Compounding Pharmacies and Compounded Medications:

Compounding Pharmacies:

A compounding pharmacy is a specific type of pharmacy that can make customized medications that are not commercially available. They are regulated by certain federal laws which dictate what type of compounded medications they can offer and there are also state regulations and licensing requirements for compounding pharmacies compared to community or hospital pharmacies.

Compounded Medication:

Why would a patient need componded medication? Compounded medications may be needed to improve taste of medication, remove inactive ingredients from a medication for patient who is allergic, provide a unavalible dose or forms (liquid instead of pill)of a medication, or formulate a medication that is unavailable or on backorder due to short supply. With regard to GLP-1 agonist Semaglutide it has been placed on the FDA's Shortage list. This allows compounding pharmacies to use the active ingredient to formulate a usable form of the medication. Who ensures that the compounded medication is safe? Coumpounded medications aren't FDA-approved but the FDA allows compounded medications to be produced and provided to patients when there is a medical need. There are regulatory standards in place to make sure that the coumpounded medications are safe. Only certain professionals can make coumpounded medications. The United States Pharmacopeial(USP) convention created standards to ensure compounded medications are of high quality. They set the standards for ingredients, how the compounds are made, tested and verified. Most states require compounding pharmacies to fully comply with these standards. Componding pharmacies are also regulated by the state board of pharmacy and are subject to inspections and corrective action if not meeting stancdards. Also compounding pharmacies that make sterile medications, like injectable Semaglutide, are required to register with the FDA and are inspected and have to follow current good manufacturing practices.

Why is GLP-1 agonist Semaglutide compounded?

The name brand FDA approved medications made from Semaglutide are Wegovy and Ozempic and they are in short supply and are in high demand. There are no FDA approved generic versions of these medications yet. Due to this shortage and the high demand for Ozempic and Wegovy the FDA has placed Semaglutide on the FDA's Shortage list. Being in this data base allows licensed compounding pharmacies to produce a compounded version of Semaglutide using the active ingredient Semaglutide that is slightly different then the base Semaglutide used by Novo Nordisk the manufacture of Wegovy and Ozempic.

Why use compounded Semaglutide?

High demand and costs for brand-name Semaglutide products may lead people to use compounded Semaglutide. Insurance coverage of GLP-1 agonist for weight loss is very limited and the name brand medications can cost over $1,700 a month and even the co-pays may be out of the reach of many patients. These medications have been in short supply, so the FDA is allowing access using compounding pharmacies. For those with no, or inadequate, insurance coverage for the brand name medication Wegovy or the brand name medication Ozempic the compounded Semaglutide can be an affordable option as the compounded version often cost $200 a month or less.