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What is a 503B outsourcing facility for compounded medications?
A 503B Outsourcing Facility is a type of compounding pharmacy authorized by section 503B the 2013 Federal Drug Quality and Safety Act (“DQSA”) that compounds medication for individual patients pursuant to a prescription, or for practitioners as “office stock.” The operation of 503B Outsourcing Facilities must conform to current Good Manufacturing Principles (cGMP) for pharmaceutical manufacturing. In contrast, traditional compounding pharmacies—now often called 503A Compounding Pharmacies after the section of the DQSA pertaining to them--compound medications solely for individual patients pursuant to a prescription, and are not held to cGMP standards.
What is the history of 503B outsourcing facilities?
Congress passed legislation – the DQSA – authorizing 503B facilities in response to a meningitis outbreak in New England that killed 64 people in 2012. The outbreak originated at a Massachusetts compounding pharmacy that shipped contaminated drugs to over 17,000 customers. At the time, regulation of compounding pharmacies was delegated to the states; the 2013 DQSA brought compounding pharmacies within the FDA’s regulatory authority. The DQSA introduced a new section 503B to the Food, Drug & Cosmetic Act that describes the conditions under which a compounding pharmacy can become an outsourcing facility. Similarly, in 2014, New York State adopted legislation authorizing 503B outsourcing facilities to operate within the state.
Are there restrictions on how a 503B outsourcing facility can compound animal drugs?
Compounded animal drugs must be made from FDA-approved animal or human drugs. Animal drugs, unlike human drugs, that are compounded from bulk material (i.e., materials that themselves are not FDA –approved drugs) are considered unapproved new drugs. However, we understand that some 503B outsourcing facilities take the position that the FDA does not intend to affirmatively enforce the prohibition on the use of bulk materials in animal drug compounding. We further understand that the FDA intends to release new draft guidance on the subject sometime in 2018. It has also been suggested that the FDA’s prohibition on animal drug compounding from bulk materials may be vulnerable to legal challenge. We note, however, that appellate courts considering the lawfulness of the FDA’s bulk materials regulations have routinely returned decisions favoring the government. Therefore, legal authority indicates that 503B outsourcing facilities may not compound animal drugs from bulk material.
Are veterinarians permitted to purchase compounded animal drugs from a 503B outsourcing facility?
Veterinarians are permitted to purchase compounded animal drugs from a 503B outsourcing facility provided that the facility is properly registered in New York State.
Are veterinarians authorized to administer compounded drugs that they purchased from a 503B outsourcing facility?
A veterinarian can purchase “office stock” from a 503B outsourcing facility, and is authorized to administer such stock medications to patients within the hospital/office setting.
Are veterinarians authorized to dispense (send the patient home with) compounded drugs that they purchase from a 503B outsourcing facility?
No, the New York Board of Pharmacy has indicated that “[p]roducts compounded by a 503B facility are not for resale and are for ‘office use’ only. They cannot be dispensed to a patient.”
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This information is educational and does not constitute legal advice.