4 Things To Know About 503B Outsourcing Facilities


The drug manufacturing industry is comprised of at least two kinds of pharmacies—one is to create standard medication for people to buy and use at home and the other is a medication that’s formulated only for doctors to dispense at their healthcare offices.

They both play an important role in the public health system to supply the medication people and even animals need daily. Though you might be familiar with a regular pharmacy, outsourced centers are still relatively unknown by those outside of this sector.

Here are four things to know about 503B outsourcing facilities:

What Is A 503B Facility?

There are various types of pharmaceutical companies involved in the manufacturing of medication, and one of such is a pharmacy known as a 503B facility. They’re outsourced pharmacies that compound sterile medication. In order to comply with the criteria of the FDA, these facilities need to be registered in one geographical location or address. They also need to follow FDA guidelines and regulations while adhering to Current Good Manufacturing Practices (CGMP).

Furthermore, an outsource compounding center dispenses for office use medications—medicine that isn’t sold commercially and is administered by a doctor when it’s sent to their office. The work of a compounder is to mix and create customized medicine for patients with unique conditions. They can also combine ingredients for specialized medication for partnered healthcare providers.

Why Are 503B Facilities Necessary?

The Federal Food, Drug, and Cosmetic Act (FD&C) added section 503B to the Drug Quality and Security Act in 2013. This was to address growing concerns about the safety and quality of compounded drugs. As such, the benefits of passing this act have improved the quality of medicine manufacturing on a larger and more industrial scale.

In addition to this, these outsourcing facilities came about in the first place to meet the needs of human and animal patients who can’t be treated with generic medicine available on the market. Veterinarians, for instance, work with a variety of animal species with differing biology. They’ll most often require personalized medicine for pets such as cats with distinct conditions.

Human physiology can also be diverse and call for a combination of separate medical ingredients to treat an illness. Therefore, 503B centers can create personalized medicine that’s tailored to each patient’s needs.

What Are The FDA Regulatory Policies?

The FDA has a strict policy to ensure outsourced compounding facilitates adhere to CGMP and stay committed to the quality and safety of new drug creations. Some of the regulations include:

  • Testing for potency, sterility, and endotoxins of finished products
  • Compounded drugs must be inspected by the FDA
  • Drugs must be compounded under the supervision of the senior pharmacist
  • Environmental monotiling to prevent contamination
  • Validating the safety and functionality of manufacturing equipment
  • Having a detailed and documented list of ingredients and their raw materials
  • Training staff and facility personnel on best practices and up-to-date standards
  • The facility must meet the design standards set and approved by the FDA

These are just a few of the general key details of the FDA regulations has set out for outsourced pharmaceutical manufacturing. There are many more guidelines and information acts in place for specific cases. These can be faculties involved with medical devices, injectors, containers, and innovative combination products.

What Is The Difference Between 503A And 503B Facilities?

503A is the code used for traditional or regular pharmacies. These are the well-known and widely used facilities where a compounder or pharmacist can only dispense prescription-specific medication. They’re in many ways the opposite of how a 503B facility can operate.

The major differences to be aware of are in terms of regulations, prescription, and production. For instance, traditional pharmacies or 503A aren’t licensed by the FDA and don’t have to follow CGMP protocol. They’re mostly regulated by a pharmacy board of each state. These pharmacies are also limited in the production volume of drugs they can manufacture and distribute.

On the other hand, 503B facilities are strictly regulated by the FDA and have a higher production volume by creating medicine using bulk ingredients. Patients can’t take this medicine home as it’s only allowed to be used for office by doctors in hospitals, clinics, and other healthcare centers. Many pharmaceutical companies and healthcare providers usually have both types of manufacturers within their supply chain to fulfill the demand for each medicinal usage.


A 503B outsourcing facility is a non-traditional pharmacy that compounds personalized medication for use in a doctor’s office only. They’re only able to operate once they’re given the go-ahead by FDA policy and meet the requirements. These facilities are strictly regulated to ensure the drugs being made are safe for human and animal consumption. All of this is necessary to create uniquely tailored medication in a sterile environment and improve the quality and efficacy, as well as minimize potential harm.

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