On October 2, 2024, the U.S. Meals and Drug Administration (FDA) decided the scarcity of the tirzepatide injection, a glucagon-like peptide 1 (GLP-1) treatment, has been “resolved”. The tirzepatide injection had appeared on FDA’s drug scarcity listing since December 2022. Though all out there strengths of Lilly’s tirzepatide merchandise Zepbound and Mounjaro have been listed as “out there” since August 2, 2024, it has taken FDA a further two months to find out that there’s enough provide to permit removing from the drug scarcity listing. After eradicating it from the drug scarcity listing, FDA said the next:
FDA confirmed with the drug’s producer that their said product availability and manufacturing capability can meet the current and projected nationwide demand. Sufferers and prescribers should still see intermittent localized provide disruptions because the merchandise transfer via the provision chain from the producer and distributors to native pharmacies.
See FDA’s press launch “FDA clarifies insurance policies for compounders as nationwide GLP-1 provide begins to stabilize.”
Below present FDA steering, a compounded drug can’t be “primarily a replica of an authorised drug,” except it meets an exemption (e.g., showing on the drug scarcity listing). Primarily a replica means:
- A drug that’s “an identical or almost an identical” to an authorised drug, except the drug seems on the drug scarcity listing; or
- A drug, a part of which is a bulk drug substance (i.e., lively pharmaceutical ingredient) that may be a part of an authorised drug, except “there’s a change that produces for an particular person affected person a medical distinction, as decided by the prescribing practitioner, between the compounded drug and the comparable authorised drug.” See Part 503B(d)(2)(A)-(B) (codified at 21 U.S.C. § 353b(d)(2)(A)-(B)).
Following the decision of a drug scarcity, a 503B facility has 60 days to dispense any orders it has already obtained, however the facility should cease taking new orders as soon as the drug scarcity is listed as “resolved.” FDA’s “Compounded Drug Merchandise That Are Primarily Copies of Authorised Drug Merchandise Below Part 503B of the Federal Meals, Drug, and Beauty Act” steering states the next:
FDA doesn’t intend to take motion towards an outsourcing facility for filling orders that it obtained for a compounded drug that’s an identical, or almost an identical, to an authorised drug that was on FDA’s drug scarcity listing on the time that the outsourcing facility obtained the order, offered the drug additionally appeared on the FDA drug scarcity listing inside 60 days of the outsourcing facility distributing or shelling out the drug….
FDA could take regulatory motion, nevertheless, if an outsourcing facility continues to fill new orders for the compounded drug after the authorised drug is faraway from FDA’s drug scarcity listing, or if it continues to fill orders greater than 60 days after the drug has been faraway from FDA’s drug scarcity listing.
With respect to potential enforcement of this coverage, in FDA’s press launch “FDA clarifies insurance policies for compounders as nationwide GLP-1 provide begins to stabilize” issued on October 2, FDA said: “FDA reminds compounders of the authorized restrictions on making copies of FDA-approved medicine.”
This language means that FDA, in conjunction of with state Boards of Pharmacy could pursue enforcement motion towards compounders that proceed to compound with this ingredient and presumably associated mixtures exterior of the steering and exemptions famous above.
Key Takeaways:
- As of October 2, 2024, Lilly’s tirzepatide, the lively ingredient in each Zepbound® and Mounjaro® was faraway from FDA’s Drug Scarcity database and listed as “resolved”.
- FDA doesn’t allow the compounding of a product that’s “primarily a replica” of an authorised product except it seems on the drug scarcity listing.
- Below present FDA steering for 503B pharmacies, they’re not permitted to just accept new orders for tirzepatide which might be primarily copies of the Lilly product. They’re permitted to dispense orders that had been obtained earlier than the scarcity resolved for the subsequent 60 days.
- In a press launch issued by FDA on October 2, the company said: FDA reminds compounders of the authorized restrictions on making copies of FDA-approved medicine.
- On condition that the scarcity of tirzepatide has been resolved and FDA’s reminder of what may be legally compounded, this means potential enforcement sooner or later for continued compounding of tirzepatide and mixtures.
We’ll proceed to watch this example very carefully. Foley is right here that will help you deal with the brief and long-term impacts within the wake of regulatory modifications. We’ve got the assets that will help you navigate these and different essential authorized issues associated to enterprise operations and industry-specific points. Please attain out to the authors, your Foley relationship accomplice, or to our Well being Care Observe Group and Well being Care & Life Sciences Sector with any questions.
The put up GLP-1 Medication: FDA Removes Lilly’s Zepbound® and Mounjaro® (tirzepatide injection) from its Drug Scarcity Checklist appeared first on Foley & Lardner LLP.