What is 503B?
If you are unfamiliar with 503B Outsourcing Facilities, they are compounding facilities that compound sterile and non-sterile medications.
An outsourcing facility is defined as “a facility at one geographic location or address that
- is engaged in the compounding of sterile drugs
- has elected to register as an outsourcing facility
- complies with all of the requirements of the section 503B”
In 2013, the Drug Quality and Security Act (DQSA) added Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C). 503B outsourcing facilities are subject to current good manufacturing practices (cGMP), because the drugs compounded by outsourcing facilities are not exempt from section 501(a)(2)(B) of the FD&C Act
Source: https://www.fda.gov/media/97359/download
503B and 503A Differences
The main differentiators between the two types of facilities are prescription requirements, safety and quality, cost savings, availability, liability, and regulatory authority.
| 503B
Outsourcing Facilities |
503A
Traditional Pharmacies |
|
Prescription Requirements |
Does not require a patient prescription / Can be used for office use | Must have a patient prescription / cannot be used for office use |
Safety and Quality |
Required by FDA to follow strict testing standards for sterility, potency, endotoxins / Products compounded in ISO clean rooms that are continuously monitored for particulate matter and environmental conditions | Not licensed by FDA, thus FDA is unaware of potential problems with drugs or compounding practices / environmental monitoring is performed every 6 months |
Cost Savings |
Savings from compounded drugs made with lower-cost bulk drug ingredients | Lower production volumes lead to higher per-unit costs |
Availability |
Ability to produce drugs in limited supply on the FDA Short List/ability to meet market demand volume without the requirement of patient prescriptions | Products not available for office use / FDA limitations on interstate distribution |
Liability |
Must comply with current good manufacturing practice (cGMP) requirements and US Pharmacopeia Guidelines (USP) | Does not comply with current good manufacturing practice (cGMP) |
Regulatory Authority |
Must follow state regulations and voluntarily register with the FDA | Regulated by State Board of Pharmacies |