503a OR 503b

In the U.S., compounding pharmacies are regulated primarily by state boards of pharmacy, which often collaborate with federal agencies such as the Drug Enforcement Administration or the Department of Health and Human Services. Other organizations, such as the U.S. Food and Drug Administration, the Occupat ional Safety and Health Administration, the Environmental Protection Agency, and state departments of agriculture or labor may also have jurisdiction over compounding pharmacies and their employees...

OBJECTIVE: The purpose of this commentary is to describe the ideal role of 503B outsourcing facilities in the U.S. drug supply chain. We also address the challenges that 503B outsourcing facilities are facing that limit their utilization and offer possible solutions. SUMMARY: Section 503B outsourcing facilities are emerging contributors in compounding owing to their ability to compound large quantities of medication without requiring patient-specific prescriptions...

The purpose of this commentary is to describe the differences between 503A and 503B facilities and the policies and restrictions for compounding from bulk drug substances. Due to the 2012 meningitis outbreak linked to compounded steroid injections, the landscape of pharmacy compounding was changed in the United States. This event led to the creation of two distinct types of compounding pharmacies, 503A and 503B facilities. 503B facilities are restricted from compounding using bulk drug substances unless they are on the Food and Drug Administration drug shortage list or appear on the 503B Bulk Drug Substance list...

PURPOSE: The coronavirus disease 2019 (COVID-19) pandemic has created unprecedented challenges for health systems around the world. We describe our approach to adapting the pharmacy leadership structure to address critical medication shortages through innovative data analysis, procurement strategies, and rapid implementation of medication policy. SUMMARY: Yale New Haven Health deployed a system incident management command structure to effectively respond to the COVID-19 crisis...

The U.S. Food and Drug Administration regulates outsourcing facilities with the same stringency they apply towards drug manufacturers. This means that outsourcing facilities, who must navigate the changing regulatory landscape to achieve and maintain 503B status, must now focus on qualifying container closure systems for their intended use. This article, the second in a two-part series, examines component selection and methods for demonstrating that the container closure system will protect and maintain the quality of the compounded drug and ensure that the compounded drug can be safely administered to a patient...

The U.S. Food and Drug Administration regulates outsourcing facilities with the same stringency they apply towards drug manufacturers. This means that outsourcing facilities, who must navigate the changing regulatory landscape to achieve and maintain 503B status, need to focus on qualifying container closure systems for their intended use. Container closure systems must be fit-for-purpose (i.e., suitable for in-use conditions relative to drug product stability over intended shelf-life and storage conditions)...

FDA guidance on outsourcing facilities and 503A pharmacies.

Changes in California regulations regarding beyond-use dates of sterile preparations have prompted many compounders to consider stability studies for their formulas. Traditionally, 503A compounders have relied on published data and professional experience to determine stability. However, due to these new regulations, stability studies are now required for California resident and nonresident licensees to extend the beyond-use date of sterile preparations. Conducting studies for the first time can be costly and difficult for compounding pharmacists...

The first recorded mention of a pharmacogenomic response may be that of Pythagoras in 510 BC, when he noted that hemolytic anemia developed in some but not all people who ingested fava beans. The application of such accounts to pharmacotherapy was inevitable, and customized medications have been compounded since antiquity to treat the needs of individual patients. Today, advances in pharmacogenomic testing yield results that enable more effective targeted therapies sooner in the course of treatment, prevent drug-related adverse effects, save cost, and ensure a better therapeutic outcome...

The terms certification, accreditation, and credentialing are often used interchangeably when they apply to compounding-pharmacy qualifications, but they are not synonymous. The reasons for obtaining each, the requirements for each, and the benefits of each differ. Achieving such distinctions can negatively or positively affect the status of a pharmacy among peers and prescribers as well as a pharmacy's relationships with third-party payors. Changes in the third-party payor industry evolve constantly and, we suggest, will continue to do so...

This article deals with documentation to include the beginning of documentation, the requirements of Good Manufacturing Practice reports and records, and the steps that can be taken to minimize Good Manufacturing Practice documentation problems. It is important to remember that documentation for 503a compounding involves the Formulation Record, Compounding Record, Standard Operating Procedures, Safety Data Sheets, etc. For 503b outsourcing facilities, compliance with Current Good Manufacturing Practices is required, so this article is applicable to them...

