Under FDA guidance, the agency does not consider a compounded version of an FDA-approved drug “essentially a copy” of a commercially available drug when the FDA-approved drug is listed as “currently in shortage” on the FDA drug shortage webpage. This exception is essential for continuation of patient care when a drug is in shortage – as, amid continuing post-COVID supply chain issues, many are from time to time.
But what about compounded sublingual semaglutide – a dosage form that does not exist in FDA-approved form? Let’s remember the rules.
FDA’s Guidance for Industry titled “Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act” provides three criteria for determining whether a human compounded medication is a copy of a commercially available drug product:
- The compounded preparation has the same API as the commercially available drug product;
- The API has the same, similar, or an easily substitutable dosage strength; and
- The commercially available drug product can be used by the same route of administration as prescribed for the compounded drug.
When compounding doses not within 10 percent of the dosages offered by the commercially available product, a drug product does not meet the second criteria of the FDA guidance and is therefore not considered essentially a copy.
Compounding pharmacists must keep this criteria in mind when choosing to compound and market certain drug products.
Recently, pursuant to a prescription, some compounding pharmacies have begun offering a compounded sublingual version of semaglutide using Rybelsus tablets (the FDA-approved oral semaglutide medication) as the source of the API. The commercially available drug product is not indicated for and cannot be used via the sublingual route of administration (and therefore does not meet the third criteria in the FDA guidance). As a result, this should not be considered a copy of the FDA-approved drug.
Take care to consult the criteria listed in the FDA guidance and use precise language – in this case, sublingual, not oral – when marketing compounded drug products to clearly differentiate the compound from the commercially available product.
— Scott
Scott Brunner, CAE, is APC’s chief executive officer. You can reach him at scott@a4pc.org.
|