards like <795> for non-sterile and <797> for sterile preparations, rather than current good manufacturing practices (cGMP) mandatory for 503B facilities.^[116]^[126] The FDA may intervene for violations posing significant health risks, but does not conduct routine inspections of 503A entities, emphasizing state-level enforcement to balance patient access with safety post-2012 contamination crises.^[116]^[127]

Section 503B Outsourcing Facilities

Section 503B outsourcing facilities, established under the Drug Quality and Security Act (DQSA) enacted on November 27, 2013, enable registered compounders to produce sterile drug products in larger batches for distribution to healthcare facilities without requiring patient-specific prescriptions.^[128] These facilities address the need for scalable compounding following the 2012 fungal meningitis outbreak linked to the New England Compounding Center, which highlighted risks in unregulated large-scale operations.^[129] Unlike traditional compounding under section 503A, 503B facilities operate under federal oversight, permitting interstate distribution while prohibiting the compounding of drugs that replicate commercially available approved products absent a documented shortage.^[128] To qualify, a facility must register annually with the FDA, demonstrating compliance with current good manufacturing practices (cGMP) tailored for compounding, as outlined in FDA guidance issued January 7, 2021.^[130] Compounding occurs under the direct supervision of a licensed pharmacist within a single geographic location, with requirements for process validation, environmental monitoring, and sterility testing for all sterile products, including separate endotoxin assessments where applicable.^[131] Facilities must source bulk drug substances from FDA-approved lists under section 503B or meet specific criteria for interim use, ensuring substances are accompanied by certificates of analysis and manufactured under cGMP.^[132] Adverse drug events must be reported to the FDA within 15 business days, and facilities are subject to unannounced inspections, with non-compliance potentially leading to registration revocation or product recalls.^[128] Prohibitions include wholesaling compounded drugs to other entities for further distribution and compounding essentially similar copies of approved drugs, as clarified in FDA draft guidance from June 28, 2023, to prevent circumvention of new drug approval processes.^[133] Labeling must identify the product as compounded and include beyond-use dates based on stability data, with facilities maintaining records for FDA review.^[130] As of January 2025, outsourcing facilities may only use bulk substances explicitly listed on FDA's 503B bulks list to ensure safety and quality control.^[132] This framework balances access to customized drugs—such as for hospital use during shortages—with rigorous federal standards exceeding those for section 503A pharmacies, which rely on state regulation and patient-specific orders.^[116]

International Approaches

Internationally, pharmaceutical compounding is regulated with a focus on scale and risk, often exempting small-scale, patient-specific preparations from full manufacturing standards while mandating professional guidelines to ensure sterility and potency. This contrasts with large-volume operations, which may trigger good manufacturing practice (GMP) requirements similar to those for approved drugs. Countries prioritize provincial or state-level pharmacy oversight to maintain flexibility for customized medications, informed by incidents like fungal meningitis outbreaks that highlighted contamination risks in non-traditional compounding.^[134]^[135]

Canadian Regulations

In Canada, compounding falls under the Food and Drugs Act but is primarily governed by provincial colleges of pharmacy, with Health Canada providing federal policy distinctions between compounding and manufacturing. Compounding is defined as the preparation of a drug or mixture in direct response to a prescription for an individual patient, typically in small quantities, exempting it from site licensing and full GMP if it does not involve systematic production for resale or storage.^[134] Operations exceeding this—such as bulk preparation or non-prescription-driven production—are classified as manufacturing, requiring compliance with Division 2 of the Food and Drug Regulations, including GMP for fabrication, packaging, testing, and storage.^[136] The National Association of Pharmacy Regulatory Authorities (NAPRA) supports harmonized standards, though enforcement remains decentralized, leading to variations in sterile compounding protocols across provinces like Ontario and British Columbia.^[134]

Australian Standards

Australia regulates compounding through the Therapeutic Goods Administration (TGA) at the federal level and state-based pharmacy boards, applying PIC/S GMP principles selectively to extemporaneous preparations made in response to individual prescriptions. The Pharmacy Board of Australia mandates guidelines for compounding medicines, requiring risk assessments, aseptic processing, and batch documentation for sterile products to prevent errors like those in potency deviations or microbial contamination.^[137] Larger-scale or pre-prepared compounded medicines, such as dose administration aids, must adhere to clarified GMP exemptions only if low-risk and non-commercial; otherwise, a manufacturing license under the Therapeutic Goods Act 1989 is required, including validation of processes and stability testing.^[135] Recent TGA actions, including restrictions on compounding glucagon-like peptide-1 receptor agonists like semaglutide since 2023, underscore heightened scrutiny for high-demand custom drugs, prohibiting supply without prescriptions and emphasizing quality controls amid supply shortages of approved versions.^[138]^[139]

Canadian Regulations

In Canada, pharmaceutical compounding is primarily regulated at the provincial and territorial levels by pharmacy regulatory authorities, which adopt and enforce the National Association of Pharmacy Regulatory Authorities (NAPRA) Model Standards for Pharmacy Compounding as minimum requirements.^[140] These standards, first developed in the mid-2010s and revised periodically, distinguish compounding—defined as the preparation of drugs by licensed pharmacists or technicians in response to individual prescriptions—from manufacturing, which involves larger-scale production and requires compliance with Good Manufacturing Practices (GMP) under the Food and Drugs Act.^[134] NAPRA's framework emphasizes risk-based approaches, with separate models for non-sterile preparations, non-hazardous sterile preparations, and hazardous sterile preparations to mitigate contamination and stability risks. The Model Standards for Pharmacy Compounding of Non-sterile Preparations, updated in March 2018 with clarifications in January 2022, require pharmacies to implement policies for personnel training, facility design (including dedicated areas to prevent cross-contamination), equipment calibration, and documentation such as master formulation records and compounding logs.^[141] For sterile compounding, the non-hazardous and hazardous models, revised in November 2016 and beyond, mandate controlled environments akin to ISO Class 5 cleanrooms for critical tasks, environmental monitoring, aseptic processing validation, and beyond-use dating based on risk levels (low, medium, high).^[142] Hazardous preparations, such as those involving antineoplastics, require additional containment like biological safety cabinets and negative-pressure rooms to protect handlers and patients.^[143] Pharmacies must perform regular quality assurance, including media fills for sterility testing and stability assessments, with non-compliance risking license suspension by provincial bodies. Health Canada's Policy on Manufacturing and Compounding Drug Products in Canada (POL-0051), issued October 26, 2020, clarifies that compounding by licensed pharmacists in retail or hospital settings for immediate patient use is exempt from federal manufacturing site licensing and GMP if it adheres to NAPRA standards and avoids anticipatory production or bulk resale.^[134] However, compounded products remain subject to the Food and Drugs Act's prohibitions on adulteration, misbranding, and unsafe advertising, with Health Canada intervening in cases of widespread distribution resembling manufacturing, as seen in warnings against unauthorized semaglutide compounding in June 2025 due to safety and efficacy concerns.^[144] Provincial variations exist—for instance, Ontario's College of Pharmacists enforces NAPRA standards with additional audits—but national consistency is promoted through NAPRA's oversight, aiming to prevent incidents like contamination outbreaks by prioritizing verifiable processes over commercial scalability.^[145]

