Category: Uncategorized

What Is an FDA Outsourcing Facility?

In 2013, The U.S. Food and Drug Administration signed into law The Drug Quality and Security Act, which created a new section called 503B in the Federal Food, Drug and Cosmetic Act (FDCA). This act enables a compounding pharmacy to become a 503B outsourcing facility.

The legal definition of a 503B outsourcing facility is: a facility at one geographic location or address that is engaged in the compounding of sterile drugs; has elected to register as an outsourcing facility; and complies with all of the requirements of section 503B.

A compounding pharmacy must elect to register as a 503B outsourcing facility, pay an annual registration fee and meet specific conditions in order to qualify as exempt from the FDCA.

 

What Does an FDA 503B Outsourcing Facility Do?

According to the FDA, an 503B outsourcing facility is one that:

• – Compounds sterile drugs (although it may also compound non-sterile drugs as well)
• – Has chosen to register itself as an outsourcing facility
• – Has complied with all of the regulations required within section 503B
• – Must conduct all compounding by or under the direct supervision of a licensed pharmacist, although it’s not mandatory for the facility to be a licensed pharmacy
• – May or may not obtain prescriptions for identified individual patients

 

FDA 503B Outsourcing Facility Requirements

• – An outsourcing facility must comply with current good manufacturing practice (CGMP) requirements
• – All compounded drugs must be compounded under the direct supervision of a licensed pharmacist within the facility
• – All compounded drugs must be inspected by the FDA

503B outsourcing facilities must also report on information about all products compounded on location, including:

• • * A list of all products compounded in the past six months
  • * The source of the ingredients of those products
  • * Adverse events that occur

 

What Are the Benefits of a 503B Outsourcing Facility?

• – Good for Office Use: 503A compounding pharmacies are designed to dispense for home use, while 503B outsourcing facilities may manufacture for office use.
• – Frequent Monitoring: Environmental monitoring must be performed per production shift in primary compounding areas and weekly in secondary compounding areas.
• – Quality Control: 503B outsourcing facilities are required to maintain their own quality department as its own autonomous entity to conduct investigations.

 

How Can I Find Public Info About 503B Outsourcing Facilities?

For additional information about outsourcing facilities that’s been reported to the FDA over the past two years, visit the Outsourcing Facility Product Report searchable database.

 

Key Takeaways

• FDA Outsourcing Definition: An FDA 503B outsourcing facility is a facility at one geographic location or address that is engaged in the compounding of sterile drugs; has elected to register as an outsourcing facility; and complies with all of the requirements of section 503B.
• FDA Requirements for 503B Outsourcing Facilities: An outsourcing facility must compound drugs under the direct supervision of a licensed pharmacist within the facility, have their compounded drugs inspected by the FDA and comply with (CGMP) requirements.
  
• Benefits of a 503B Outsourcing Facility: they are good for office use, and require frequent monitoring and quality control.

 

Are you a provider looking to learn more about how our facility can help grow your practice? Contact us today to get started.

Contact Us

 

Understanding 503B Pharmacies

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.
• – 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.

What Is a 503B Pharmacy?

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.

A 503B 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

For TriMix injections, see why it’s important to obtain your medication from an FDA-registered 503B compounding pharmacy like Olympia.

What Are the Benefits of a Compounding Pharmacy?

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 carefully 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).

How Are Compounded Medications Used?

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 medical weight loss, HRT for men and women, erectile dysfunction, female sexual health, vein care and IV nutrition.

At Olympia Pharmacy, we understand that health and wellness needs can vary from person to person. Because no two bodies are exactly alike, we offer medication solutions designed to meet a wide range of patient requirements. Our approach is grounded in delivering options that align with your individual body chemistry and goals.

What Are Olympia’s Quality Assurance Procedures?

As an outsourcing facility, Olympia adheres to detailed requirements before compounding even begins, making us an industry leader in 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.

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.

Key Takeaways

• – 503B pharmacies were created as a result of the Compounding Quality Act with the main purpose of offering high-quality compounded medications that would otherwise be commercially unavailable.
• – A 503B pharmacy is a designation created by the FDA that establishes a new level of patient care.
• – 503B pharmacies are the only compounding pharmacies that are able to provide office-use (or “office-administered”) medications.
• – 503B pharmacies must comply with strict CGMP (current good manufacturing practices) guidelines, the same standards pharmaceutical manufacturers are held to.
• – 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.

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.

Open a Provider Account