On June 13, 2024, Frier Levitt attorneys discussed some of the issues surrounding compounding GLP-1 agonists in a webinar titled, “Understanding FDA Regulations: Key Insights for 503A and 503B Compounding.” Since the webinar, FDA removed tirzepatide from the 506e shortage list on October 2, 2024. Notwithstanding, the concepts and topics covered in the webinar remain at the forefront of compounding because several GLP-1s remain on the Food and Drug Administration’s (“FDA”) 506e shortage list. The speakers addressed topics ranging from state laws and state Board of Pharmacy activity, regulatory considerations for various pharmacy business models including central fill arrangements and the six month experience with the USP 797/795 revisions. Below is a summary of key points from the webinar.
Federal compounding standards differ greatly between 503A and 503B compounding and accordingly there are different regulatory compliance issues that occur. For 503A compounding by pharmacies and pharmacists, Boards of Pharmacy inspect for USP 795 and 797 compliance and sometimes find issues regarding Certificates of Analysis (“COAs”), prohibited ‘office use’ compounding, anticipatory compounding in excessive amounts, and failure to adhere to Pharmacy policies and procedures, such as those which address out of specification compounding. 503A pharmacies cannot sell or distribute their compounds to other 503A or other than patients. One exception to 503A to 503A distribution may be a Central Fill arrangement. However, in instances where an exception may apply, it is crucial that pharmacies ensure strict compliance with any such exception under applicable state Board of Pharmacy rules and regulations which vary from state to state.
In contrast to 503A compounding, 503B outsourcing facilities are registered and inspected by the FDA using a different set of rules as they must follow cGMPs. Other differences include that 503B outsourcing facilities can compound large batches for “office use” and must also report adverse events. 503B outsourcing facilities are also required to be registered as a pharmacy if they are also compounding patient-specific prescriptions. Additionally, there are some prohibitions on resale and they are prohibited from engaging in wholesale activity. However, on June 27, 2023 the FDA issued draft Guidance stating that 503B outsourcing facilities could provide compounds to 503A community pharmacies for dispensing. Previously, this was only permitted for hospital purchasers.
Neither 503A pharmacies nor 503B outsourcing facilities can compound “essentially a copy” (there is an exception for the “essentially a copy” prohibition when a drug is on the 506e shortage list). The biggest question now is what happens when they are removed from the FDA shortage list. For those products including tirzepatide removed from the FDA shortage list and in “resolved” status, only a 503A will be permitted to compound them but pharmacies will not be permitted to compound “essentially a copy.” The supply from 503Bs will cease. Also, Eli Lilly indicated that it has issued cease-and-desist letters to compounding pharmacies, instructing them to stop compounding tirzepatide, claiming that all dosages are now available and cannot be compounded—even though the drug remains on the FDA’s shortage list.
Whether you are involved in 503A compounding, 503B outsourcing, or own a clinic or wellness spa, it is important to know the legal framework including all applicable laws, rules, and regulations governing these matters at both the federal and state level. Pharmacies should ensure they accurately understand all aspects of this complex area of the law and highly regulated industry. Pharmacies should always seek legal counsel and input to ensure they are accurate in their understanding and interpretation of these matters.
Frier Levitt’s webinar, which was previously presented live on June 13, 2024 can be viewed HERE.
This webinar is part of Frier Levitt’s 3-part series, “Mastering GLP-1 Compounding: Regulatory Insights, Business Strategies, Reimbursement, Telehealth, and Legal Considerations.” Access the entire 3-part webinar series HERE.
