503A compounding pharmacies prepare patient-specific medications based on valid prescriptions from licensed practitioners. These pharmacies are the backbone of personalized medicine, serving providers who need customized formulations not available commercially.
Under Section 503A of the FDCA, these pharmacies may compound medications for individual patients with a valid prescription, using bulk drug substances that comply with applicable USP or NF monographs, and components that are not on the FDA's list of prohibited substances. They may not compound commercially available drugs unless there is a clinical difference for the individual patient.
503A pharmacies are regulated primarily by state boards of pharmacy. Each state sets its own licensure requirements, inspection standards, and compounding practice rules. The FDA has authority to take action for violations of federal law, including compounding drugs that are essentially copies of commercially available products or compounding without a valid prescription.
PCAB (Pharmacy Compounding Accreditation Board) accreditation is the gold standard for 503A pharmacies. PCAB-accredited pharmacies undergo rigorous inspections and must demonstrate compliance with USP <795> (non-sterile) and USP <797> (sterile) standards. Providers should prioritize PCAB-accredited pharmacies for quality assurance.
Click any pharmacy to view the full profile including formulary, accreditation, and provider onboarding information.
Houston, TX
Lakewood, CO
Nicholasville, KY
Hallandale Beach, FL
Gilbert, AZ
Orlando, FL
Ocala, FL
Baltimore, MD
Tampa, FL
Cleburne, TX
Tulsa, OK
Birmingham, AL
La Puente, CA
Atlanta, GA
Cleveland, OH
Hopkinton, MA
Anaheim, CA
Federal Way, WA
Scottsdale, AZ
Houston, TX
San Diego, CA
Swedesboro, NJ
New York, NY
Decatur, AL
Randolph, NJ
Wenatchee, WA
Nashville, TN
El Dorado Hills, CA
Woodland Hills, CA
Oklahoma City, OK
Phoenix, AZ
Boca Raton, FL
Frisco, TX
Thonotosassa, FL
Brooksville, FL
Doral, FL
Hallandale, FL
Tomball, TX
Dallas, TX
Oviedo, FL
Pflugerville, TX
Tampa, FL
Livonia, MI
Stafford, TX
Birmingham, AL
Illinois
Palm Harbor, FL
A 503A compounding pharmacy compounds medications for individual patients based on a valid prescription from a licensed practitioner. These pharmacies are regulated primarily by state boards of pharmacy and must comply with USP compounding standards.
503A pharmacies are regulated primarily by state boards of pharmacy. The FDA has limited oversight but may take action for violations of federal law, including compounding drugs that are essentially copies of commercially available products.
503A pharmacies compound for individual patients with a prescription and are state-regulated. 503B outsourcing facilities compound in larger quantities for office use without patient-specific prescriptions and are subject to FDA oversight and cGMP standards.
Yes, with limitations. 503A pharmacies may ship compounded medications to patients in other states, but must be licensed in the receiving state or comply with that state's requirements for out-of-state pharmacies. Providers should verify that their pharmacy partner is licensed in the patient's state.