Drug Shortages and Human Drug Compounding - a quick review.

Effective 02/21/25, semaglutide (Ozempic and Wegovy) drug shortage is finally resolved since its declaration of shortage since August 2022 especially when there had been an increase demand of weight loss use exceeding the supplies (FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize | FDA). In other words, compounders (503A and 503B) will have a certain off-ramp time to compound before they are no longer allowed by FDA to compound as drug companies resume manufacturing. Compounders do play an important role in filling in the drug shortage gap when drug manufacturers cannot keep up with demand and/or when they face other challenges such as CGMP violations.

It is important to note that compounded drugs are not FDA-approved and must follow certain regulations such as:

• 503A compounding pharmacy (i.e. hospital pharmacy, small compounding pharmacy, or clinics): makes individualized medication based on written prescriptions and does NOT have to follow CGMP but rather USP <797> for sterile human compounding activities (Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance)

• 503B outsourcing facility (almost like a manufacturer but without filing for a drug application if they make copies of FDA approved drugs): can compound drugs without individualized prescriptions and has to follow CGMP (Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry)

• FDA does enforce what's called "insanitary conditions" under the FD&C Act Section 501(a)(2)(A) where a drug is deemed to be adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may become contaminated with filth or rendered injurious to health regardless of a facility is 503A or B - this is an umbrella approach to catch bad compounders if they fail to meet 503A/B sections.

For semaglutide, there were dosing errors associated with compounded drugs (FDA alerts health care providers, compounders and patients of dosing errors associated with compounded injectable semaglutide products | FDA). To learn more about human drug compounding, you can read my article https://www.linkedin.com/posts/binh-nguyen-a77046190_the-regulatory-transformation-of-human-drug-activity-6743051898074537984-S0Zr?utm_source=share&utm_medium=member_desktop&rcm=ACoAACzbMnsBy7xCjkg3teALCJ5qHc90nksj45g or refer to Compounding Quality Center of Excellence | FDA for latest updates.