503A & 503B

What is a 503A and 503B? 

Central Drugs is your compounding pharmacy provider. We can compound your needs through our 503A pharmacies and 503B outsourcing facility. Discover the difference and how we can service your needs at each of our locations.

503A with Central Drugs Compounding Pharmacy

According to the Food and Drug Administration (FDA), section 503A of the Federal Food, Drug, and Cosmetic Act focuses on pharmacy compounding of human drugs.

At Central Drugs, we have two pharmacy locations, La Habra and Fullerton, CA. As a 503A compounding pharmacy, we:

  • Require patient specific prescriptions
  • Provide custom medication 
  • Follow up with patients 
  • Compliant with compounding standards <795>, <797>, and <800> chapters of the United States Pharmacopeia
  • Licensed in 37 states

503B with Central Drugs Outsourcing Facility

Section 503B of the Federal Food, Drug, and Cosmetic Act permits compounding of sterile drugs as an outsourcing faciity.

Open in 2017, Central Drugs Outsourcing Facility is:

  • Registered with the FDA
  • cGMP (Current Good Manufacturing Practices) compliant
  • Can compound drugs from the FDA Drug Shortage List
  • Service hospitals, offices, surgery centers, and veterinary clinics
  • No patient specific prescriptions are needed
  • Licensed in over 20 states

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