What does a 503B outsourcing facility mean for you?

Olympia Pharmaceuticals is an FDA Outsourcing Facility. Outsourcing facilities are sometimes referred to as 503B outsourcing facilities because 503B refers to the filling of “office use” or “office administered” medications. The FDA created this new designation of compounding pharmacy to establish a new level of patient care and safety. Outsourcing facilities must comply with strict cGMP (current good manufacturing practices) guidelines, which is the same standards that pharmaceutical manufacturers follow. The outsourcing facilities are now the ONLY pharmacies permitted, under the new law, to provide compounded medications for use in physicians’ offices, clinics and hospitals.

Because the new 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 is the ONLY outsourcing facility in Central Florida. In fact, Olympia’s current facility, which launched in June of 2014, was built from the ground up as an FDA outsourcing facility. As an outsourcing facility, we begin each day by collecting air and surface samples in each clean room. Each technician is fully gowned and undergoes fingertip testing prior to entering the compounding environment.

When a batch of medication is completed, it is 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. For more information, visit the Q&A page for Outsourcing Facility Registration on the FDA website.

Additionally, 503B pharmacies like Olympia are indispensable during drug shortages—learn more about how Olympia Pharmaceuticals bridges the gap.

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Careful Handling of Hazardous Drugs

The U.S. Pharmacopeial Convention (USP) issued its Chapter 800 guidelines on hazardous drug handling in healthcare settings in February 2016, and its Compounding Expert Committee has set an implementation deadline of July 1, 2018. USP 800 involves those hazardous drugs as defined by NIOSH, the National Institute for Occupational Safety and Health. NIOSH defines a hazardous drug as a medication that has one of these six characteristics:

  1. Carcinogenicity
  2. Teratogenicity of developmental toxicity
  3. Reproductive toxicity in humans
  4. Organ toxicity in low levels in human or animals
  5. Genotoxicity
  6. New drugs that mimic hazardous drugs in structure or toxicity

The FDA has recently classified several commonly compounded drugs as “hazardous”. Drugs such as (but not limited too), estrogen, testosterone, HCG, progesterone and other hormone type drugs now fall into the new, hazardous classification. Any drugs in the hazardous classification must now be compounded in a “negative pressure” cleanroom. This means that during the compounding process, air must be displaced out of the room, creating a negative pressure environment. This is to protect the personnel compounding the drugs. Previously, all sterile clean rooms were positive pressure, meaning air is forced into the rooms. The air being forced into the rooms is done with a velocity to facilitate 240–480 air changes per hour to ensure the proper particle count for the corresponding ISO classification of the room. With the new hazardous classification and negative pressure requirement, compounding pharmacies are having to redesign their facilities to include negative pressure clean rooms to accommodate the new regulations. Compounders who do NOT make the required changes will not be able to compound items on the hazardous drug list, including HCG, progesterone, estrogen and testosterone. When choosing a compounding pharmacy to partner with, it is important that the pharmacy is compliant with all new rules and regulation to ensure the medications you build your practice around will be available long-term, without interruption. Olympia, as always, is the front-runner in compounding, already meeting USP 800 regulations for sterile, non-sterile, hazardous and lyophilized drugs.

Pharmaceutical quality affects every American. FDA regulates the quality of pharmaceuticals very carefully. The main regulatory standard for ensuring pharmaceutical quality is the Current Good Manufacturing Practice (CGMPs) regulation for human pharmaceuticals. Consumers expect that each batch of medicines they take will meet quality standards. Most people, however, are not aware of CGMPs, or how FDA assures that drug manufacturing processes meet these basic objectives.

CGMP refers to the Current Good Manufacturing Practice regulations enforced by the U.S. Food and Drug Administration (FDA). CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards. Accordingly, the “C” in CGMP stands for “current,” requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations. Systems and equipment that may have been “top-of-the-line” to prevent contamination, mix-ups, and errors 10 or 20 years ago may be less than adequate by today’s standards.