FDA Attempts to Regulate Veterinary Compounding without ...

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Gives human compounding registered 503B outsourcing facilities the ability to ... provided for 503B outsourcing faciliti
FDA Attempts to Regulate Veterinary Compounding without Congressional Authority IACP seeks Congressional support to have FDA explain its recent attempt to regulate veterinary compounding through a guidance document in absence of clear legislative direction. FDA’s Draft Guidance Document Contradicts Existing Law and Practice On May 21, 2015, the Food and Drug Administration released a draft guidance document entitled Compounding Animal Drugs from Bulk Substances for public comment. The guidance document contains numerous instances of mandates upon compounding pharmacists and veterinarians which are not supported by existing federal law or Congressional intent and which contradict long-standing State authority to govern veterinary medicine use. Some examples of excessive regulatory overreach in this guidance document include:  

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International Academy of Compounding Pharmacists 1321 Duke Street, #200 Alexandria VA 22314 David G. Miller, R.Ph. EVP & CEO [email protected] (703) 299-0796 Cynthia Blankenship, Esq. Vice President, Government Affairs [email protected] (703) 299-0796

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Applies language in federal human compounding statute to veterinary compounding without authorization from Congress. Gives human compounding registered 503B outsourcing facilities the ability to prepare veterinary compounds without authorization from Congress. Congress specifically provided for 503B outsourcing facilities to prepare sterile compounds for human use. Requires a mandatory participation in an adverse event reporting program by pharmacists. Establishes an unreasonable 14-day supply limits on the amount of medication which can be compounded in anticipation of receiving a prescription. Mandates specific labeling requirements by pharmacists which are inconsistent with State law. Mandates specific wording to be included on a prescription by a veterinarian in contradiction to existing State authority over prescribing. Interferes in the professional decision making of veterinarians and pharmacists in the use of bulk ingredients (Active Pharmaceutical Ingredients) to achieve a desired therapeutic outcome.

As released by the FDA, it is clear to compounding pharmacists that the agency is attempting to circumvent both Congressional authority and the rights of States to regulate veterinary compounding practice. Despite repeated requests for an open, thoughtful process since the release of an “emergency” guidance document more than a decade ago, FDA again is proceeding to ignore stakeholder input and Congressional directives by promulgating this guidance document.

Key Points  The current FDA draft guidance document exceeds the agency’s authority granted by Congress.  FDA attempts to apply sections of the Drug Quality & Security Act for human compounding to veterinary care.  Proposed requirements contradict State authority to regulate and oversee veterinary and pharmacy practice.  If adopted, the guidance will have a significant impact on access to needed medications for animal care.

Supporting This Will  Demonstrate that the FDA does not have the power to create law in absence of Congressional direction.  Require the agency to fully engage stakeholders from pharmacy, veterinary medicine, and State regulatory Boards before creating a guidance document.  Prevent FDA from applying laws that were never intended to be used for veterinary compounding purposes.

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