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Understanding 503B Pharmacies

Close-up of lab worker writing down medication information

Olympia Compounding Pharmacy understands the importance of providing both patient-specific and office-use needs across the country. That’s why we’re equipped with two separate, state-of-the-art facilities — one to fulfill 503A compounding pharmacy needs and the other for 503B.

But let’s explore more of what a 503B FDA outsourcing facility actually is. Here are the main distinctions:

  • 503B pharmacies are the only compounding pharmacies that are able to provide office-use (or “office-administered”) medications. Outsourcing facilities are sometimes referred to as 503B facilities.
  • A 503B pharmacy is a designation created by the FDA that establishes a new level of patient care and safety.
  • 503B pharmacies must comply with strict CGMP (current good manufacturing practices) guidelines, the same standards pharmaceutical manufacturers are held to.

These 503B outsourcing facilities are the only pharmacies permitted to provide compounded medications for use in physicians’ offices, clinics and hospitals.

 

503B Pharmacy Designation

The FDA carefully regulates the quality of compounded pharmaceuticals. The Compounding Quality Act, passed in 2013, defined a new designation of compounding pharmacy, called a 503B Pharmacy. This type of pharmacy is directly regulated by the FDA using CGMP regulations. CGMP regulations are the same ones followed by pharmaceutical manufacturers. Therefore, a 503B pharmacy is a compounding pharmacy that operates under cGMP guidelines, which are very stringent.

Additional benefits of 503B  pharmacies include:

  • – 503Bs test every batch of medication for endotoxin, sterility and potency
  • – 503Bs can offer extended beyond-use dates because of the rigorous testing performed under CGMP

Benefits of a Compounding Pharmacy

Pharmacist customizing medication

Of the approximate 56,000 community-based pharmacies in the U.S., about 7,500 pharmacies specialize in compounding services, and of those, less than 80 are FDA-approved. This means the pharmacists in 503B compounding facilities are fully dedicated to compounding special preparations for patients and have made the investment in equipment and training to do so safely and efficiently. The preparations offered by compounding pharmacies can be non-sterile (ointments, creams, liquids or capsules that are used in areas of the body where absolute sterility is not necessary) or sterile (intramuscular injection, intravenous and eye drops).

 

Compounded Medication Uses

Your healthcare provider will prescribe a compounded drug only when commercially available drug products do not meet your needs. Many specialties utilize compounding for more individualized patient care. Some of the specialties Olympia compounds medication for include HCG/medical weight loss, HRT for men and womenerectile dysfunction, female sexual health, vein care and IV nutrition.

At Olympia Pharmacy, we know that every patient has unique health and wellness needs. All bodies are different and when it comes to your medications, we have customized solutions to suit all types of patients. Our foundation is built on providing the right solutions for your unique body chemistry.

 

Olympia’s Quality Assurance Procedures

As an outsourcing facility, Olympia adheres to detailed safety requirements before compounding even begins, making us an industry leader in safety, compliance, quality and customer satisfaction. Each day, air and surface samples are taken in each clean room. Each technician is fully gowned and participates in fingertip testing before entering the compounding environment. When a batch of medication is completed, it’s placed in a special quarantine area while samples from the batch are sent off for independent, third-party laboratory testing. Independent lab tests are performed for sterility, endotoxins and potency. This testing normally takes 14 days to complete. When the tests come back satisfactory, the medications are then released from quarantine and are available to be dispensed to patients or physician/clinic offices.

The procedures and guidelines we follow make an outsourcing facility, by far, the safest place to obtain medications from. Because these rules are so stringent, only a handful of compounders in the United States have elevated their pharmacies’ to the new FDA outsourcing facility designation. Olympia Compounding Pharmacy is currently the only outsourcing facility in Central Florida.

Now that you know more about 503B pharmacies, learn more about the other half of our business: our 503A pharmacy and how Olympia uses both designations to help our customers comply with all national and state regulatory requirements while using a single-source pharmacy partner.

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