The main difference between 503A and 503B pharmacies lies in their operations and regulations:

503A Pharmacies: These are traditional compounding pharmacies that create customized medications for individual patients based on specific prescriptions. They are typically state-licensed and must comply with the United States Pharmacopeia (USP) standards.

503B Pharmacies: These are known as outsourcing facilities. They produce larger batches of compounded medications intended for use in healthcare facilities, rather than for individual patients. They must comply with more stringent Current Good Manufacturing Practices (CGMP) and are regulated by the FDA.

In essence, 503A pharmacies focus on personalized patient care, while 503B pharmacies aim to provide a steady supply of compounded medications to healthcare facilities on a larger scale.

Let’s look a bit deeper into the differences between 503A vs 503B.

503A Pharmacies

Regulation: These pharmacies are regulated by state boards of pharmacy. They must comply with the United States Pharmacopeia (USP) standards, which include guidelines for compounding practices.

Scope: They primarily compound medications for individual patients based on specific prescriptions. This means each compounded medication is tailored to a single patient's needs.

Facilities: Typically, 503A pharmacies are smaller and may not have the same level of equipment and facilities as 503B pharmacies.

Examples: A doctor might prescribe a compounded cream for a patient with a specific allergy, and the 503A pharmacy would create that cream according to the prescription.

Medications from a 503A pharmacies follow the United States Pharmacopeia (USP) guidelines, which often result in shorter Beyond Use Dates (BUDs), sometimes as little as 12 hours for sterile products.

503B Pharmacies

Regulation: These pharmacies are regulated by the Food and Drug Administration (FDA) and must comply with Current Good Manufacturing Practices (CGMP).

This involves more stringent standards for cleanliness, quality control, and documentation1

Scope: They produce larger batches of compounded medications intended for use in healthcare facilities, such as hospitals and clinics.

These medications are not personalized for individual patients but are designed to meet the needs of multiple patients.

Facilities: 503B pharmacies are usually larger and have more advanced equipment and facilities to ensure the production of high-quality medications.

Examples: A hospital might need a compounded medication in bulk for multiple patients, and the 503B pharmacy would produce and supply that medication.

Medications from 503B pharmacies generally have a longer shelf life compared to those from 503A pharmacies.

This is because 503B pharmacies must comply with the FDA's Current Good Manufacturing Practices (CGMP), which include rigorous stability testing.

As a result, the expiration dates for 503B medications can range from months to years.

Key Differences

Expiration date of Medication: Medications from 503B pharmacies generally have a longer shelf life compared to those from 503A pharmacies.

Regulatory Body: 503A is state-regulated, while 503B is FDA-regulated.

Scale of Production: 503A focuses on individual prescriptions, whereas 503B produces larger batches for healthcare facilities.

Standards: 503A follows USP standards, while 503B adheres to CGMP standards.

Our policy 

We work with our patients regarding using their local pharmacy of choice. However, due to the vast difference in standards and quality between types of pharmacies we will only send prescriptions (e-prescriptions) to local commercial pharmacies such as HEB, Wal-Mart, Costco, etc. We will not send prescriptions to compound or online pharmacies.