503B Outsourcing Facility

With the passage of the Compounding Quality Act, Drug Quality and Security Act of 2013 FDA defined two categories of compounding pharmacies: 503A and 503B.

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Performance Validation has printed a limited number of Pocketbook compliance guides that include 21 CFR Part 210 and 211, and the FDA’s Compliance Policy Guide which addresses the FDA inspection methodology.

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Click here to jump to the USFDA Regulatory Policy Information page that lists all the compounding facility draft and final guidance documents.

503A Compounding Pharmacies

FDA anticipates that state boards of pharmacy will continue their oversight and regulation of the practice of pharmacy, including traditional pharmacy compounding under 503A.  These pharmacies are exempt from the following sections of the Food Drug and Cosmetic Act (FDCA):

  • Compliance with current good manufacturing practices (CGMP) (section 501(a)(2)(B));
  • Labeling with adequate directions for use (section 502(f)(1)); and
  • FDA approval prior to marketing (section 505).

503B Outsourcing Facilities

The Act creates a new section 503B in the FDCA by which a pharmacist can register the pharmacy as an “outsourcing facility”.  Under the Act, outsourcing facilities register with, and are regulated and inspected by FDA.  The benefits of registering as an outsourcing facility is that these facilities are not constrained by shipping restrictions and may compound drugs without obtaining an individual prescription for each drug.  A comparison of 503A and 503B can be found here.

An outsourcing facility will be able to qualify for exemptions from the FDA approval requirements and the requirement to label products with adequate directions for use, but not the exemption from CGMP requirements. Outsourcing facilities:

  • Must comply with CGMP requirements,
  • Will be inspected by FDA according to a risk-based schedule, and
  • Must meet certain other conditions, such as reporting adverse events and providing FDA with certain information about the products they compound.

503B Challenges

While there are obvious financial benefits to registering as a 503B facility, operating under cGMP is a new regulatory landscape that most pharmacists have never dealt with.  Thus they may not be aware of the regulatory requirements, the interpretation of the regulations, and how to prepare for the initial FDA inspection.  As listed on the FDA website, over 119 503B facilities received a Form 483 indicating conditions that in the judgement of the inspector may constitute violations of the Food Drug and Cosmetic (FD&C) Act .  Additionally, many pharmacies were not designed, qualified, or maintained to meet the cGMPs for finished pharmaceuticals and present an inspection observation just waiting to happen.

 

Performance Validation has over 25 years of operating in a cGMP regulated environment.  We can help you navigate the cGMP regulatory minefield and not only help you meet cGMPs but also help you understand them.  Contact us today for a consultation.

Our services include:

  • Audit / Consultation
    • Pre-registration consultation (cGMP scope determination).
    • Mock-audit to review documentation, exercise the “war room” and provide training to the staff
    • FDA Form 483 remediation (i.e., I just got audited and received my Form 483 – what do I do next?)
  • Training
    • Basic cGMPs
    • Aseptic techniques
    • Maintenance, calibration, and facility related issues
    • Quality System, development, trending, analysis of data
  • Standard Operating Procedures
    • Standard Operating Procedure development
    • Maintenance procedure development
    • Quality System development
  • Commissioning, Qualification, and Validation (CQV)
    • Master Plan (verification, commissioning, validation, project plan) development & implementation
    • Risk Management
    • Requirements & Specifications development
    • Design Qualification/Enhanced Design Review
    • Review of vendor provided CQV protocols
    • Development and/or execution of CQV protocols
    • Summary development, and overall Validation Plan report.