What is a FDA 503B?
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 an outsourcing pharmacy?
Outsourcing is a formal arrangement by which a health care organization contracts with an outside company to obtain selected pharmaceutical services or comprehensive management of the organization’s pharmacy.
Does the FDA outsource?
FDA inspects outsourcing facilities for compliance with CGMP requirements and the conditions of section 503B, in addition to other requirements of the FD&C Act. FDA does not generally request that an outsourcing facility wait for an FDA inspection before initiating drug production.
What is Section 503A?
Section 503A of the FD&C Act applies to human drug compounding by a licensed pharmacist within a state-licensed pharmacy or federal facility, or by a licensed physician, that is not registered with FDA as an outsourcing facility. Section 503B applies to human drug compounding within an outsourcing facility.
What is 503503b outsourcing and how can it help hospital pharmacy?
503B outsourcing can assist hospital pharmacy by freeing up time and capital that may otherwise be spent compounding products in the hospital pharmacy. It can also reduce the regulatory and compliance risk associated with increasing requirements for hospitals doing their own sterile product compounding.
What is the 503B(b) Act?
Under section 503B (b) of the FD&C Act, after the initial registration, a facility that elects to continue to be registered with FDA as an outsourcing facility must re-register annually.
When will my outsourcing facility be removed from the list?
Unless a previously registered outsourcing facility re-registers and pays the annual establishment fee in full during the registration period (between October 1 and December 31 of each calendar year), the facility will be removed from the list of registered outsourcing facilities on January 1 of the next calendar year. 2.
How do I determine whether a Registered outsourcing facility is regulated?
To determine whether a registered outsourcing facility has been the subject of a state enforcement action, check with the State Board of Pharmacy for the state in which the facility is located. Some states post disciplinary or other actions on their web sites. 5.