Understanding the Differences Between 503A and 503B Compounding Pharmacies

Haleigh Wilkes, PharmD, of Eagle Pharma Outsourcing has special insight on what it is like to run a 503B compounding pharmacy: "FDA’s purpose for 503B outsourcing facilities is to help fill the gap between the abilities of large-scale manufacturers and the growing demands for medications essential to the health and well-being of patients in this country. Primarily the medications produced by outsourcing facilities are shipped directly to medical practitioners and healthcare facilities. More recently, however, the FDA has expanded the role of 503B outsourcing facilities allowing them to supply their high-quality compounded medications directly to 503As in efforts to supplement their ability to meet the increased demand for patient-specific compounded medications. 

Because outsourcing facilities must adhere to the standards of Good Manufacturing Practices, all medications produced by a 503B are held to the same quality standards, including those dispensed directly to patients. These standards include rigorous process validation and testing prior to being released to both medical practitioners and patients. Something important to understand about outsourcing facilities is that due to the intense process validation and lengthy drug studies necessary to produce a specific compounded medication, it takes at least six months to have a product that is ready for release. Because of these highly regulated processes, it is not easy to make changes to a compounded formulation and it is very costly to bring additional medications onto a 503B formulary. Therefore, while a 503B may not be able to respond quickly to all of the rising medication demands, you can trust that compound we produce has undergone thorough validation."

Joseph Drummond, PharmD, of Austin Compounding Pharmacy has been working in 503A compounding pharmacies for over twelve years.  He is very passionate about helping his patients achieve their health goals and consults with them to ensure they have all of the support they need to meet their objectives.

"The FDA’s intent for 503A is to protect patients from public health risks of providing compounded drugs to patients’ whose medical needs could be met by commercially available drug products and to protect the integrity and efficiency of the drug approval process. This is accomplished by requiring patient-specific prescriptions, pharmacist oversight on compound creation, state board of pharmacy compliance, USP/NF compliance, and ensuring bulk substance quality in order to remain in good standing with the regulators.

Pharmacists don’t just dispense medications to their patients. Oftentimes, pharmacists are the only practitioner patients speak to about their health questions besides the short time they have with their prescriber during their office visit.

On the front line talking with patients, these pharmacists help patients understand why they are taking meds, how to properly use their medication, potential side effects and even helping them identify potential drug induced nutrient depletions to avoid future issues and improve compliance with the medication. With their commitment to quality and safety, 503A pharmacists are an important mediator in the US health care system, underscoring their importance in their role as patient advocates.

Our pharmacy carries a large inventory of OTC medications and supplements to address any potential nutritional shortcomings and optimize the health of our patients in a holistic manner. Over time, 503A pharmacists get to know their patients personally and patients in turn come to trust and seek pharmacist expertise to help guide them along their healthcare journey towards greater wellbeing."