503A or 503B—Knowing when to order from each one

Should you order from a 503A compounding pharmacy or a 503B outsourcing facility? Read on to learn the difference between them and why it matters.

Where do you get your compounded medications? Before the introduction of 503B outsourcing facilities in 2013, this was a pretty straightforward question. Now, there are more sources than ever for your veterinary patients’ compounded drugs. The increased options add complexity to both patient and bulk in-house clinic orders. But, arming yourself with knowledge about the differences between 503A compounding pharmacies and 503B outsourcing facilities, as well as the questions to consider when deciding where to order, can demystify this choice.

Understanding the specifics behind the products you receive from 503As and 503Bs will give you confidence that you’re providing your patients with the highest standard of care.

What is the difference between 503A and 503B?

503A compounding pharmacies and 503B outsourcing facilities may be the same species but they’re not the same breed. Familiarity with the differences between the two can help you make an informed decision on which type of compounder will best meet your needs and ensure your patients receive the highest-quality care. Let’s review the basics.

503A Compounding Pharmacies

503A compounders are the traditional, neighborhood compounding pharmacies that are familiar to most veterinarians. 503A compounding pharmacies:

  • Are regulated primarily by the State Board of Pharmacy (SBOP).
  • Must comply with United States Pharmacopeia (USP) standards for compounding nonsterile and sterile medications (USP 795 and USP 797) and SBOP regulations.
  • Are limited to dispensing medications for home use only when a patient-specific prescription is available; the customized formulations are produced to meet the needs of an individual patient.
503B Outsourcing Facilities

503B manufacturers and outsourcing facilities, in contrast, are newer, coming into existence in 2013 with the implementation of the Drug Quality and Security Act, which added Section 503B to the federal Food, Drug, and Cosmetic Act. 503B outsourcing facilities:

  • Are regulated by the United States Food and Drug Administration (FDA).
  • Must comply with the FDA’s current Good Manufacturing Practice (cGMP) standards (21 CFR Parts 210 and 211) in addition to USP 795, USP 797, and SBOP regulations.
  • Can dispense large quantities of traditionally compounded veterinary medications for office use with or without a prescription; the customized drug therapies produced can address both patient and practice needs.

What Is cGMP Compliance and Why Does It Matter?

While both traditional 503A compounding pharmacies and 503B outsourcing facilities have quality and safety requirements they are obligated to meet, 503B outsourcing facilities are held to more rigorous standards—the same standards as human pharmaceutical manufacturers.

Read on to learn what compliance with cGMP standards looks like for 503B outsourcing facilities. And let’s take a look at some questions and answers that will help you decide which type of supplier—503A or 503B—best meets the needs of your patients and your practice.



Subscribe to NEWStat