Australian Standards

In Australia, pharmaceutical compounding is overseen by the Therapeutic Goods Administration (TGA) and the Pharmacy Board of Australia, with standards derived from the Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice (GMP) for medicinal products.^[135]^[146] Compounded medicines prepared for individual patients on a doctor's prescription are exempt from inclusion on the Australian Register of Therapeutic Goods (ARTG), provided they are not produced in anticipation of demand or supplied in bulk, but they must still adhere to principles of quality, safety, and efficacy under GMP interpretations tailored to compounding.^[135]^[147] The Pharmacy Board of Australia's Guidelines on Compounding of Medicines, revised in August 2024, mandate that pharmacists maintain documented procedures for compounding, including risk assessments, raw material sourcing from licensed suppliers, and stability testing where applicable, to ensure product consistency and prevent contamination.^[148] For non-sterile extemporaneous compounding, such as creams or oral liquids, pharmacies must implement hygiene protocols, calibrated equipment, and labeling with beyond-use dates based on evidence or compendial standards, without requiring a full manufacturing license.^[149]^[148] Sterile compounding, involving injectables or ophthalmics, demands heightened controls aligned with PIC/S GMP Annex 1 for sterile products, including cleanroom facilities with ISO-classified environments (e.g., Grade A for critical zones), environmental monitoring for particulates and microbes, and validated aseptic processes to mitigate risks like those seen in global contamination outbreaks.^[135]^[137] Facilities producing multiple units or batches for sterile compounded medicines typically require TGA manufacturing licenses, subjecting them to inspections for personnel training, equipment qualification, and quality control testing such as sterility and endotoxin assays.^[135]^[150] TGA guidance emphasizes interpreting PIC/S GMP chapters—such as those on premises (Chapter 3), equipment (Chapter 3), documentation (Chapter 4), and quality control (Chapter 6)—flexibly for small-scale pharmacy compounding while prohibiting practices that mimic commercial manufacturing without licensure, like pre-packaging for resale.^[135] Non-compliance can result in enforcement actions, including product recalls or license revocation, as evidenced by TGA interventions in cases of substandard compounded injectables reported since 2017.^[137] These standards prioritize patient-specific customization over mass production, reflecting Australia's harmonization with international GMP frameworks to balance access with risk mitigation.^[146]

Economic and Societal Impact

Market Dynamics and Innovation

The U.S. compounding pharmacies market was valued at approximately USD 6.31 billion in 2024 and is projected to reach USD 10.76 billion by 2033, growing at a compound annual growth rate (CAGR) of about 5.7%.^[151] ^[152] This expansion is driven by rising demand for personalized medications, such as those tailored for patients with allergies to commercial drug excipients or those requiring unique dosages, alongside periodic drug shortages that necessitate compounded alternatives.^[153] Globally, the market is expected to grow from USD 13.48 billion in 2024 to USD 19.41 billion by 2030 at a similar CAGR, reflecting increased healthcare needs in aging populations and chronic disease management.^[152] Market dynamics have been shaped by the distinction between Section 503A traditional compounding pharmacies, which produce patient-specific prescriptions without current good manufacturing practices (cGMP) requirements, and Section 503B outsourcing facilities, which operate under stricter cGMP standards to enable bulk compounding for hospitals and clinics without individual prescriptions.^[19] The 503B segment, valued at USD 1.08 billion in 2023, is anticipated to double to USD 2.25 billion by 2033 with a 7.63% CAGR, outpacing 503A due to its ability to address large-scale sterile injectable needs during shortages, such as those for GLP-1 agonists in 2023-2024.^[154] ^[155] Post-2012 fungal meningitis outbreak regulations under the Drug Quality and Security Act have shifted dynamics toward 503B facilities, increasing barriers for smaller 503A pharmacies through higher compliance costs, while fostering competition with FDA-approved manufacturers by allowing compounded versions of drugs in short supply—though this has raised concerns about undermining incentives for branded drug innovation via patent circumvention.^[156] Innovation in compounding has focused on enhancing precision, sterility, and efficiency to meet regulatory demands like USP <797> standards for sterile preparations. Adoption of robotic automation systems for intravenous compounding has reduced human error rates by up to 90% in controlled studies, enabling consistent dosing and minimizing contamination risks in high-volume 503B operations.^[53] ^[158] Integration of artificial intelligence for formulation optimization and real-time quality monitoring is emerging, particularly for personalized therapies like precision-dosed hormone replacements or novel delivery systems such as nanoencapsulation for improved bioavailability.^[159] ^[160] These advancements, while elevating costs—estimated to add 20-30% to operational expenses for compliant facilities—have supported market resilience by enabling rapid adaptation to shortages, though critics argue they divert resources from broader pharmaceutical R&D investments.^[10]^[161]

Effects of Regulation on Access and Costs

The Drug Quality and Security Act (DQSA) of 2013, enacted following the 2012 fungal meningitis outbreak linked to contaminated compounded steroids that caused 64 deaths and over 800 illnesses, established sections 503A and 503B to differentiate traditional patient-specific compounding from large-scale outsourcing while imposing stricter federal oversight, including current good manufacturing practices (cGMP) for 503B facilities.^[162] These measures aimed to enhance safety but introduced compliance burdens, such as facility registration, adverse event reporting, and ingredient sourcing restrictions, which elevated operational costs for pharmacies. Empirical data indicate a sharp rise in compounded medication costs post-DQSA. The average ingredient cost per compounded prescription increased 130.3% from $308.49 in 2012 to $710.36 in 2013, compared to a 7.7% rise for non-compounded prescriptions over the same period; total ingredient spending on compounded drugs surged from $134 million to $457 million.^[163] This escalation correlates with regulatory requirements for quality controls, documentation, and sterile processing, which disproportionately affected smaller 503A pharmacies lacking economies of scale. While 503B outsourcing facilities enable bulk production to potentially reduce per-unit costs through larger batches, initial setup and cGMP compliance—estimated to require investments in cleanrooms and testing—have broadly driven up prices, limiting affordability for patients reliant on custom formulations during drug shortages or for allergies.^[19] On access, regulations curtailed compounding flexibility by prohibiting "essentially copies" of FDA-approved drugs absent shortages and restricting bulk ingredients, with the FDA denying over 70% of 49 reviewed nominations for bulk substances by 2019, including essentials for arthritis, diabetes, and veterinary use.^[164] Interstate shipping limits (capped at 5% of total sales for 503A) and state-level bans on "office stock" for clinician use have reduced supply chains, prompting some pharmacies to cease certain services and delaying patient care.^[164] Utilization of compounded drugs rose 27.3% from 2012 to 2013 among commercially insured patients, reflecting sustained demand amid shortages, yet per-patient prescriptions remained stable at two annually, suggesting barriers to broader adoption rather than expanded use.^[163] Proponents argue 503B growth— from zero to over 70 facilities by 2018—bolsters access to sterile compounds for hospitals, but critics, including physician groups, contend the framework favors manufactured drugs, sidelining bespoke options without equivalent safety gains for non-sterile compounding.^[165]^[164]

