Before the Food and Drug Administration stepped in, pharmacies were overseen by state boards of pharmacy. Due to poor oversight, deaths and serious injuries were experienced due to contaminated medications. Since then the FDA took over to regulate compounding pharmacies. In a bid to enhance safety and quality, they placed the companies in two classes.
The first, 503A, is a smaller more traditional entity that tailor-makes medications to the patient’s prescription. They only make small batches and are not subjected to as much scrutiny as the alternative. The second, 503B, is a larger entity that makes drugs with or without a prescription to follow. They sell to healthcare facilities and are held to a much higher standard. The differences between the two vary right from labeling of drugs and validation of processes to role of pharmacists and even registration.
All medication must be labeled. It ensures ease of identification and use by the consumers. 503A pharmacies have a more specialized labeling system. They include some very personal information because they have access to it. The packaging is traced with patient information, medication information, company information, and directions of use. The 503B pharmacies on the other hand follow labeling requirements as per the Drug Quality and Security Act (DQSA).
This is an essential step as it helps identify potential sources of contamination. 503A pharmacies can operate with environmental monitoring every six months. This is sufficient as production is low and contamination can easily be arrested and addressed. 503B compounding pharmacies have to have a sturdy program in place for constant and consistent environmental monitoring. It should be done after every production cycle in primary compounding areas. The secondary compounding areas a=can do with monitoring weekly.
All processes must be validated in 503B pharmacies. They must produce multiple batches of the product for testing before introduction into the market. The testing procedures themselves also have to be subjected to validation. In this instance, the suppliers of raw materials are vetted carefully.
In both types of compounding pharmacies, they ensure accuracy of the final stage. However, before then the roles differ. In 503A, a pharmacist oversees preparation. He or she can also research compounded formulas for safety and proper preparation. They can even review their own work and check it for problems then correct.
In 503B pharmacies, the pharmacist takes a direct role in supervision of the manufacturing and compounding process. They cannot review the work. An independent department has to be put in place and give full autonomy of investigation and quality assurance.
This is an important aspect as it lets the consumer and prescribing physician know how long the product should last before it is rendered toxic. 503A pharmacies use Beyond Use Dating. This is a date derived from an analysis of the scientific narrative on stability at and past a certain time.
503B pharmacies have to develop a very stringent and strict program for dating. This program is subject to degradation variables like time and humidity. This date is usually more general rather than specified down to the day.
Both kinds of pharmacies adhere to the United State Pharmacopeia pharmaceutical compounding guidelines. 503A compounding pharmacies have more leeway than the counterpart does. They are only required to register with the state boards of pharmacy and Drug Enforcement Administration.
503B compounding pharmacies are required to register with the state boards of pharmacy, DEA, and FDA. They are also required to report product lists twice every year to the FDA. This pharmacy also follows the directions given by the Current Good Manufacturing Practice.
More Attune to Safety
The tragedy of 2012 that saw the deaths of over 60 people at the New England Compounding Center should serve as motivation to maintain good quality and precise practices. These guidelines by the FDA and CGMP are in place to ensure there is never a repeat. Understanding the difference between the two works to ensure you know which kind of entity to engage for your needs.
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