By Karla L. Palmer –
In addition to FDA’s request for nominations for bulk substances that may be used by outsourcing facilities for compounding animal medications (here) and draft guidance on compounding animal drugs from bulk substances (here), FDA also announced earlier this week that it is seeking comments on specific issues raised by compounding animal drugs. The topics FDA raises run the spectrum of potential issues that could arise (and many of which have arisen) concerning drug compounding generally. FDA asked for comments on these specific topics; as the saying goes, interested parties should “speak now . . . :”
- Should the final guidance address the issue of FDA-approved animal and human drugs that are in shortage or are otherwise unavailable (e.g., disruptions in the manufacture or supply chain; business decisions to stop marketing the drug; drug is subject to Agency action based on safety, effectiveness, or manufacturing concerns)? If so:
- How should these situations be addressed in the final guidance?
- How should the final guidance define the terms “shortage” and “unavailable”?
- What criteria should FDA use to determine if an approved animal or human drug is in shortage or otherwise unavailable?
- Do USP/NF chapters <795> and <797> provide suitable standards for animal drugs compounded by veterinarians, and if not, what standards of safety, purity, and quality should apply to animal drugs compounded by veterinarians?
- Should licensed veterinarians be able to sell or transfer an animal drug compounded from bulk drug substances by a state-licensed pharmacy or an outsourcing facility to owners or caretakers of animals under the veterinarian's care?
- How should FDA apply the condition to identify an individual patient when it is not possible to identify an individual animal (e.g., koi in a koi pond)?
- Should the final guidance include a condition on the amount/percentage of compounded animal drugs that a pharmacy/outsourcing facility can ship interstate? If so, what would a reasonable amount be?
- Should facilities registered as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) be able to compound animal drugs from bulk drug substances that do not appear in Appendix A for an individually identified animal patient under conditions similar to those applicable to state-licensed pharmacies (i.e., the conditions contained in section III.A. of the draft guidance)?
- Is additional guidance needed to address the repackaging of drugs for animal use?
- How widespread is the practice of repackaging drugs for animal use?
- What types of drugs are repackaged for animal use, and why are they repackaged?
- Have problems been identified with repackaged drugs for animal use?
- Is additional guidance needed to address the compounding of animal drugs from approved animal or human drugs under FDCA § 512(a)(4) or (a)(5) and 21 C.F.R. pt. 530?
- Is additional guidance needed to address the compounding of animal drugs from bulk drug substances for food-producing animals?
- As one condition under which FDA does not generally intend to take action for certain violations of the FDCA if this and the other conditions are followed, FDA is proposing that state-licensed pharmacies and veterinarians report any product defects or serious adverse events associated with animal drugs they compound from bulk drug substances to FDA within 15 days of becoming aware of the product defect or serious adverse event. Outsourcing facilities are required to report adverse events associated with the drugs they compound. FDA believes it is important to receive this information from state-licensed pharmacies and veterinarians because there are no other State Departments of Health or Federal Agencies (e.g., the Centers for Disease Control and Prevention) charged with identifying and tracing animal injuries or disease associated with an animal drug compounded by these entities. FDA has the following specific questions with respect to this proposed condition:
- How many state-licensed pharmacies and veterinarians compound animal drugs from bulk drug substances and would potentially be reporting product defects and serious adverse events to FDA?
- Are state-licensed pharmacies and veterinarians reporting the same or similar information to any state regulatory agency (e.g., state boards of pharmacy, state boards of veterinary medicine)? If so, how many reports on average does each state-licensed pharmacy and veterinarian submit to these state agencies each year?
- For purposes of the guidance, how should FDA define the terms “product defect” and “serious adverse event”?
- Can FDA achieve the same objective of identifying and tracing the source of injuries or disease associated with an animal drug compounded from a bulk drug substance through means other than product defect and serious adverse event reporting, and if so, what other means? For example, would reports of product defects alone achieve the same objective?
Comments may be submitted at any time, but to ensure FDA considers comments prior to finalizing guidance, they should be submitted within 90 days of publication of the request for comments in the Federal Register, or by August 17, 2015.