Future Directions

Technological and Methodological Advances

Robotic automation has emerged as a key technological advance in sterile compounding, enabling precise measurement, mixing, and dispensing of intravenous medications while minimizing human error and exposure to hazardous drugs. Systems such as the RIVA robotic IV automation platform and Kiro Oncology Robot have demonstrated improved accuracy, with studies showing reduced compounding errors by up to 90% compared to manual methods and enhanced sterility through closed-system operations.^[166]^[167]^[168] These robots integrate gravimetric verification and barcode scanning, allowing for high-volume preparation in outsourcing facilities compliant with USP <797> standards, and have been adopted in hospitals to increase throughput by 20-50% without compromising safety.^[169]^[170] Three-dimensional (3D) printing represents a methodological innovation for non-sterile compounding, facilitating the production of personalized dosage forms tailored to patient-specific needs, such as pediatric or geriatric doses. This additive manufacturing technique uses fused deposition modeling or binder jetting to create complex geometries, like polypills combining multiple drugs, with bioequivalence confirmed in clinical trials against commercial equivalents.^[171]^[172] Automated 3D printing platforms have been implemented in hospital pharmacies since 2023, reducing preparation time from hours to minutes and enabling on-demand customization, though scalability remains limited by regulatory validation for sterile applications.^[173]^[174] Integration of artificial intelligence (AI) and real-time monitoring systems further advances compounding methodology by optimizing workflows and ensuring quality. AI-assisted platforms, such as technology-assisted workflow systems (TAWS), have improved error detection and traceability in sterile preparations, with one study reporting a 75% reduction in deviations during verification steps.^[175] Innovations like closed-system transfer devices (CSTDs) combined with environmental sensors provide continuous particle and microbial monitoring, accelerating sterility testing from days to hours via rapid microbial methods, thereby supporting faster release of compounded products.^[176]^[177] These developments, driven by post-2012 contamination outbreaks, prioritize causal risk reduction through empirical validation rather than procedural compliance alone.^[178]

Ongoing Policy Debates

One central debate concerns the criteria for using bulk drug substances in compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act, as outlined in FDA's January 2025 interim guidance, which requires compounders to demonstrate clinical need and limit use to substances on interim lists or those nominated with supporting data.^[179]^[180] Advocates for pharmacies argue that restrictive FDA lists hinder timely access to essential customized formulations during shortages, potentially exacerbating patient harm, while FDA emphasizes preventing widespread use of unapproved substances that bypass safety and efficacy reviews, citing historical contamination risks.^[181]^[18] This tension reflects broader concerns over whether interim policies sufficiently balance innovation with risk, with some stakeholders calling for statutory reforms to expedite nominations.^[182] A related flashpoint involves compounding GLP-1 receptor agonists like semaglutide and tirzepatide amid resolved shortages as of 2024-2025, where FDA policies prohibit "essentially copies" of approved drugs absent ongoing shortages, leading to enforcement actions against compounders for unauthorized production and promotion.^[84]^[183] Proponents of expanded compounding access highlight affordability barriers for patients—such as high costs of branded injectables—and unmet needs in non-standard dosages, proposing legislation like the Drug Shortage Compounding Patient Access Act of 2025 to codify flexibility during disruptions. Critics, including FDA and safety advocates, counter that compounded versions evade premarket testing, posing risks of substandard quality or adverse events, as evidenced by increased warning letters in 2025 targeting misleading advertising that blurs lines with approved drugs.^[187] This debate underscores causal trade-offs: enhanced access may drive cost savings but elevates contamination or inefficacy hazards without FDA oversight.^[188] Regulatory tailoring to clinical contexts remains contentious, with FDA and state officials discussing via intergovernmental meetings—such as the November 2023 session—how to adapt standards like USP <795> and <797> revisions without curtailing access for traditional 503A pharmacies serving individual prescriptions.^[189]^[190] Pharmacy groups contend that overly stringent federal rules, post-2012 meningitis outbreak, impose undue burdens on small-scale operations, limiting personalized therapies for allergies or pediatrics, whereas enforcement proponents prioritize uniform quality controls to mitigate systemic risks from interstate distribution.^[36] Empirical data from FDA inspections reveal persistent violations in sterile compounding, fueling arguments for heightened scrutiny over deregulation.^[191] Proposed solutions include clearer shortage declarations and state-federal harmonization, though implementation lags highlight ongoing friction between localized access and national safety imperatives.^[192]

