503A pharmacy compounding

When a drug is in shortage, compounders can prepare a compounded version of that drug if they meet certain requirements in the Federal Food, Drug, and Cosmetic (FD&C) Act. 

You can check for drug shortages on the FDA website.

Patient experienceCompounded
Regular consultations with a licensed medical provider
Anytime messaging to ask questions or report side effects
Educational resources☑️
Cash pay option
Medication delivered directly to patient's home
Picked up at preferred pharmacy
Insurance coverage optionDependent on plan inclusion and prior authorization
Doses taken via prefilled injection pens 
Doses taken via multi-dose vial and sterile syringes ☑️

Pharmacies in the CareGLP network comply strictly with all the regulatory standards established by:

  • State boards of pharmacy, which regulate all 503A pharmacies

  • FDA, which has oversight for the safety of all active pharmaceutical ingredients

  • DEA, that oversees the controlled substances sometimes used in compounded preparations

  • USP Convention, that issues practice standards ensuring quality and safety of medications and food

  • USP General Chapter <795> provides guidelines for the prevention of contamination and potency variance, preparation process, beyond-use dates, and stability for non-sterile compounding

Pharmacies in the CareGLP network run quality assurance and quality control checks for every batch of compounded semaglutide prescribed to patients.

Some of these steps include but are not limited to:

  • Reviewing and confirming the Active Pharmaceutical Ingredient (API) Certificate of Analysis for all semaglutide base lots, which are received from FDA-registered manufacturers;

  • Storing the verified API frozen and sealed until use;

  • Compounding with the API under aseptic processes to produce specific lots (vials);

  • Holding the vials of compounded semaglutide in quarantine (representative samples are taken for testing);

  • Using independent third-party laboratories to test the potency, sterility and endotoxicity of each lot of compounded semaglutide (among other criteria);

  • Reviewing the results of these tests and, if satisfactory, releasing the validated vials from quarantine for dispensing; 

  • Assigning each compounded lot a unique lot number and BUD (Beyond Use Date), which is added to the container and is tracked electronically;

  • Scanning the lot information on the product at the time of dispensing, which ties a particular lot number to the patient’s file.

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