Over the past week, dozens of our clients have sought clarification of whether or not they may compound tirzepatide or any drug for that matter, that is removed from the Food & Drug Administration (FDA) 506e shortage list and placed into ‘resolved’ status. While there are certain narrow circumstances under which drugs in ‘resolved status’ may still be compounded, this is an individual inquiry and formal legal advice is necessary.
From recent industry announcements, it appears that the resolution of the shortage of the GLP-1 Agonist, tirzepatide, may be imminent. However, a drug can only be removed from the shortage list and receive a ‘resolved’ status when the FDA Drug Shortage Staff determines that the supply can cover the total market. As of today, August 5, 2024, both tirzepatide and semaglutide remain on the FDA 506e shortage list. Once either of these medications is removed from the list by the FDA, additional restrictions will be placed on their compounding.
According to FDA Guidance, neither a 503A nor a 503B facility will be permitted to compound ‘essentially a copy’ of the commercially available drug product. For a 503B outsourcing facility, there is a sixty (60) day grace period for compounds ‘on order’ or ‘in process’ (e.g., undergoing batch testing). The purpose of this grace period is to prevent disruptions in patient care, and to ensure that already compounded product is not wasted. FDA has indicated it will exercise enforcement discretion during that grace period. After the grace period, the 503B will not be able to compound the drug, even if it is compounding to sell to a 503A which then dispenses to its patients. A 503B which is also registered as a 503A pharmacy may be able to compound pursuant to the 503A rules, again under certain very specific circumstances.
According to FDA Guidance, there is no grace period for 503A pharmacy compounders. As we all know, 503A pharmacies may only compound patient-specific prescriptions. Such compounding would still be permitted even if the drug is in ‘resolved’ status, if there is a medical need for an individual patient that cannot be met by the commercially available drug (CAD). The compounding would need to follow FDA’s Guidance entitled “Compounded Drug Products That Are Essentially Copies of Commercially Available Drug Product Under Section 503A of the Federal Food, Drug and Cosmetic Act”.[1] Once off the shortage list, a 503A cannot compound ‘essentially a copy’ and ‘regularly and in inordinate amounts’, but compounders will need to understand the specific circumstances involved.
When a drug is in ‘resolved’ status and a prescriber documents ‘significant difference’ (as explicitly defined in the Guidance), and documents this on the prescription, the drug may be compounded within specific scenarios. The reason cannot be a pretext, for example, where physicians are receiving incentives to write compounded prescriptions. Nor can the ‘significant difference’ be solely based on ‘lower price.’ No particular format for the documentation is required, but if the reason (i.e. difference) is omitted or unclear, the pharmacist must contact the prescriber and make a notation on the prescription which includes the date of the conversation. In the FDA Guidance, FDA has indicated it will not question the prescriber’s determination.
How Frier Levitt Can Help
It is difficult to understand the rules for compounding when a drug status goes from ‘in shortage’ to ‘resolved’ status. At the same time, it is easy for a compounder to run afoul of the complicated ‘essentially a copy’ rules.
We represent both 503B outsourcing facilities and numerous 503A pharmacy compounders and regularly counsel on Section 503A and state-specific compounding requirements, assess compounding practices for state and federal regulatory compliance, including USP 797/795/800, medical necessity documentation, advertising, promotion, reimbursement issues, infrastructure, and preparing compounding policies and procedures that provide clear guidelines, standards and training for staff. Contact us to discuss your specific needs.
[1] FDA Guidance. Jan 2018.
