When it comes to compounding pharmacies, all are not created equally. Here is an overview of the different designations and why that matters in the pharmaceutical industry today.

What is a 503A Compounding Pharmacy?

A 503A compounding pharmacy compounds to accommodate patient-specific prescriptions and is required by the state boards of pharmacy to comply with USP 797 Guidelines. 503A pharmacies are not permitted to distribute for office use, nor are they permitted to compound large batches of product. Medications compounded by 503A pharmacies normally have much shorter beyond use dates than those compounded at a 503B.

What is a 503B Compounding Pharmacy?

A 503B compounding pharmacy may also compound to accommodate patient-specific prescriptions, but is permitted to manufacture large batches of a product that can also be sold to healthcare facilities for office administration. 503B pharmacies are also held to higher manufacturing standards and must be fully compliant with current good manufacturing practice (CGMP) regulations, which are the same regulations followed by big pharma.

The Biggest Differences Between 503A and 503B

The biggest difference between the 503A and 503B designations is that 503B facilities are required to have every process validated, whereas 503A facilities are not.

What does that mean for 503B facilities? Every batch of medication must be submitted for testing prior to being released to market. This guarantees that all batches are consistent and meet FDA and CGMP standards. Additionally, testing methods, equipment and compounding rooms and must be validated to ensure accuracy as per CGMP guidelines.

nurse examining a bottle of blue liquid

503A vs. 503B Overview

Both 503A and 503B designations play important roles in the healthcare industry at different levels. However, only 503B pharmacies have the benefit of being able to produce on a larger scale, create medications for office use and provide extended BUDs (beyond-use dates).

doctor handing a patient medication

Major Benefits of 503B Pharmacies

Quality Assurance:

With stricter FDA regulation standards than 503A pharmacies, 503B pharmacies can guarantee they’re producing the highest-quality products.

Office Use:

503B pharmacies are the only compounding pharmacies permitted to manufacture products for office use, which includes products used in physician offices, clinics and hospitals.

Drug-Shortage Assistance:

During drug shortages, a 503B pharmacy can step in to manufacture the unavailable medications, ensuring productivity is not affected while the shortage occurs.

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