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Tuesday 18 December 2018
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Understanding the Regulation of Compounding of Pharmaceuticals

Understanding the Regulation of Compounding of Pharmaceuticals

After the 2012 incident in which contaminated medication harmed 751 patents in addition to causing 64 deaths, the FDA assumed the role of the primary regulatory body for compounding pharmacies. One of their first major changes to the previous system was to separate pharmacies into two categories. Now all compounding pharmacies fall into either the 503A or 503B category.

503A Facilities

503A facilities are tasked with producing the medications that patients are taking in their own homes. These facilities are not allowed to produce any medications that would be sold to any medical office. In short, the 503A facilities are only permitted to make medication that are going to be used directly by the patient as a prescription to be taken at home. This also implies that only small batches of each medication are being made and that drives the cost of the production, and therefore the medication, up. In addition, the facilities are required by the state boards of pharmacy to comply with USP and guidelines.

503B Facilities

The 503B facilities are in business to produce large quantities of medications that are going to be used in medical offices or in healthcare facilities such as hospitals. These medications are not created to comply with individual prescriptions. Because these medications are being created on a large scale, the cost of production is much lower and that cost reduction is also passed along to the facility which is purchasing the medication. Because these medications are not being created to the specifications of a prescription, the facility is held to a higher standard and must comply with the current good manufacturing practice (CGMP).

Pharmacists Roles in Each Facility

In the end, pharmacists are still responsible for the accuracy and quality of the medications being produced in both facilities. In the 503B facilities pharmacists are not personally responsible for performing drug utilization reviews. Without this responsibility the pharmacists have more time to devote to supervision of the manufacturing and compounding processes. While the actual tasks might be performed by a technician and an aseptic assistant, they are completing the tasks under a much more direct supervision from the pharmacists.

The Division of Labor

The delineation of the two different medication production facilities was made in an effort to reduce the potential for errors and contaminations which can result in serious injuries or even patient deaths. By separating the prescription specific medications to a single type of manufacturing facility, the 503A, the FDA was able to create a set of standards and testing practices to ensure that personalized prescriptions were made correctly. These facilities are very familiar with the testing practices and are responsible for testing each product made as a failsafe. But this cautious manner does increase the production costs of the final medication product. Creating the 503B facility designation was to allow facilities to create very large, cost effective batches of medication to be shipped directly to medical facilities. The largest goal for the two different facilities was to provide both a high quality specific medication for prescriptions and also a method for mass production of medications at a more affordable rate.