What is a 503B?

Key Takeaways – A 503B pharmacy is a designation created by the FDA that establishes a new level of patient care and safety. – 503B pharmacies are the only compounding pharmacies that are able to provide office-use (or “office-administered”) medications.

What is a 503B FDA?

Section 503B(d) defines an outsourcing facility, in part, as “a facility at one geographic location or address.” FDA interprets “facility,” as used in this section, to mean a business or other entity under one management, direct or indirect, engaged in the compounding of human drug products.

What is the difference between 503A and 503B?

503A drug products are designated for home use only. 503B Outsourcing Facilities are held to high standards of Current Good Manufacturing Practices that ensure quality and safety of drug products on a large scale.

What is a 503B provider?

A 503B produces ready-to-use medications needed in healthcare facilities. 503Bs fulfill a market need because they have the safety and reliability of a drug manufacturer but a much nimbler approach to creating customized options for their customers.”

What is 503B manufacturing?

The FDA has designated 503B compounding pharmacies as those with outsourcing facilities that may manufacture large batches with or without prescriptions to be sold to healthcare facilities for office use only.

Is Empower pharmacy a 503B?

Yes, Empower Pharmacy is an FDA registered 503B outsourcing facility that is licensed to manufacture custom pharmaceutical products in large quantities for bulk shipment nationwide.

Are 503B products FDA approved?

Drug products compounded by outsourcing facilities in accordance with the conditions of section 503B are exempt from FDA drug approval requirements and the requirement to be labeled with adequate directions for use.

What are CGMP requirements?

The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.

Who can 503B sell to?

503B pharmacies are large-scale FDA-regulated facilities that manufacture in bulk. They compound drugs, but not for you individually. They manufacture large batches of medications to be sold to doctors’ offices, clinics, hospitals, and other health facilities for use on-site only.

Is HCG a biologic?

The FDA has provided a preliminary list of products that were originally approved as drug products, but that will be considered biologic products as of March 23, 2020. Human chorionic gonadotropin, or HCG, is one of these drugs that will now be deemed a biologic product.

Is Empower pharmacy FDA approved?

Is Empower Pharmacy Registered with the FDA? Yes, Empower Pharmacy is an FDA registered 503B outsourcing facility that is licensed to manufacture custom pharmaceutical products in large quantities for bulk shipment nationwide.

What type of drugs Cannot be compounded by a 503B facility?

Under section 503B(d)(2)(B), a compounded drug product is essentially a copy and cannot be compounded under section 503B if a component of the compounded drug product is a bulk drug substance25 that is also a component of a covered OTC drug, unless there is a change that produces for an individual patient a clinical …