Compounding pharmacies are licensed by the state board of pharmacy just like every other pharmacy, we are licensed by our North Carolina BOP, and our pharmacy is inspected at least once a year by a NC BOP inspector to make sure we’re following all applicable laws and regulations. Most non-compounding pharmacies are inspected or visited by an inspector every few years. We spend about a day with an inspector going over prescription records, training, documentation of inventory, the qualification/validation of our compounding labs and equipment, what medication we destroy, what states we ship to, and many other things.
As a PCAB-accredited compounding pharmacy we are inspected every 3 years by a PCAB auditor to make sure we’re following all their regulations and standards.
Compounding pharmacies (also known as 503A compounding pharmacies by the FDA) are able to compound prescriptions based on a prescription written by a prescriber (doctor, PA, NP, veterinarian, etc.) for an individual patient. We are not able to dispense large quantities of compounded medications to a doctor’s office for use “in office” or for resale to a doctor’s patient.
Compounding pharmacies follow very strict rules of what we can and cannot make. There are various lists of chemicals that are and are not allowed to be compounded with, including minimum standards of quality of chemicals. One of these lists, the 503A Bulk Drugs List, is a new list made by the FDA of what chemicals the FDA has decided are safe to be compounded with or not. There’s also a list of USP/NF monographed chemicals that are able to be compounded with, maintained by the United States Pharmacopeia.
Compounding pharmacies are able to make medications that are not commercially available, that may be allergen free, or that may be in a different form than what’s commercially available. We are not able to compound a medication because what’s commercially available is too expensive. If you can’t afford the medication prescribed you, discuss this with your prescriber.
