FDA Publishes Temporary Policy on Compounding of Drugs

FDA issued a guidance document on April 16, 2020 explaining the agency’s temporary policy for the compounding of drugs for hospitalized patients by outsourcing facilities that have registered with FDA under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353b). The temporary policy is part of FDA’s actions in response to the COVID-19 pandemic and will “remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (42 U.S.C. 247d(a)(2)).”

The guidance states that FDA will not take action against “an outsourcing facility for compounding a drug product that is essentially a copy of an approved drug, for using a bulk drug substance that is not on FDA’s 503B Bulks List, or for not meeting current good manufacturing practice (CGMP) requirements with regard to product stability testing and the establishment of an expiration date, when all of the following circumstances are present:

• The compounded drug product appears on the list in Appendix A of drugs used for hospitalized patients with COVID-19 and contains only one of the active ingredients listed there.

• The compounded drug product is provided directly to a hospital that informs the outsourcing facility it (i) is treating patients with COVID-19, and (ii) has made reasonable attempts to obtain an FDA-approved drug product containing the same active ingredient for the same route of administration and has been unable to do so.

• Bulk drug substances that the outsourcing facility uses to compound the drug product are in compliance with section 503B(a)(2)(B) through (D) of the FD&C Act (21 U.S.C. 353b(a)(2)(B) through (D)), regarding conformance with applicable United States Pharmacopeia (USP) monograph standards, sourcing from facilities registered with FDA under section 510 of the FD&C Act (21 U.S.C. 360), and certificates of analysis.

• The outsourcing facility’s practices regarding stability testing and expiration dates meet the conditions for enforcement discretion described in Appendix B to this guidance (Stability/Expiration Dating For Compounded Drug Products) and Appendix C to this guidance (Conditions Under which FDA Generally Does Not Intend to Take Regulatory Action Regarding Stability Testing and Expiration Date Requirements), except that:
• If the compounded drug product is an aqueous sterile solution for injection and all ingredients are readily soluble in water:
• The outsourcing facility uses a default beyond-use date (BUD) of not more than 28 days at room temperature and not more than 42 days refrigerated when a sterility test has not been completed before release.

• The outsourcing facility initiates limited stability testing before the aggregate batch size of the product exceeds 1000 units.

• If the compounded, finished drug product is not intended or expected to be sterile:
• The outsourcing facility uses the default BUDs in Table B of Appendix C of this guidance.

• The outsourcing facility initiates limited stability testing before the aggregate batch size exceeds 5000 units.

• The outsourcing facility uses a shorter BUD than those described or referenced above if literature or other scientific information, including relevant commercially available product labeling for a similar drug (e.g., components, dosage form, route of administration, primary container-closure type), indicates that the drug product may not be physicochemically stable for the duration of the default BUD period.”

While the guidance is being implemented immediately, it is still subject to comment.

Source: FDA