References

[1]
Compounding Interest: Formulas and Examples - Investopedia
Compounding is the process where an asset's earnings, from either capital gains or interest, are reinvested to generate additional earnings over time.What Is Compounding? · Understanding Compounding · Compounding Periods
[2]
How does compound interest work?
Nov 7, 2023 · Compound interest is when you earn interest on the money you've saved and on the interest you earn along the way.
[3]
What is compound interest? | Investor.gov
Compound interest is the interest you earn on interest. For example, if you have $100 and it earns 5% interest each year, you'll have $105 at the end of the ...
[4]
What is compound interest? - Fidelity Investments
Compound interest is when interest earned earns interest of its own, on both the initial balance and accumulated interest.<|separator|>
[5]
[PDF] The oldest example of compound i - arXiv
It is generally agreed that the origin of compound interest can be traced back to the Old Babylonian period (ca. 2000–1600 BCE), because we know that the ...
[6]
The emergence of compound interest | British Actuarial Journal
Dec 24, 2019 · Compound interest was known to ancient civilisations, but as far as we know it was not until medieval times that mathematicians started to analyse it.
[7]
Investing Basics: What is Compound Interest and Growth?
Compound interest is earning returns on your initial investment and accumulated returns, which can help grow your investment over time.
[8]
Compounding, Explained: How It Works - Ellevest
Jul 26, 2023 · Compounding is earning returns on your original investment and accumulated returns over time, earning interest on interest, which makes money ...
[9]
Pharmaceutical Compounding: a History, Regulatory Overview, and ...
Nov 2, 2020 · Compounding is defined by the FDA as the combination, mixing, or alteration of drug ingredients to create medications tailored to individual ...Missing: core | Show results with:core
[10]
An Overview of Compounding - The Clinical Utility of ... - NCBI - NIH
Compounding is the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of a patient (FDA, 2017).Missing: concept | Show results with:concept
[11]
FDA oversight of drug manufacturing and compounding: A comparison
Dec 19, 2024 · In this article, we describe the differences in regulatory authorities and oversight for FDA-approved and compounded drugs.
[12]
[PDF] Compounded vs Manufactured Medications FAQ
How is compounding different than drug manufacturing? Drug manufacturing is the mass production of non-patient specific medications that have been ap- proved by ...
[13]
Manufacturing vs Compounding | MayaScript
Manufacturing is the mass production of drug products that have been approved by the Food and Drug Administration (FDA). These products are sold to ...
[14]
USP General Chapter 795
USP develops standards for compounding nonsterile medications to help ensure patient benefit and reduce risks such as contamination, infection or incorrect ...
[15]
[PDF] General Chapters <795> Pharmaceutical Compounding - USP-NF
Apr 24, 2020 · In the three general categories of nonsterile compounding described in this section, different levels of experience, training, and physical ...
[16]
USP General Chapter 797
USP General Chapter describes a number of requirements, including responsibilities of compounding personnel, training, facilities, environmental monitoring ...Missing: equipment | Show results with:equipment
[17]
[PDF] usp <797> key changes - ashp
“Category 1, Category 2, and Category 3 CSPs can be compounded by using only sterile starting ingredients, or by using some or all nonsterile starting ...
[18]
Compounding and the FDA: Questions and Answers
Sep 16, 2025 · Compounded drugs are not FDA-approved. This means that FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed.
[19]
503A vs. 503B: A Quick-Guide to Compounding Pharmacy ...
Nov 16, 2021 · Learn the differences between 503A and 503B compounding pharmacies and expert advice for maintaining regulatory compliance with the FDA.
[20]
Papyrus Ebers — English - Science in Ancient Egypt
A remedy for opening the abdomen: Milk: 1/16+1/64 (oipe = 4 dja), scored/ripe sycamore fruit: a quarter (dja), [2,10b] honey: a quarter (dja).
[21]
The Ebers Papyrus (left image, ca. 1550 BCE) from Ancient Egypt ...
Ancient Egyptians wrote the Ebers Papyrus (Fig. 1, left), which contains information on over 850 plant medicines, including garlic, juniper, cannabis, castor ...Missing: compounding | Show results with:compounding
[22]
SCIblog - Galen: superstar scientist of the ancient world
Feb 2, 2021 · The Galenic formulation, which deals with the principles of preparing and compounding medicines in order to optimise their absorption, is named ...
[23]
Galenic formulation - Wikipedia
Galenic formulation is named after Claudius Galen, a 2nd Century AD Greek physician, who codified the preparation of drugs using multiple ingredients. Today, ...
[24]
9 – Galen, Experimenter in Drug Compounding
Dec 12, 2014 · Galen (130-200 A.D.) practiced and taught both Pharmacy and Medicine in Rome; his principles of preparing and compounding medicines ruled in the ...Missing: techniques | Show results with:techniques
[25]
A Look at Compounding Medication History and Its Evolution
May 3, 2022 · In the medieval Islamic world, Muslim pharmacists and chemists developed advanced methods of compounding drugs. The first drug store was opened ...
[26]
The Apothecary: A Historical Institution Bridging Medicine and Ph
These guilds regulated the sale of medicinal substances, enforced quality standards, and upheld professional ethics, ensuring the integrity and safety of ...
[27]
The Evolution of Compounding Pharmacies: From Ancient to Modern
Sep 10, 2025 · ... apothecary guilds, and Frederick II's 1240 CE edict legally separated medicine from pharmacy. Pharmacy shaped science itself. Apothecaries ...
[28]
A Brief History of Pharmacopoeias: A Global Perspective - PharmTech
Sep 15, 2019 · Early pharmacopoeias include De Materia Medica (1st century CE). The USP (1820) and BP (1858) were created to standardize drug standards. There ...
[29]
[PDF] Compounding: past, Present AND FUTURE - National Academies
HISTORY OF COMPOUNDING. Early 1900's. • Traditional extemporaneous compounding dominated pharmacy practice. 1945 – 1970s. • Increase in industrial ...
[30]
How Compounding Pharmacies Shape Pharmaceutical Distribution
Aug 5, 2025 · Pre-Industrial Era. Physicians would prescribe patients tinctures, syrups, salves, and tablets that often contained herbs, plants, and roots, ...
[31]
https://www.usp.org/200-anniversary/history-of-medicine-quality
[32]
The History of Medicine Quality - US Pharmacopeia (USP)
In the early 1800s, when people needed medicine, they went to their local apothecary, where the druggist would mix together a medical preparation derived from ...<|separator|>
[33]
The Oldest, Most Symbolic, and Still Vital Part of Pharmacy - PubMed
Medications were prepared by pharmacists for individual patients and compounding was the only source of drugs before mass production by pharmaceutical companies ...
[34]
Emergence of Pharmaceutical Science and Industry: 1870-1930
Jun 20, 2005 · The modern pharmaceutical industry traces its origin to two sources: apothecaries that moved into wholesale production of drugs such as morphine, quinine, and ...
[35]
A history of the pharmaceutical industry - pharmaphorum
Sep 1, 2020 · The roots of the pharmaceutical industry lie back with the apothecaries and pharmacies that offered traditional remedies as far back as the middle ages.1900s - Aspirin Arrives · Post-War Period · Thalidomide And The...
[36]
Compounding Pharmacy Through the Ages - Blog - DiNovo
Jun 29, 2021 · The history of compounding pharmacy dates back to ancient Greece and the colonial United States.
[37]
Navigating the Evolving World of Drug Compounding
Mar 26, 2025 · Drug compounding exists to fulfill an unmet medical need by providing patient access to commercially unavailable drug strengths, formulations, and combinations.
[38]
[PDF] Compounding Medications: Forgotten Past or Bright Future? - IJSAT
Compounding has seen a resurgence in interest for several reasons, including recent technological developments and an increased focus on individualized medicine ...
[39]
The Troubling Rise of "Compound Pharmacies" - Big Think
Oct 20, 2012 · The rise of compound pharmacies is viewed by medical professionals to be a result of greater out-of-hospital care, high drug prices, drug ...<|control11|><|separator|>
[40]
A Timeline of Sterile Compounding Events and Actions Taken
