Should You Use a 503A or 503B Compounding Pharmacy?

Compounding pharmacies specialize in creating custom-made medications for patients. These pharmacies are regulated by the FDA and must follow specific guidelines in order to ensure the safety and quality of their products. When choosing a compounding pharmacy what are the differences of 503B vs 503A?

Types of Compounding Pharmacies: 503A vs 503B

There are two types of compounding pharmacies: 503A and 503B. 503B is a category of pharmacy which was created as a part of the Drug Quality and Security Act, passed in 2013. Pharmacies which do not apply for 503B status are designated as 503A.

503A compounding pharmacies prepare medications on an individual basis, using only FDA-approved ingredients. These pharmacies generally do not ship their products interstate, and they are not allowed to advertise to the general public.

503B compounding pharmacies, also known as 503B outsourcing facilities, are similar to 503A compounding pharmacies, but they are allowed to ship their products interstate and advertise to the general public. In addition, 503B compounding pharmacies are allowed to mass produce some compounds for in-office use. Pharmacies with this designation must follow additional FDA guidelines, such as registering their products with the FDA and following Good Manufacturing Practices.

Both types of compounding pharmacies play an important role in providing patients with custom-made medications, but 503B Pharmacies have many advantages such as the ability to compound IM and IV nutrient therapy products for in-office use, without the need for an individual prescription. For physicians who are more thoughtful about where their products are coming from, a pharmacy with the 503B designation can provide some additional peace of mind.

What can 503B compounding pharmacies make?

503B Compounding pharmacies are limited in what they are allowed to produce for in-office use. According to the law, pharmacies with a 503B designation can only make products if:

• the FDA has determined there is clinical need to compound with the substance and places it on a list of such drugs (the 503B bulks list),
Or
• the drug compounded from the bulk drug substance appears on the FDA’s drug shortage list

The FDA solicited nominations for bulk drug substances for inclusion on the 503B bulks list and is evaluating them. Until January of this year, the bulks list had nothing on it. However, FDA has said items which have been nominated, but not yet evaluated, can be compounded until there is an evaluation.

While the FDA prepares the final 503B bulks list, all potential ingredients used by compounding pharmacies have been separated into 4 categories:

1. Bulk Drug Substances Included on the 503B Bulks List (definitely can be compounded – currently only 4 items)

2. Bulk Drug Substances Not Included on the 503B Bulks List (definitely cannot be compounded)

3. Bulk Drug Substance nominated for inclusion on the 503B Bulks List (can be compounded until FDA makes a ruling)

4. Bulk Drug Substance nominated for inclusion on the 503B Bulks List WITHOUT adequate support (cannot be compounded until FDA makes a ruling)

In January the FDA added 4 items to the bulks list (category 1), and removed several items from the nominated list (category 3) – including Folic Acid and L-Carnitine.

Folic Acid was added to the do not compound list for 503Bs (category 2). L-Carnitine was moved to (category 4). Category 4 ingredients currently cannot be compounded under 503B but could be evaluated again in the future.

While these ingredients cannot be made for in-office use under 503B regulations, some are still available on a per-patient basis under 503A.

FAQ :

Q: What is a 503B?

A: A 503B compounding pharmacy can prepare medications for individual patient prescriptions and manufacture large quantities, including IV supplements or medications used in IV therapy supplies, for healthcare facilities. These pharmacies meet higher manufacturing standards and must follow Current Good Manufacturing Practices (CGMP), similar to those used by major pharmaceutical companies.

Q: What is a 503A Pharmacy?

A: A 503A pharmacy creates medications tailored to specific patient prescriptions and follows USP 797 guidelines set by state pharmacy boards. These pharmacies cannot produce large batches, nor can they supply IV injection medications or products for office use. Their compounded medications often have shorter beyond-use dates compared to those made by 503B facilities.

Q: What is the difference between 503A and 503B?

A: The key difference is that 503B facilities must validate every process, including testing each batch, equipment, and compounding rooms, to meet FDA and CGMP standards. Unlike 503A pharmacies, 503B facilities can produce bulk quantities, such as IV starter kits, for healthcare providers.