With the resolution of the shortage for the drug, Tirzepatide, marketed as Mounjaro® for diabetes and Zepbound® for weight management, 503A pharmacies and 503B facilities need to remain vigilant of FDA and state rules/regulations as it relates to restrictions on compounding and/or dispensing compounded Tirzepatide.
Once a drug is off the FDA shortage list, it can only be compounded by 503A pharmacies under a narrow set of circumstances and definitely cannot compound “essentially a copy”. A change to the product that produces a ‘significant difference’ for an individual patient between the compounded drug and the comparable approved drug, as determined by the prescribing practitioner must be documented. The FDA considers a medical necessity as a change made for an individual patient that produces a significant difference for that patient. To meet the requirements for medical necessity, the pharmacy must maintain specific documentation. Retention of that documentation is proscribed in both FDA and state pharmacy rules.
Regarding compounding by 503B outsourcing facilities, the FDA understands that an outsourcing facility may not be able to predict when a drug shortage will be resolved. As such, the FDA provides flexibility when an outsourcing facility such as a 503B entity fills orders that it received for a compounded drug while the drug was in shortage. However, the FDA may take action if a 503B entity continues to fill new orders after the drug is removed from FDA’s shortage list, or if it continues to fill existing orders more than 60 days after the drug has been removed from FDA’s shortage lists. Beyond the 60-day period, a 503B may not compound Tirzepatide, even if it for the purpose of supplying the drug to a 503A pharmacy.
It is not unusual for drugs taken off the 506e shortage list to be placed back on the list. As the FDA begins to receive complaints from prescribers, patients and pharmacists that they cannot obtain the brand product and/or if patient therapy disruptions begin to emerge, the FDA may place Tirzepatide back on the shortage list.
How Frier Levitt Can Assist:
In light of this FDA update, there may be some be some difficulty in navigating FDA and state rules/regulations for compounding when a drug is removed from the FDA shortage list. Frier Levitt has experience in representing both 503A compounding pharmacies and 503B outsourcing facilities in these matters. We regularly counsel clients 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.