Let's take a look at the history of USP 797, as well as milestones that led to the development of these compounding standards.
[41]
[PDF] Compounding Nonsterile Products in Pharmacies - ASHP
If ingredients are liquids, the pharmacist should consider compounding liquid dosage forms such as solutions, syrups, or elixirs for the final product.<|separator|>
[42]
USP 795: 6 key areas of focus for pharmacy nonsterile compounding
Oct 23, 2024 · Consider making <797> type options, such as gowns, facemasks, hair covers, and shoe covers required for nonsterile compounding, and include this ...
[43]
FDA to Compounders: Know Your Bulks and Excipients Suppliers
Mar 20, 2025 · The agency urges compounders to know your bulk drug substance, or API, and excipient suppliers and know if the supplier is testing the component.Missing: equipment | Show results with:equipment
[44]
[PDF] ASHP Guidelines on Compounding Sterile Preparations
The guidelines aim to help personnel prepare high-quality sterile preparations, ensuring correct identity, purity, strength, and sterility, and appropriate ...
[45]
Triturations & Aliquots - Pharmlabs
A trituration is a dilution of a potent drug powder with an inert diluent powder, usually lactose, in a definite proportion by weight.<|control11|><|separator|>
[46]
Excipients | Pharmlabs
Excipients ; Levigating agent, Liquid used as an intervening agent to reduce the particle size of a powder by grinding, usually in a mortar. Mineral oil
[47]
Compounding Techniques: Overview & Aseptic - StudySmarter
Sep 5, 2024 · Compounding techniques in medicine include trituration, levigation, and geometric dilution to ensure uniform distribution of active ingredients.
[48]
[PDF] USP 1163 QUALITY ASSURANCE IN PHARMACEUTICAL ...
Quality assurance in compounding requires specific training, documentation, defined responsibilities, and testing during and after compounding, guided by ...<|separator|>
[49]
Human Drug Compounding Laws - FDA
Dec 17, 2024 · Compounded drugs are not FDA-approved. This means that FDA does not review these drugs to evaluate their safety, effectiveness, or quality ...
[50]
Human Drug Compounding - FDA
May 15, 2025 · FDA's compounding program aims to protect patients from poor-quality compounded drugs, while preserving access to lawfully-marketed compounded drugs.Regulatory Policy Information · Compounding Laws · Compounding Oversight and...Missing: equipment techniques USP
[51]
[PDF] ASHP Guidelines on Compounding Sterile Preparations
The guidelines aim to help personnel prepare high-quality sterile preparations, ensuring correct identity, purity, strength, and sterility, and appropriate ...
[52]
U.S. Compounding Pharmacies Market Size on Track to Hit
Aug 18, 2025 · The American Pharmacists Association reports about 56,000 community-based or retail pharmacies in the U.S. out of which 7,500 are compounding ...
[53]
Prevalence of Compounding in Independent Community Pharmacy ...
Overall, 94% of respondent pharmacies provided compounding services at the time of this survey. Prescriptions that required compounding represented less than 1% ...Missing: retail statistics
[54]
Compounding Confidence: Navigating Challenges With Innovative ...
Apr 17, 2025 · Pharmacy compounding has significantly declined over the decades, dropping from 60% of medications in the 1940s to just 1% of prescriptions ...<|separator|>
[55]
Regulatory Framework for Compounded Preparations - NCBI - NIH
USP is a nonprofit organization that sets standards for the identity, strength, quality, and purity of ingredients used to make drugs. There are three types of ...Missing: equipment techniques
[56]
The Role of Pharmaceutical Compounding in Promoting Medication ...
Aug 31, 2022 · The role of pharmaceutical compounding in promoting medication adherence is underexploited. The customization might represent a positive reinforcement.
[57]
[PDF] Pharmacy Sterile Compounding Summit Summary of Proceedings
Compounding methods include admixture, reconstitution, and repackaging of. FDA-approved sterile ingredients. In other compounding models that serve the retail ...
[58]
A critical opinion-based review of hospital pharmacy compounding ...
Feb 13, 2025 · Hospital pharmacies play a unique role in healthcare by regularly compounding drug products (DPs) in response to hospital demands and ...
[59]
Sterile Compounding | CompleteRx
Jul 1, 2024 · Sterile compounding is a complex but vital aspect of hospital pharmacy practice. Ensuring the safety and sterility of compounded medications ...<|separator|>
[60]
The Impact of USP 797, USP 800 on Compounding Pharmacies
Apr 22, 2022 · In USP 797, the guidance establishes standards for sterile compounding to ensure accuracy and avoid contamination of sterile products. 1 On the ...
[61]
USP 797 and USP 795: Creating and Managing a State of Control
It focuses on ensuring that compounding pharmacies provide the conditions and institute practices to prevent harm to patients from microbial, chemical or ...
[62]
Implementation of safety standards of compounded sterile ... - NIH
The use of advanced technologies, such as bar code verification or IV robotics, for compounding sterile preparations was not implemented in 27 (69%) hospitals.
[63]
FDA highlights concerns with compounding of drug products by ...
Oct 25, 2021 · FDA has become increasingly aware of drug products compounded at medical offices and clinics that were prepared under insanitary conditions.
[64]
Addressing Sterile IV Compounding Challenges | Wolters Kluwer
Sep 3, 2024 · Adopting pharmacy compounding solutions like technology-enabled IV workflow management is becoming the gold standard for hospital pharmacies ...
[65]
Medication Compounding Certification - Joint Commission
Medication Compounding certification helps compounding pharmacies achieve optimal safety and reliability in compounding practices.
[66]
What Is a Veterinary Compounding Pharmacy? - PetMD
Dec 18, 2024 · The most common forms of compounded drugs used in veterinary medicine include transdermal gels, capsules, flavored suspensions (oral liquids), ...
[67]
Compounding Pharmacies Can Help - Veterinary Partner - VIN
Sep 11, 2020 · If your veterinarian needs a compounding pharmacy to make a flavored oral liquid or conveniently sized capsule, a compounding pharmacy may be ...Missing: applications | Show results with:applications
[68]
Veterinary Compounding: Regulation, Challenges, and Resources
Jan 10, 2017 · The scope of veterinary compounding is broad and focused primarily on meeting the therapeutic needs of companion animals and not food-producing animals.
[69]
Animal Drug Compounding - FDA
Oct 28, 2024 · Animal drug compounding is the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual animal or a ...
[70]
Compounding | American Veterinary Medical Association
Compounding of drugs is necessary in veterinary medicine to provide individualized medication for animal patients with special needs.
[71]
The Most Common Veterinary Uses for Compounded Prescriptions
Compounded prescriptions help with digestive issues, reduce allergies, access hard-to-find drugs, and provide proper dosing for animals.
[72]
Compounded Bioidentical Menopausal Hormone Therapy - ACOG
This document focuses specifically on the use of compounded bioidentical menopausal hormone therapy, not compounding for other evidence-based reasons.
[73]
Compounded Bioidentical Hormone Therapy - U.S. Pharmacist
Sep 16, 2020 · Compounded hormone therapy (CHT) has become more prominent, as it has been touted as a biologically equivalent alternative to synthetic hormones.
[74]
Compounded Bioidentical Hormone Therapy - Endocrine Society
Compounded “Bioidentical” Hormone Therapy (cBHT), particularly estrogen and progesterone, have been promoted by some as safer and more effective alternatives.
[75]
Bioidentical Hormones: Therapy, Uses, Safety & Side Effects
All hormone replacement therapy comes with risks. Compounded bioidentical hormones may come with more risk because their effects are not well studied. Talk to ...
[76]
The dangers of compounded bioidentical hormone replacement ...
Compounded bioidentical hormone replacement therapy does not carry the safety warnings for estrogen products that are in all prescribed HRT preparations.
[77]
Compounded Drugs in Research: Navigating IND Exemptions and ...
Dec 26, 2024 · However, it's important to note that compounded drugs are not FDA-approved and lack the comprehensive safety, efficacy, and quality assurances ...
[78]
Compounded Medications: Reviewing Safety and Effectiveness
What is Compounding? Compounding is the process of combining, mixing, or altering ingredients to create a medication tailored to the medical needs of a patient.
