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) remedy, has been “resolved”. The tirzepatide injection had appeared on FDA’s drug scarcity listing since December 2022. Though all obtainable strengths of Lilly’s tirzepatide merchandise Zepbound and Mounjaro have been listed as “obtainable” since August 2, 2024, it has taken FDA a further two months to find out that there’s enough provide to permit elimination 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 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.”
Beneath present FDA steerage, a compounded drug can’t be “primarily a duplicate of an authorised drug,” until it meets an exemption (e.g., showing on the drug scarcity listing). Primarily a duplicate means:
- A drug that’s “similar or almost similar” to an authorised drug, until 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, until “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 acquired, 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 Authorized Drug Merchandise Beneath Part 503B of the Federal Meals, Drug, and Beauty Act” steerage states the next:
FDA doesn’t intend to take motion towards an outsourcing facility for filling orders that it acquired for a compounded drug that’s similar, or almost similar, to an authorised drug that was on FDA’s drug scarcity listing on the time that the outsourcing facility acquired 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 might take regulatory motion, nonetheless, 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 attainable 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 medication.”
This language means that FDA, in conjunction of with state Boards of Pharmacy might pursue enforcement motion towards compounders that proceed to compound with this ingredient and probably associated mixtures outdoors of the steerage 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 duplicate” of an authorised product until it seems on the drug scarcity listing.
- Beneath present FDA steerage for 503B pharmacies, they’re not permitted to simply accept new orders for tirzepatide which can be primarily copies of the Lilly product. They’re permitted to dispense orders that have been acquired 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 medication.
- Provided that the scarcity of tirzepatide has been resolved and FDA’s reminder of what may be legally compounded, this means attainable enforcement sooner or later for continued compounding of tirzepatide and mixtures.
We’ll proceed to watch this case very intently. Foley is right here that will help you tackle the quick and long-term impacts within the wake of regulatory adjustments. We now have the assets that will help you navigate these and different necessary authorized concerns associated to enterprise operations and industry-specific points. Please attain out to the authors, your Foley relationship associate, or to our Well being Care Observe Group and Well being Care & Life Sciences Sector with any questions.
The put up GLP-1 Medicine: FDA Removes Lilly’s Zepbound® and Mounjaro® (tirzepatide injection) from its Drug Scarcity Record appeared first on Foley & Lardner LLP.
