In 2012, 64 deaths and 751 injured patients resulted from a contaminated medication from the New England Compounding Center. This incident was ostensibly due to insufficient oversight by the state boards of pharmacy.
503A Compounding Pharmacy
The FDA has classified 503A facilities as traditional compounding pharmacies that dispense compounds in accordance with patient-specific prescriptions that comply with United States Pharmacopeia (USP) guidelines.
503A compounding pharmacies are prohibited from dispensing for office use which limits their product line to items for in-home patient use. Moreover, the facility may not compound large batches which often increases the product cost.
These limitations have been addressed by creating exemptions for a compounding pharmacy as a 503B.
503B Compounding Pharmacy
The FDA refers to 503B facilities as outsourcing facilities that may produce large batches to be sold to healthcare facilities without prescriptions as office use only. This was done to lessen production costs associated with small, prescription-based batches thereby providing more affordable medication to healthcare facility patients.
Though not required to provide patient-specific medications, the healthcare facility pharmacies are held to a higher standard as they are classified as a manufacturer requiring full current good manufacturing practice (CGMP) compliance.
Prime Differences between 503A and 503B Compounding Pharmacies
A prime difference between a 503A and a 503B facility is that every process in a 503B facility must be validated. Also, before a new product can be put on the market multiple batches must be made and tested as well as analyzed for stability.
Prior to active testing, testing methods must first be validated to ensure accurate, precise results in accordance with USP standards. Vendors supplying critical raw material must also be vetted by on-site inspections to ensure quality assurance of all raw material going into a given compound.
The requirements governing 503B compounding pharmacies validate the quality and stability of custom product combinations. It gives the industry the ability to generate these custom product combinations in a unit dose fashion with an extended shelf life.
At Blue Thunder Technologies, we are committed to helping your facility comply with all the standards governing a 503B and 503A and to help you ensure that your 503B facility is in full compliance with current CGMP and FDA regulations.