[79]
Compounds for Discontinued Products (Physician-Only Section)
Compounding can fill a need when commercial products have been discontinued by the manufacturer for economic reasons as opposed to clinical reasons.
[80]
Compounding Pharmacies - Applied Policy
Sep 9, 2024 · ... formulations without allergens such as preservatives or dyes. Compounding can also provide patients access to discontinued (but not formally ...
[81]
Unavailable & Discontinued Medications
Many compounding pharmacies do not compound medications that were discontinued due to safety concerns. Sometimes only certain doses and dosage forms of a ...
[82]
Unavailable Medications - Hill's Compounding Pharmacy
View a regularly updated list of unavailable medications, drug shortages and discontinued medications based upon the FDA Drug Shortages webpage.
[83]
[PDF] Compounded Drug Products That Are Essentially Copies of ... - FDA
Sections 503A and. 503B restrict the compounding of drug products that are essentially copies of commercially available (section 503A) or approved drug products ...
[84]
Compounding when Drugs are on FDA's Drug Shortages List
Aug 8, 2025 · FDA policy provides flexibility when an outsourcing facility fills orders that it received for a compounded drug while the drug was in shortage.
[85]
FDA clarifies policies for compounders as national GLP-1 supply ...
FDA has determined the shortage of semaglutide injection products, a glucagon-like peptide 1 (GLP-1) medication, is resolved.
[86]
Pharmaceutical Disruption: Are Compounding Pharmacies a Friend ...
Compounding pharmacies create personalized medications, address unmet needs, and fill gaps in supply, but can disrupt traditional pharmaceutical models.
[87]
Understanding the Risks of Compounded Drugs | FDA
Sep 16, 2025 · Insanitary conditions can cause drugs to become contaminated and lead to serious patient injury and death. Risk-based oversight, providing ...
[88]
Potential Risks of Pharmacy Compounding - PMC - NIH
Mar 23, 2013 · Compounded sterile preparations pose the additional risk of microbial contamination to patients. In the last 11 years, three separate ...
[89]
Evaluation of drug content (potency) for compounded and FDA ...
Oct 1, 2017 · Compounded formulations may also vary in content, bioavailability, stability, safety, and efficacy when compared with FDA-approved products, and ...
[90]
Potency and Stability of Compounded Formulations of Chlorambucil ...
The objective of this study was to further assess variability in potency and stability of compounded formulations of three commonly compounded oral chemotherapy ...
[91]
Over-the-Counter and Compounded Vitamin D: Is Potency What We ...
Feb 11, 2013 · In a recent trial examining vitamin D in menopausal women, we found that compounded vitamin D 3 (cholecalciferol) supplements varied significantly in potency.Missing: studies | Show results with:studies
[92]
Factors That Affect the Stability of Compounded Medications - PCCA
Mar 16, 2022 · USP 1191 discuses 11 factors that affect the stability of products. Of those 11, four factors are the most critical and common for compounded preparations.Missing: variability | Show results with:variability
[93]
Systematic evidence review of rates and burden of harm of ...
Dec 28, 2017 · Error types and reported rates varied substantially, including wrong drug (~0% to 4.7%), wrong diluent solution (0% to 49.0%), wrong label (0% ...
[94]
Dispensing error rates in pharmacy: A systematic review and meta ...
The worldwide prevalence of dispensing errors was 1.6% across community, hospital and other pharmacy settings.
[95]
Medication errors in community pharmacies: a systematic review of ...
Studies suggest around 1 in 100 medication errors results in an ADE, with 7 in 100 errors having the potential to cause actual patient harm [6]. In addition to ...
[96]
[PDF] Drug Compounding: Clear Authority and More Reliable Data ...
Jul 31, 2013 · To help ensure that the entities that compound drugs have appropriate oversight, Congress should consider clarifying FDA's authority to oversee.
[97]
Study: Compounding Pharmacy Oversight Inconsistent - WAMC
Aug 1, 2013 · ... oversight gaps. The report said that from 2002 to 2012, FDA officials had to obtain 11 warrants to inspect drug compounders' facilities that ...
[98]
[PDF] State Oversight of Drug Compounding - The Pew Charitable Trusts
Washington report requiring nonresident traditional pharmacies that perform sterile compounding ... compounding, including any oversight gaps or other issues that ...
[99]
Report: Limited FDA Survey of Compounded Drug Products
Jun 21, 2018 · Since 1990, FDA has become aware of more than 55 product quality problems associated with compounded products, many of which resulted in product ...Missing: statistics | Show results with:statistics
[100]
Exophiala Infection from Contaminated Injectable Steroids Prepared ...
Dec 13, 2002 · This report describes five cases of fungal infection associated with contaminated drugs prepared at a compounding pharmacy.
[101]
A multistate outbreak of Serratia marcescens bloodstream infection ...
Sep 1, 2007 · A multistate outbreak of S. marcescens bloodstream infection was linked to contaminated MgSO(4) distributed nationally by a compounding pharmacy.
[102]
Multistate Outbreak of Serratia marcescens Bloodstream Infections ...
Jul 13, 2009 · A multistate outbreak of Serratia marcescens bloodstream infection associated with contaminated intravenous magnesium sulfate from a compounding pharmacy.
[103]
Multistate Outbreak of Fungal Infection Associated with Injection of ...
Multistate outbreak of fungal infection associated with injection of Methylprednisolone Acetate solution from a single compounding pharmacy.
[104]
Fungal Infections Associated with Contaminated ...
Dec 19, 2012 · We present data on a multistate outbreak of fungal meningitis and other infections associated with injections of preservative-free methylprednisolone acetate
[105]
Multistate Outbreak of Fungal Meningitis and Other Infections | HAI
Oct 30, 2015 · On September 26, 2012, NECC voluntarily recalled three lots of preservative-free MPA associated with the multistate outbreak of fungal ...
[106]
Owner of New England Compounding Center Convicted of ...
Mar 22, 2017 · Barry Cadden, the owner and head pharmacist of New England Compounding Center (NECC), was convicted today by a federal jury of racketeering and mail fraud.
[107]
Multistate outbreak of fungal meningitis and other infections - FDA
Nov 1, 2016 · [12-12-2012] FDA and CDC have identified bacterial and/or fungal contamination in unopened vials of betamethasone, cardioplegia, and ...
[108]
FDA's Human Drug Compounding Progress Report: Three Years ...
In October 2012, the United States faced the most serious outbreak associated with contaminated compounded drugs in recent history. A pharmacy in Massachusetts ...
[109]
Mold findings spark NJ compounding pharmacy recall - CIDRAP
Mar 18, 2013 · Mar 18, 2013 (CIDRAP News) – A New Jersey compounding pharmacy yesterday recalled all of its products after a Connecticut hospital found ...
[110]
Texas pharmacy recalls products after infections - NBC News
Aug 11, 2013 · A Texas compounding pharmacy has recalled all its sterile products after 15 people who got calcium injections developed bacterial infections ...
[111]
Toward Better-Quality Compounded Drugs — An Update from the FDA
Dec 28, 2017 · The FDA has received reports of serious adverse events, including deaths, associated with improperly compounded drugs as recently as this year.Missing: timeline | Show results with:timeline
[112]
Content Analysis of US FDA Warning Letters Issued to ... - NIH
Nov 16, 2022 · The study was designed to critically assess FDA warning letters (WLs) issued to compounding pharmacies in 2017–2022 for violations of Current Good ...
[113]
Empower Pharmacy's FDA violations raise ... - Houston Chronicle
May 12, 2025 · Houston-based Empower Pharmacy has grown into a top compounding pharmacy in the nation despite a decade of documented regulatory violations.
[114]
Drug Quality and Security Act 113th Congress (2013-2014)
Requires the Secretary to: (1) publish a list of drugs presenting demonstrable difficulties for compounding that are reasonably likely to lead to an adverse ...
[115]
[PDF] The Drug Quality and Security Act of 2013: Compounding Consistently
The Drug Quality and Security Act (DQSA) of 2013 gave the FDA direct authority over large-scale compounding to prevent another national drug calamity.
[116]
Gaps in Regulation, Oversight, and Surveillance - NCBI - NIH
