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 record since December 2022. Though all accessible strengths of Lilly’s tirzepatide merchandise Zepbound and Mounjaro have been listed as “accessible” since August 2, 2024, it has taken FDA a further two months to find out that there’s adequate provide to permit elimination from the drug scarcity record. After eradicating it from the drug scarcity record, 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 by means of the availability 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 steering, a compounded drug can’t be “primarily a duplicate of an authorized drug,” until it meets an exemption (e.g., showing on the drug scarcity record). Basically a duplicate means:
- A drug that’s “an identical or almost an identical” to an authorized drug, until the drug seems on the drug scarcity record; or
- A drug, a part of which is a bulk drug substance (i.e., energetic pharmaceutical ingredient) that may be a part of an authorized 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 authorized 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 Basically Copies of Accredited Drug Merchandise Beneath Part 503B of the Federal Meals, Drug, and Beauty Act” steering states the next:
FDA doesn’t intend to take motion in opposition to an outsourcing facility for filling orders that it obtained for a compounded drug that’s an identical, or almost an identical, to an authorized drug that was on FDA’s drug scarcity record on the time that the outsourcing facility obtained the order, supplied the drug additionally appeared on the FDA drug scarcity record inside 60 days of the outsourcing facility distributing or meting out the drug….
FDA could take regulatory motion, nonetheless, if an outsourcing facility continues to fill new orders for the compounded drug after the authorized drug is faraway from FDA’s drug scarcity record, or if it continues to fill orders greater than 60 days after the drug has been faraway from FDA’s drug scarcity record.
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 medication.”
This language means that FDA, in conjunction of with state Boards of Pharmacy could pursue enforcement motion in opposition to compounders that proceed to compound with this ingredient and probably associated combos outdoors of the steering and exemptions famous above.
Key Takeaways:
- As of October 2, 2024, Lilly’s tirzepatide, the energetic 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 authorized product until it seems on the drug scarcity record.
- Beneath present FDA steering for 503B pharmacies, they’re not permitted to just accept new orders for tirzepatide which are primarily copies of the Lilly product. They’re permitted to dispense orders that have 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 medication.
- Provided that the scarcity of tirzepatide has been resolved and FDA’s reminder of what may be legally compounded, this implies potential enforcement sooner or later for continued compounding of tirzepatide and combos.
We’ll proceed to watch this case very carefully. Foley is right here that will help you tackle the brief and long-term impacts within the wake of regulatory modifications. We now have the assets that will help you navigate these and different necessary authorized issues associated to enterprise operations and industry-specific points. Please attain out to the authors, your Foley relationship companion, or to our Well being Care Follow 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 Record appeared first on Foley & Lardner LLP.