What is a 503A Compounding Pharmacy?

Expanding Patient Access With a 503A Compounding Pharmacy

503A pharmacies compound medications for specific patients whose prescriptions are sent in by their healthcare provider. 503A refers to a section of the Federal Food, Drug, and Cosmetic Act that applies to the compounding of medication by a licensed pharmacist in a state-licensed facility, or by a licensed physician, that is not registered as an FDA outsourcing facility. 

Tailored for Patients’ Convenience

Patient preference is key with 503A compounding pharmacies. These types of pharmacies create customized medications to suit patients' individual needs. Commercial medications don’t always meet patients’ needs, so a 503A compounding pharmacy creates individualized products to meet them. For example, if a patient is allergic to a dye or ingredient in a commercial drug, a compounding pharmacy can create the drug without that allergen so the patient can take the medication.

When utilizing a 503A compounding pharmacy, patients can trust that their prescriptions are tailored to their individual clinical needs, health journeys and lifestyles. 

Regulating 503A Compounding Pharmacies

Unlike a 503B outsourcing facility that produces large-scale batches of medications for use in medical offices, a 503A facility produces patient-specific medications pursuant to a prescription.

It is required by state boards of pharmacy to adhere to the United States Pharmacopeia (USP) chapter <797>, <795>, <800> and other guidelines. USP develops standards around product integrity, safety and purity in compounding. 

USP General Chapter <797>: This is a set of guidelines for sterile compounded preparations. This type of compounding utilizes aseptic technique, which happens in an environment free of bacteria, viruses or other foreign microorganisms. The professionals who compound this way must wear sterile gloves, gowns and masks, use sterile equipment and must minimize the number of people in the environment. Products that are administered intravenously (IV), subcutaneously (SQ), or intramuscularly (IM) are created in a sterile environment.  

USP General Chapter <795>: This is a set of guidelines specifically for nonsterile compounded preparations. The standards are still high to ensure the quality and safety of products, but they are not as rigid as those for sterile compounding. Nonsterile products are often medications in powder, tablet, cream, or capsule form, among others. Empower Pharmacy compounds both sterile and nonsterile products. 

USP <800>: This set of guidelines applies to the handling of hazardous drugs in healthcare settings. It exists to make sure hazardous drugs are handled properly to make sure there is minimal risk of exposure to compounding operators, healthcare providers and other healthcare workers. 

Oversight & Standards

State boards of pharmacy regulate 503A compounding pharmacies, but compounding pharmacies are also subject to some oversight by state and federal agencies. The DEA has primary oversight of any controlled substances (i.e., testosterone) present in compounded products. The FDA has published guidance that applies to 503A compounding pharmacies. 

Empower Pharmacy is licensed nationwide, partners with licensed providers and meets or exceeds industry standards.

About Empower Pharmacy

Empower’s vision is to expand access to quality, affordable medications. The company’s purpose is personal for CEO, Shaun Noorian. He started Empower in 2009 after being prescribed compounded medication for a hormone disorder. He soon found out that millions of others did, too. 

Today Empower Pharmacy operates state-of-the-art facilities and employs an impressive lineup of licensed pharmacists and other industry experts to create quality products for providers and patients around the country.  We are licensed nationwide and can ship prescriptions directly to patients.