However, FDA does not have the regulatory authority to verify the safety or effectiveness of compounded drugs before they are marketed and dispensed to ...Missing: incidents post-
[117]
Compounding Inspections and Oversight Frequently Asked Questions
Apr 23, 2024 · FDA conducts surveillance, for-cause, and follow-up inspections of compounding facilities. 503A inspections check compliance, while 503B also ...What are the main differences... · How do I know if my FDA...
[118]
Compounding Pharmacies: The Real Story | Cedars-Sinai
May 22, 2025 · A compounding pharmacy creates customized medications that aren't available from traditional commercial pharmacies.
[119]
Harshbarger, Carter Introduce Legislation to Empower ...
Sep 12, 2025 · The Drug Shortage Compounding Patient Access Act of 2025 codifies long-standing FDA guidance allowing compounding of certain drugs during ...
[120]
What is a Compounding Pharmacy? FDA-Regulated 503A Vs 503B ...
Mar 29, 2024 · 503A pharmacies like Acacia, must follow FDA-USP regulatory standards that ensure the quality of the ingredients we use to make your compounds.
[121]
FDA Publishes Proposed Rule on 503A and 503B Compounding
Apr 5, 2024 · Under Section 503B, the drug product must be compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility ...
[122]
Compounding: Inspections, Recalls, and other Actions - FDA
Sep 18, 2025 · Inspections, recalls and other actions of compounders under section 503A and outsourcing facilities under section 503B.
[123]
Navigating the FDA's Final Interim Policy on Compounding with Bulk ...
Jan 22, 2025 · The FDA's interim policy signals a trend toward heightened regulatory scrutiny for both 503A traditional compounding pharmacies and 503B ...
[124]
Section 503A of the Federal Food, Drug, and Cosmetic Act - FDA
Jun 21, 2018 · --A drug may be compounded under subsection (a) only if the pharmacy, licensed pharmacist, or licensed physician does not advertise or promote ...Missing: traditional | Show results with:traditional
[125]
FD&C Act Provisions that Apply to Human Drug Compounding - FDA
Aug 13, 2021 · Sections 503A and 503B and Their Differences ; Patient-specific prescriptions. Compounding must be based on the receipt of a valid prescription ...
[126]
[PDF] Pharmacy Compounding of Human Drug Products Under Section ...
Section 503A regulates drug compounding by pharmacists/physicians, exempting them from some FD&C Act sections, and FDA intends to regulate these entities.Missing: assurance protocols
[127]
[PDF] Section 503A of the Food Drug & Cosmetic Act - ASHP
Sep 28, 2013 · In general, hospital and health systems will be subject to Section 503A. The bill also describes a new category of “outsourcing facilities” and ...
[128]
The Drug Quality and Security Act - PMC - NIH
Section 503A creates a “safe harbor” for traditional pharmacy compounding performed for a specific patient prescription and generally overseen by state boards ...
[129]
Information for Outsourcing Facilities - FDA
Mar 29, 2022 · Under section 503B, a compounder can become an outsourcing facility. The law defines an outsourcing facility as a facility at one geographic ...
[130]
History of 503B Outsourcing Facilities - Fagron Sterile Services
The FDA allows 503B outsourcing facilities to compound drug products using bulk drug substances that are established by the Secretary of the Department of ...
[131]
Current Good Manufacturing Practice—Guidance for Human Drug ...
Jan 7, 2021 · This revised draft guidance describes FDA's policies regarding compounders registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) ...
[132]
[PDF] Facility Definition Under Section 503B of the Federal Food, Drug ...
Section 503B(d) defines an outsourcing facility, in part, as “a facility at one geographic location or address.” FDA interprets “facility,” as used in this ...
[133]
Bulk Drug Substances Used in Compounding Under Section 503B
Jan 7, 2025 · Outsourcing facilities may not compound a drug product that includes a bulk drug substance unless the substance appears on FDA's 503B bulks ...
[134]
FDA Clarifies Prohibition on Wholesaling Under Section 503B of the ...
Jun 28, 2023 · Section 503B prohibits outsourcing facilities from wholesaling their products as one mechanism to preserve the integrity of the drug approval ...
[135]
Policy on Manufacturing and Compounding Drug Products in ...
Oct 26, 2020 · This policy framework covers drugs for human and veterinary use. This policy applies to all scheduled drugs regulated under the Food and Drugs Act.Scope · Background · Determination of Regulatory... · Policy Statement
[136]
Understanding Good Manufacturing Practice (GMP) for ...
May 1, 2017 · The purpose of this document is to clarify the PIC/S Guide to GMP for Medicinal Products PE-009 requirements for the manufacture of extemporaneously compounded ...
[137]
Good manufacturing practices guide for drug products (GUI-0001)
No person shall sell a drug that they have fabricated, packaged/labelled, tested or stored unless they have fabricated, packaged/labelled, tested or stored it ...
[138]
GMP information for manufacturers of compounded medicines and ...
Dec 1, 2017 · The Pharmacy Board of Australia Guidelines on compounding of medicines includes requirements in relation to batch preparation. In relation to ...
[139]
What you need to know about compounded weight-loss medicines
Jun 3, 2024 · Supplying compounded medicine without a prescription is illegal and these medicines may be fake or pose a significant risk to your health.Missing: pharmaceutical | Show results with:pharmaceutical
[140]
Compounding safety information: semaglutide-like products
Dec 15, 2023 · Pharmacists who compound medicines must follow guidelines from the Pharmacy Board to ensure the safety and quality of the products they compound ...
[141]
Model Standards for Pharmacy Compounding of Non-sterile ... - napra
NAPRA's suite of model standards for pharmacy compounding comprises three model standards, with one pertaining to non-hazardous sterile preparations.
[142]
[PDF] NON-STERILE PREPARATIONS
The NAPRA Model Standards for Pharmacy Compounding of Non-sterile Preparations and the accompanying Guidance. Document have been adapted from standards ...
[143]
[PDF] NON-HAZARDOUS STERILE PREPARATIONS - napra
The new NAPRA Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations have been adapted from standards originally developed by the Ordre ...
[144]
Model Standards for Pharmacy Compounding of Hazardous Sterile ...
NAPRA's suite of model standards for pharmacy compounding comprises three model standards, with one pertaining to non-hazardous sterile preparations.
[145]
Unauthorized compounding of semaglutide-containing products is ...
Jun 10, 2025 · Health Canada's position on the unauthorized manufacturing of products sold as compounded glucagon like peptide 1 (GLP-1) receptor agonists.
[146]
Implementing NAPRA's Model Standards for Pharmacy Compounding
Sep 30, 2020 · These model standards will set national standards for pharmacy compounding, once adopted by provincial/territorial pharmacy regulatory authorities.
[147]
Complying with the PIC/S Guide to Good Manufacturing Practice ...
Sep 1, 2025 · The PIC/S Guide to GMP for medicinal products applies to the manufacture of all medicines, active pharmaceutical ingredients and sunscreens.
[148]
Compounded medicines - Australian Prescriber
Jun 1, 2017 · To meet the Therapeutic Goods Administration (TGA) exemption, compounding must be for an individual patient (only stated in the conclusion) and cannot be in ' ...
[149]
[PDF] Guidelines on compounding of medicines - Ahpra
Oct 1, 2024 · This document may also be used as guidance to inform the compounding practices of pharmacists who are exempt from the requirement to hold a TGA ...
[150]
[PDF] Guidelines on compounding of medicines
Mar 1, 2015 · Pharmacists should document the preparation of compounded products in accordance with state, territory and Commonwealth legislation, practice.
[151]
Compounding Guidelines Update: Ensuring Safe Practices
The revised Guidelines on Compounding (August 2024) by the Pharmacy Board of Australia provide much-needed clarity and structure to compounding practices, ...
[152]
U.S. Compounding Pharmacies Market Size to Hit USD 10.76 Billion ...
Feb 20, 2025 · The adult segment holds the largest revenue share of over 44.18% in 2023. The segment growth is attributed to the rising awareness campaigns by ...Missing: community | Show results with:community
[153]
Compounding Pharmacy Market Size & Growth Forecast to 2030
Global Compounding Pharmacy market valued at $13.48B in 2024, $14.72B in 2025, and set to hit $19.41B by 2030, growing at 5.7% CAGR.
