Today, the U.S. Food and Drug Administration approved Wegovy (semaglutide) for chronic weight management in adults with obesity, or overweight with at least one weight-related condition (such as high blood pressure, type 2 diabetes, or high cholesterol), for use in addition to a reduced calorie diet and increased physical activity. This under-the-skin injection is the first approved drug for chronic weight management in adults with general obesity or overweight since 2014. The drug is indicated for chronic weight management in patients with a body mass index (BMI) of 27 kg/m2 or greater who have at least one weight-related ailment or in patients with a BMI of 30 kg/m2 or greater. June 4, 2021
National Shortage of Ozempic and Wegovey
The FDA has listed semaglutide medications as "currently in shortage" which is one of the allowable reasons for compound pharmacies to duplicate a commercially sold drug.
Compounding Pharmacy Safety and Quality Standards for Semaglutide
The compounding pharmacy that provides our semaglutide is considered an “outsourcing facility,” as defined in The Drug Quality and Security Act, of 2013. 503A is the law that regulates patient specific medications and 503B, in the Federal Food, Drug, and Cosmetic Act, includes medications prepared for stocking the shelves with a supply that is not specifically ordered, but is safe to store for office use. Outsourcing facilities are overseen and inspected by the FDA, along with state regulators.
503B facilities must produce multiple batches and submit them for testing and stability before a new product can be brought to market. This can often lead to longer relative lead times. 503B products and testing methods must be validated according to the United States Pharmacopeia. Similarly, all suppliers and vendors providing raw materials must be vetted. On-site inspections must be performed by quality personnel.
In summary, you can be assured the compounded semaglutide you receive through this clinic is very safe and of the same quality as leading pharmaceutical manufacturers' facility. Compound medications are prepared by a 503A pharmacy only after they are ordered, therefore, the medications are never available for immediate dispensing.
Difference Between 503A and 503B Compounding Pharmacies