Understanding Compound Pharmacies

by Robert Duhaney, MD

Compounding pharmacies play a vital role in personalized medicine by creating customized medications tailored to individual patient needs. In this new era of GLP1 medications, getting access to the brand name medicine has proven difficult due to shifting health insurance coverage and the high cost of buying the medicine out of pocket at a retail pharmacy like CVS or Walgreens. Unlike these standard pharmacies that dispense mass-produced drugs, compounding pharmacies prepare medications by mixing or altering ingredients to suit specific medical requirements, such as adjusting dosages, eliminating allergens, or changing the form of the medication for easier consumption.

Understanding 503A and 503B Compounding Pharmacies

The U.S. Food and Drug Administration (FDA) classifies compounding pharmacies into two main categories under the Federal Food, Drug, and Cosmetic Act (FDCA): 503A and 503B. Understanding these designations is important for healthcare providers and patients alike.

503A Compounding Pharmacies

503A pharmacies are often referred to as "traditional" compounding pharmacies. Key characteristics include:

• Patient-Specific Prescriptions: They compound medications based on individual prescriptions, ensuring that each preparation is tailored to a specific patient's needs.

• Licensed Pharmacists: Compounding activities are performed or supervised by licensed pharmacists within state-licensed facilities.

• Regulatory Compliance: These pharmacies must adhere to standards set by state pharmacy boards and comply with United States Pharmacopeia (USP) guidelines, such as USP 795 for non-sterile preparations and USP 797 for sterile preparations.

  
  

An example of a 503A compounding pharmacy I use is Victory Medical Pharmacy (VMP) in South Austin, Texas. They make their GLP1s on site in per dosed syringes from certified ingredients.

503B Outsourcing Facilities

Established under the Drug Quality and Security Act of 2013, 503B facilities, known as "outsourcing facilities," have distinct features:

• Bulk Production: They are permitted to manufacture large batches of compounded medications, which can be distributed to healthcare facilities without patient-specific prescriptions.

• FDA Registration and Oversight: 503B facilities must register with the FDA and comply with current Good Manufacturing Practices (cGMP), which are stringent standards ensuring product quality and safety.

• Regular Inspections: These facilities are subject to routine FDA inspections to maintain compliance and ensure high-quality production standards.

  
  

East Austin Medicine Shop (EAMS) in Austin, Texas, is also a 503A compounding pharmacy, but for GLP1s they current rely on a 503B compounding pharmacy supplier that provides vials of GLP1 medication for some of our patients.

Why Understanding the Difference Matters

Compounded products are not the exact branded versions approved by the FDA and manufactured by the large pharmaceutical companies, rather they comprise the same active ingredients that can be prepared on a smaller scale. For healthcare providers and patients, recognizing the distinctions between 503A and 503B pharmacies can be helpful.

• Patient Safety and Customization: 503A pharmacies excel in creating highly individualized medications, making them ideal for patients with unique therapeutic needs that commercially available drugs cannot meet while maintaining potency of the product. Whereas a 503B facility adheres to cGMP standards, to ensure its quality and purity across a larger quantity of product.

• Access and Availability: 503B pharmacies can supply medications in bulk, ensuring that healthcare facilities have consistent access to necessary compounds without the need for individual prescriptions, while 503A pharmacies can give access to patients for medications and formulations either not on the market in those medicine combinations/doses or they are allowed to be compounded if the branded version is in short supply (this was the case with Zepbound and Wegovy last year).

  
  

Warning: Avoid Purchasing GLP-1 Medications from Unverified Online Sources

With the growing popularity of GLP-1 receptor agonists like semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound) for weight loss and diabetes management, many online retailers claim to sell these medications at discounted prices. While more reputable programs like Ro and Hims likely have verified suppliers such as 503B compounding facilities, purchasing GLP-1s from unregulated online sources can pose significant risks.

• Unknown Ingredients & Contamination: Without state pharmacy board or FDA oversight, there is no guarantee of quality, potency, or purity. Some online sources may sell counterfeit or diluted versions that could be ineffective or harmful.

• Lack of Proper Storage & Handling: GLP-1 medications require precise storage conditions to maintain stability. Medications purchased from unofficial sellers may not have been stored correctly, potentially compromising their safety and effectiveness.

• Risk of Adverse Reactions: If a medication is impure or contains undisclosed additives, patients may experience unexpected side effects or severe health complications.

• Legal & Ethical Concerns: Many unauthorized online pharmacies operate illegally, and purchasing from them could mean supporting fraudulent businesses that do not prioritize patient health.

  
  

To ensure safety, always obtain GLP-1 medications from licensed and accredited pharmacies, whether through traditional retail locations, manufacturer programs like the LillyDirect Pharmacy by Eli Lilly, or reputable compounding pharmacies that comply with FDA and USP regulations like VMP and EAMS.

Final Thoughts

Both 503A and 503B compounding pharmacies play integral roles in the healthcare system. By understanding their differences, healthcare providers and patients can make informed decisions, ensuring that medications are safe, effective, and tailored to specific medical circumstances. Additionally, staying vigilant about where medications are sourced—especially high-demand drugs like GLP-1s—can prevent exposure to counterfeit or unsafe products. Always consult a healthcare professional before purchasing compounded or specialty medications. Hopefully, as more GLP-1 medications become available and their benefits continue to be recognized, prices will decrease, leading to greater insurance coverage for branded versions. This would reduce the need for compounded alternatives.

**I have no personal financial ties to the compound pharmacies mentioned nor does Amazon One Medical. I just appreciate they are able to provide us with therapeutic options for patients!