Compounding pharmacists must ensure that the sterile preparations they dispense are free of microbiologic contamination. Working in a cleanroom under controlled conditions (proper differential air pressure, temperature, and humidity; acceptable levels of viable and nonviable airborne particles and surface counts, etc.) and testing the efficacy of cleaning and disinfecting practices via environmental monitoring (viable-air and surface testing, glove-fingertip-thumb testing, etc.) are essential to preparing contamination-free medications...

This is a randomized, double-blind, single-dose, parallel group phase 1 study to assess pharmacokinetic similarity, safety, and tolerability of BS-503a, a proposed bevacizumab biosimilar. A total of 114 male healthy subjects were randomized (1:1) to receive a single 3 mg/kg intravenous dose of either BS-503a or bevacizumab (Avastin(®)). Pharmacokinetic (PK) blood samples were collected up to Day 78, and serum drug concentrations were measured using a validated enzyme-linked immunosorbent assay. Pharmacokinetic similarity was evaluated using area under the serum concentration-time curve from zero to infinity (AUC inf) as a primary PK parameter, and maximum serum concentration (Cmax) and area under the serum concentration-time curve from zero to the last measurable time (AUC last) as secondary PK parameters...

The reasons for which pharmaceutical compounding is the focus of intense state and federal scrutiny are now well known. Compounders are faced with an ever-increasing need to prove, by objective standards, the safety, purity, and potency of the formulations they dispense. They must also demonstrate their compliance with regulations often based on current good compounding practices designed for the pharmaceutical industry. In the U.S. today, rigorous unannounced state and federal inspections of compounding facilities are occurring more and more frequently...

Equipment systems that enable compliance with stringent state and federal compounding requirements are a topic of increasing interest to U.S. pharmacists. Of those equipment types, an aseptic vial processing line offers unique benefits (especially to 503B compounding pharmacies and small contract manufacturers of aseptic pilot-size batches) if the volume of sterile preparations dispensed offsets the cost of purchase, installation, and maintenance. In this article, the reasons for and the process of selecting an aseptic vial processing line for use in 2 independent 503B compounding pharmacies are presented, the operation of our choice of equipment is described, and specifications for the components of that line are listed...

Mutations in keratin 5 (KRT5) or KRT14 genes are responsible for the most severe form of epidermolysis bullosa simplex (EBS), which is EBS generalized severe (EBS-gen sev). To date, only four pathogenic mutations (p.Arg165Ser and p.Lys199Asn in KRT5; p.Arg125Cys and p.Arg125His in KRT14) have been reported to be responsible for EBS-gen sev in the Chinese population. In the present study, a 2-year-old Chinese boy was clinically suspected to suffer from EBS, and thus Sanger sequencing was performed in the extracted genomic DNA samples from the patient, his parents and 100 healthy controls...

The Food and Drug Administration (FDA or the Agency) is amending its regulations to revise the list of drug products that have been withdrawn or removed from the market because the drug products or components of such drug products have been found to be unsafe or not effective. Drugs appearing on this list may not be compounded under the exemptions provided by sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). Specifically, the rule adds 24 entries to this list of drug products, modifies the description of one entry on this list, and revises the list's title and introductory language...

Performance improvement is the continual effort to objectively assess current performance and then restructure the practices that support it to more closely achieve desired performance. A plan for performance improvement, unlike other approaches to correcting problems in job fulfillment, is a systematic method used to first find the root causes of areas of concern and then apply corrections to remedy those deficits. Implementing a performance improvement plan that can be easily adapted to ensure compliance with evolving and increasingly complex state and federal regulations is crucial to a successful compounding practice...

A high-level assessment of recent U.S. Food and Drug Administration audits of 503A facilities indicates that a regulatory paradigm shift is occurring. Data and rationale further indicates that the agency seems to be taking a proactive approach for how it monitors these facilities. The auditing practices and observations are eerily similar to those which are seen for 503B Outsourcing Facilities, as well as Current Good Manufacturing Practices Drug and Device Manufacture plants. Perhaps the U.S. Food and Drug Administration is attempting to avoid any major medical outbreaks that may stem from under-supervised drug preparation centers...

OBJECTIVE: We review the historical regulation of drug compounding, concerns about widespread use of non-Food and Drug Admiistration (FDA)-approved compounded bioidentical hormone therapies (CBHTs), which do not have proper labeling and warnings, and anticipated impact of the 2013 Drug Quality and Security Act (DQSA) on compounding. METHODS: US government websites were searched for documents concerning drug compounding regulation and oversight from 1938 (passage of Federal Food, Drug, and Cosmetic Act [FDCA]) through 2014, including chronologies, Congressional testimony, FDA guidelines and enforcements, and reports...