FDA's Guidance on Compounding for Human Use

As discussed previously on the Baer Law Blog, Title I of the Drug Quality and Security Act (DQSA) gives the Food and Drug Administration (FDA) new powers to oversee drug compounding. Section 503A of the DQSA sets out certain requirements for traditional compounding, while Section 503B creates a new entity called outsourcing facilities.

This blog provides a brief review of the most recent documents released by the FDA which include policies and proposals regarding traditional compounding pharmacies and outsourcing facilities that compound drugs for human use.

The five documents are:

  1. Draft Interim Guidance. Sets forth the FDA’s thinking as to its expectations for outsourcing facilities regarding compliance with Current Good Manufacturing Practices (CGMP) until regulations are developed. The guidance focuses on the CGMP requirements that relate to sterility assurance and safety of compounded drug products. CGMP expectations include but are not limited to:
    • Facility design, including air quality requirements for sterile drugs;
    • Control systems requiring separate or defined areas for facility operations to prevent contamination;
    • Systems for environmental and personnel monitoring in aseptic processing areas;
    • Controls over equipment used to compound;
    • Control over source and quality components;
    • Laboratory controls for testing components and finished drug products;
    • A program for stability and expiration dating; and
    • Packaging requirements for sterile drugs.
  2. A Proposed Rule.
    • Adds twenty-five new drug products to the do-not-compound list.
    • FDA intends to prohibit all drug products for a certain molecule.
  3. Final Guidance.  FDA’s current thinking on the enforcement of Section 503A
    • FDA’s position on when it will begin to enforce the five percent (5%) limit on out-of-state distribution for pharmacies located in states that have not entered into the Memorandum of Understanding (MOU).
    • FDA is currently working with the National Association of Boards of Pharmacy (NABP) on the MOU to address interstate distribution of compounded drugs.
  4. 503A of the Drug Quality and Security Act (DQSA).
    • Exempts state-licensed pharmacies and federal facilities from the Food, Drug and Cosmetic Act (FDCA) new drug approval, CGMP, and certain labeling requirements.
    • Intended for smaller traditional compounding operations that compound in response to patient specific prescriptions and are engaged in minimal out of state distribution.
  5. 503B of the DQSA.  
    • Exempts sterile outsourcing facilities from the FDCA new drug approval requirements, as well as some labeling and drug distribution requirements.
    • Outsourcing facilities are subject to the CGMP requirements and can only compound drug substances that are on a clinical need list established by the FDA.
    • Outsourcing facilities can distribute out of state without limitation and can compound large quantities of products on the FDA’s drug shortage list without prescriptions.

The documents and proposals are the latest action by the FDA under its new authority. Traditional compounders and outsourcing facilities should make every attempt to remain current on these issues. Contact Baer Law with any questions.