As determined by the Food and Drug Administration (FDA), compound pharmacies are divided into two sectors: 503A and 503B facilities. Understanding the differences between 503A and 503B pharmacies is critical when determining the best compounding pharmacy for your compound medication needs.

503A Compounding Pharmacies

503A compounding pharmacies are considered “traditional” compounding pharmacies, designated by the FDA as those that compound in accordance to patient-specific compound prescriptions and are required by the state boards of pharmacy to comply with the United States Pharmacopeia (USP) and its guidelines.  

These facilities are patient-focused and compound medications are limited to home use only as prescribed by a physician, thus 503A compounding pharmacies are prohibited from dispensing compound products for office use and may not compound in large batches.

503B Compounding Pharmacies

The FDA has designated 503B compounding pharmacies as “outsourcing facilities” that possess the ability to compound large batches to be dispensed to healthcare facilities for office use only. This type of large scale manufacturing can result in more cost effective compound solutions. 503B compounding pharmacies are not obligated to provide patient-specific compound drugs; those that do, however, are required to fully comply with additional Current Good Manufacturing Practices (CGMP).

What Are the Key Differences?

In addition to the obvious fact that 503A pharmacies dispense only patient-specific compound products, while 503B outsourcing facilities produce large batches for office use, there are a variety of supplemental key differences between the two compounding pharmacies that are important to be aware of:

  • 503B facilities must validate every process according to CGMP. This is not a requirement among 503A compound pharmacies.
  • Unlike 503A pharmacies, before a new compound product may be brought to market, 503B facilities are required to produce multiple batches and submit them for testing and stability studies. For 503B pharmacies, this can sometimes result in longer lead times in terms of getting new compound products to consumers. However, it also provides the assurance that 503B manufactured compound products meet the high standards set by CGMP and the FDA, resulting in a consistent, reliable quality product.
  • 503B testing methods, in addition to products, are required to be validated according to USP standards. 503B pharmacies also require that all suppliers of raw materials be vetted, and on-site inspections performed by a Quality Assurance team that has been set up as an independent entity are mandatory.    
  • 503A compounding pharmacies are required to perform environmental monitoring every six months, while 503B pharmacies need to at a minimum implement an environmental monitoring program that is performed per production shift in primary compound areas and weekly in secondary compounding areas.
  • Both 503A and 503B compounding pharmacies must register with each board of state pharmacy and the DEA, but 503B facilities must also register with the FDA and biannually report their product list to the FDA.
  • 503A pharmacies are permitted to assign Beyond Use Dating (BUD) when supported by internal or external scientific stability reports. 503B pharmacies, on the other hand, must implement a strong stability program that scientifically tests a medication’s response to time, temperature, and humidity to confirm the stability of the medication. 503B pharmacies are also required to label products per the Drug Quality and Security Act (DQSA).
  • Compounding pharmacists in 503A pharmacies can collaborate directly with physicians to create patient-specific compound medications, perform drug utilization reviews, and are fully responsible for each individualized compound prescription order. As 503B compounding pharmacies are able to act as outsourcing facilities and deal with large compound product batches, the role of the 503B compounding pharmacist often involves the direct supervision of compounding processes and the facility’s operational team, as well as the review of documentation from technicians and Quality Assurance personnel.

iCompound partners with an expansive network of accredited, quality 503A and 503B compounding pharmacies. Whether you are a compounding pharmacy looking to expand your reach, or a provider looking to gain access to our ever-growing network of quality compounding pharmacies and extensive compound medication list, make iCompound a part of your pharmaceutical compounding services today.