The Beauty of a 503B

What is an FDA-Registered 503B Outsourcing Facility?

SKNV is an FDA-Registered 503B Outsourcing Facility, which means the company operates under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Section 503B applies to a category of drug compounders called outsourcing facilities.

503B Outsourcing Facilities:

must produce drugs under Current Good Manufacturing Practice (CGMP) requirements
must adhere to strict FDA regulation
must adhere to state boards of pharmacy regulations
do not require patient-specific prescriptions
can manufacture medications in large batches
can help navigate drug shortages

503B Outsourcing Facilities are not the same as 503A Compounding Pharmacies. 503A Compounding Pharmacies are not registered or regularly inspected by the FDA, cannot compound in large batches, and do not allow practices to dispense from their office.

Great to Be a 503B

Why the “B” Makes SKNV’s Big Difference

For SKNV, being a U.S. FDA-Registered 503B Outsourcing Facility gives us many advantages over traditional compounding pharmacies.

Quality-Rich Environment: We comply with strict safety and quality assurance guidelines regulated by both the FDA and the state boards of pharmacy. We follow current good manufacturing practices to ensure adequate facility design, monitoring, and control.
Bulk Production, No Prescriptions Necessary: Not only are our compounded medications high-quality, but they are also produced in large batches without requiring a patient-specific prescription.
Office Use: Practices can dispense our medications from their office.

There are no exclusive benefits of 503A Compounding Pharmacies. Being a 503B Outsourcing Facility provides a clear advantage for practices focused on patient convenience and Rx quality.

History

How 503B came to be

In 1938, Congress passed a set of laws giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics. Dubbed the Federal Food, Drug, and Cosmetic Act (FD&C Act), this gave the legal framework within which the FDA operates.

In 2013, a 503A company, New England Compounding Center, caused a tragic and deadly meningitis outbreak due to their contaminated medications. This major incident highlighted significant lapses in the quality control and safety standards of compounded drugs.

After this incident, Congress passed the Drug Quality and Security Act (DQSA), which amended the FD&C Act to grant the FDA more authority to regulate and monitor the manufacturing of compounded drugs. This legislation aimed to prevent future tragedies by ensuring higher standards of safety and quality in the compounding pharmacy industry. A new category of FDA-regulated companies was born, and this is why SKNV was founded.

DQSA ADDED SECTION 503B

A new category of compounders called outsourcing facilities was created.

The DQSA permits compounding from bulk drug substances if they have either of the following:

The commercially approved drug is on a drug shortage list.
There is a clinical need for it. The FDA creates a list based on clinical need.

In 2015, SKNV stepped into the dermatological space as an FDA-Registered 503B Outsourcing Facility. SKNV addresses the clinical need for topical medications for sensitive skin, as 70% of people report having sensitive skin.

SKNV medications, manufactured in our Florida FDA-Registered 503B Outsourcing Facility, are clinically different (as determined by a provider for each patient) than commercially available medications.

503B IS THE BETTER CHOICE

The Preferred Choice for Enhanced Drug Safety and Compliance

Practices cannot dispense from their office with a 503A, and the FDA does not regulate or measure 503A prescription drug manufacturing processes. In comparison, there are no exclusive 503A benefits.

A 503B is the clear choice and advantage for practices focused on patient convenience and Rx safety.