Today, most medications are commercially manufactured in massive factories and sent to pharmacies for pharmacists to dispense. But hundreds of years ago, pharmacists prepared most, if not all, medications in the pharmacy. This is known as compounding: “the preparation, mixing, assembling, packaging, and labeling of a drug … in accordance with a licensed practitioner’s prescription…” according to the US Pharmacopeia Convention (USP). Compounding pharmacists are trained to apply their knowledge to routinely prepare non-sterile or sterile medications.
The FDA and State Boards of Pharmacy regulate compounding pharmacies to make sure they are preparing high-quality medications thus ensuring patient safety. The FDA has divided compounding pharmacies into two categories: 503A and 503B facilities.
503A pharmacies focus on providing patient-specific compounded prescriptions. A 503A pharmacy can specialize in compounding medications for a variety of health specialties, such as dermatology, hormone therapy, urology, pediatrics, etc.
However, a 503A facility is not able to compound large batches of medications to sell to clinics or other healthcare facilities for general office use. Products from 503A pharmacies are dispensed for an individual patient.
503B pharmacies can compound large batches of medication to be dispensed to clinics, doctors’ offices and other healthcare facilities for general office use. A 503B pharmacy is not required to fill patient-specific prescriptions, but must comply with Current Good Manufacturing Practices (CGMP) and submit documentation of processes and testing results. Testing is an essential step to ensure that bulk products comply with CGMP and FDA regulations.
In some cases, 503B pharmacies compound items that require specialized equipment or are considered too complex to be made in a traditional pharmacy. For example, lyophilized powders, implantable pellets that require gamma radiation and other hard to make medications.
Pharmacists play an essential role in both 503A and 503B pharmacies. Pharmacists in 503B facilities primarily supervise the proper documentation and manufacturing of large compounded orders. 503A pharmacists may have more hands-on involvement in tailoring preparations to patient-specific needs.
Both 503A and 503B pharmacies must comply with state and federal regulations, submit to unannounced inspections and complete third-party testing for their preparations. Additionally, the facilities themselves must comply with environmental monitoring, hazardous drug handling standards and employee training.
Talk to a pharmacist at The Compounding Center to learn more about our compounding services. We are a traditional 503A compounding pharmacy and truly enjoy collaborating with prescribers to meet the needs of each individual patient.