[154]
U.S. Compounding Pharmacies Market Size Report, 2030
The US compounding pharmacies market size was estimated at USD 5.13 billion in 2023 and is projected to grow at a CAGR of 4.89% from 2024 to 2030.
[155]
U.S. 503B Compounding Pharmacies Market Grows at 7.63% CAGR ...
Oct 1, 2025 · The U.S. 503B compounding pharmacies market size was estimated at US$ 1.08 billion in 2023 and is projected to grow US$ 2.25 billion by 2033.
[156]
U.S. 503B Compounding Pharmacies Market Shaping Sterile Drug ...
Sep 16, 2025 · The U.S. 503B compounding pharmacies market size is calculated at US$ 1.16 billion in 2024, grew to US$ 1.25 billion in 2025, and is projected ...
[157]
[PDF] An opportunity for pharmaceutical manufacturers - KPMG International
May 6, 2024 · The 503B legislation grew out of a need for greater regulatory oversight and patient safety standards within the compounding pharmacy market, ...<|separator|>
[158]
The Compounding Pharmacy Loophole Threatens Safety And ...
Oct 17, 2025 · Allowing compounding pharmacies to circumvent the intellectual property of innovative companies and sell potentially unsafe or less effective ...
[159]
Leveraging technology for smarter USP compliance in pharmacy IV ...
Sep 6, 2024 · Our pharmacy clinical experts explore the latest innovations that will equip modern compounding pharmacies with tools to keep up with the complexities of USP ...<|separator|>
[160]
The Future of Compounding Pharmacy: Top Trends and Innovations ...
Jan 6, 2025 · Discover the latest trends shaping compounding pharmacy, including automation, robotics, nanoencapsulation, strategic partnerships, ...
[161]
Exploring Innovative Approaches in Compounding Medicine
Innovative approaches such as precision dosing, novel drug delivery systems, combination therapies, and bio-identical hormone replacement therapy are ...
[162]
https://www.cdc.gov/hai/outbreaks/meningitis.html
[163]
Utilization and Costs of Compounded Medications for Commercially ...
The average ingredient cost for compounded medications increased by 130.3% from 2012 to 2013, from $308.49 to $710.36.
[164]
Food and Drug Administration Restrictions on Drug Compounding
There is an increased risk of noncompliance, of improper storage and handling, and decreased supply as some pharmacies have stopped providing some compounded ...
[165]
Examining Implementation Of The Compounding Quality Act - FDA
Jan 30, 2018 · We see the growth of the outsourcing facility sector as a critical feature to enable patients and providers to access higher-quality compounded ...
[166]
RIVA | Robotic IV Automation — ARxIUM | Innovative Pharmacy ...
RIVA™ is our fully automated IV compounding system for preparing syringes and IV bags, purpose-built to elevate the safety, accuracy + efficiency of your ...
[167]
Kiro Grifols – Kiro Grifols
A robotic system focused on precision, flexibility, reliability, and safety throughout the highly complex process of compounding oncology medications.Products · Kiro Grifols · Contact Us · KIRO Fill<|separator|>
[168]
Intravenous compounding robots in pharmacy intravenous ... - NIH
May 12, 2023 · Robotic compounding of mAbs is feasible, indicating it can be used to achieve reproducible high-quality compounding for delicate formulations. – ...
[169]
Exploring the Current State of Robotic Sterile Compounding – Part 1
May 14, 2025 · Sterile compounding robotics can be a beneficial component in pharmacy operations for enhancing both patient and staff safety while streamlining ...
[170]
Employing Compounding Robots to Enhance Efficiency, Safety
Dec 29, 2022 · An IV chemotherapy compounding robot within a large cancer center helped enhance treatment capacity, reduce technician workday stress, and improve compounding ...
[171]
Magistral Compounding with 3D Printing: A Promising Way to ... - NIH
Compounding using 3D printing in regular community pharmacies could enhance patients' individualized treatment; however, this activity would require incentives ...
[172]
Development and Bioequivalence of 3D‐Printed Medication at the ...
Feb 10, 2023 · The 3D printing of personalized formulations is a disruptive technology for compounding, bridging the gap toward personalized medicine.Study Highlights · Methods · Results
[173]
Automated 3D Printing-Based Non-Sterile Compounding ... - NIH
Jun 9, 2025 · This study explores the implementation of an automated compounding platform based on 3D printing to enhance precision, efficiency, and adaptability in ...
[174]
3D printing personalized medications in a hospital: Rapid and non ...
3D printing personalized medications ... personalised medicine and is a versatile production technology for compounding automation and decentralised manufacture.
[175]
Impact of technology-assisted versus manual sterile compounding ...
This study evaluated the impact of a technology-assisted workflow system (TAWS) on sterile compounding safety (checks, traceability, and error detection), and ...
[176]
Future Trends, Innovations And Predictions In Sterile Compounding
Robotic automation is poised to revolutionize sterile compounding processes. Automated systems can precisely measure, mix, and dispense medications, minimizing ...
[177]
Innovations In Sterile Compounding Equipment: Enhancing Safety ...
Innovations include automated compounding devices, robotic systems, advanced environmental monitoring, and closed system transfer devices (CSTDs).
[178]
[PDF] 2022 ISMP Guidelines for Sterile Compounding and the Safe Use of ...
The summit's objectives were four-fold: review current state of the use of technology and automation in compounding sterile preparations, examine sterile ...
[179]
Interim Policy on Compounding Using Bulk Drug Substances Under ...
Jan 7, 2025 · This guidance describes FDA's interim policy concerning compounding by human drug product compounders that are not outsourcing facilities using bulk drug ...
[180]
Human Drug Compounding Policies and Rules - FDA
1/6/2025, Final Guidance, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act ; 10/11/2024 ...Missing: ongoing debates pharmaceutical
[181]
Compounding: Key Policies and Advocacy | NCPA
FDA Guidances · Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act (January 2025).
[182]
Pharmacy Alert: FDA Issues Final Interim Guidances on ... - Frier Levitt
Jan 13, 2025 · On January 7, 2025, FDA released Guidances on compounding using bulk drug substances for both 503A pharmacies and 503B outsourcing facilities.
[183]
Tirzepatide, FDA, and Compounding: Understanding the Current ...
Jan 27, 2025 · Under FDA regulations, compounders may not compound medications that are “essentially copies” of commercially available drugs unless a shortage ...<|separator|>
[184]
6 things for healthcare stakeholders to know about GLP-1s and ...
Jul 16, 2025 · Lack of insurance coverage and high consumer drug costs for the originator products also fueled the high demand for compounded alternatives. 80 ...Missing: economic | Show results with:economic
[185]
FDA Unleashes Wave of Enforcement: The Industry Faces a ...
Sep 19, 2025 · The majority of the warning letters targeted compounding pharmacies and telehealth companies for misleading claims about compounded drugs, ...
[186]
Marketing and Safety Concerns for Compounded GLP-1 Receptor ...
Jan 17, 2025 · The FDA strictly regulates direct-to-consumer advertising for prescription medicines. However, compound pharmacies and their products fall into ...Missing: debates | Show results with:debates<|separator|>
[187]
Safety of Compounded Medications - PMC - NIH
Feb 5, 2025 · Compounded medications should be prescribed only when an FDA-approved medication cannot be used, and the benefits outweigh the risks.
[188]
Inter-governmental Working Meeting on Drug Compounding - FDA
May 30, 2025 · FDA virtually convened its 12th intergovernmental working meeting on drug compounding with state government officials on November 7 and 8, 2023.
[189]
FDA Issues Three Guidances on Pharmacy Compounding - ASHP
Although ASHP agrees with FDA's use of a prescription for an identified individual patient as a differentiator between pharmacy compounding and manufacturing, ...
[190]
Pharmaceutical Compounding: A US FDA Perspective - ISPE
Mar 4, 2025 · An in-depth look at the US FDA's perspective on drug compounding, its regulatory framework, and the significant events that have shaped current practices.
[191]
2023 Intergovernmental Meeting on Drug Compounding - FDA
May 30, 2025 · FDA announced in July 2024 that it intends to publish new guidance for outsourcing facilities on considerations related to drug shortages.