Compounding comments dominate FDA notice

by Ben Williams

The U.S. Food and Drug Administration (FDA) has extended the deadline for comments on how to increase the number of approved veterinary drugs on the market. Meanwhile, pleas for the FDA to not shut down compounding pharmacies continue to flood in, even though the agency says it is not planning any such action.

The FDA published a notice in the Federal Register in December, saying it wants to find ways in which it can make more drugs legally available to veterinarians and pet owners. The notice cites the large number of non-FDA-approved animal drugs that are available, and asks for strategies on how to address the issue.

The agency has already received close to 200 comments on the notice, and they have extended the comment period from Feb. 18 to April 19, in response to several calls for an extension.

Interestingly, many of the scores of comments from pharmacies, veterinarians and other industry personnel are appeals to the FDA to not crack down on compounding pharmacies.

"Many medications that are approved for a species may not be otherwise available in appropriate sizes for very large and especially very small animals," wrote one veterinarian. "Therefore I request that before you start enforcing such bans please come up with a plan that provides veterinarians with the compounding tools they require and need to relieve and treat animal suffering and disease."

In fact, the FDA is not proposing a ban on compounders, rather it is attempting to find a way to bring unapproved drugs into the realm of legal, FDA-approved products. An FDA spokeswoman said that while compounding pharmacies are on the agency’s radar as providing unapproved drugs to the market, the notice was not meant as an attack on compounders.

"Unapproved new animal drugs are manufactured and distributed by a variety of firms, among them traditional drug manufacturers, compounding pharmacies, and supplement manufacturers," said Laura Alvey, the FDA’s Center for Veterinary Medicine deputy communications director. "The notice does not reflect FDA concerns regarding any particular types of firms or unapproved new animal drug products.  Rather FDAs goal is to increase the availability of approved, indexed, or otherwise legally marketed new animal drugs, with the assurances of safety, effectiveness, and quality that these processes provide."

‘Enforcement discretion’ on the table

According to the notice, the agency is willing to consider avenues not only within its existing regulatory framework, but also new ideas on how to make certain drugs legally available. The FDA also wants to hear comments about the use of "enforcement discretion" as a means to this end. If the agency uses enforcement discretion, it basically means they will look the other way and not shut down a company for selling an unapproved drug if that drug is essential to an animals health.

The Society of Veterinary Hospital Pharmacists (SVHP) is preparing to submit comments to the FDA, said Gigi Davidson, RPh, DICVP, Director of Clinical Pharmacy Services at North Carolina State University’s College of Veterinary Medicine. Davidson agrees that the notice has nothing to do with traditional compounding pharmacies, but the SHVP is planning to weigh in on ways the FDA can cut down illegal compounding, while using enforcement discretion in legitimate cases.

Specifically, the SVHP is suggesting the FDA:

  • Develop criteria for a new separate category of FDA-sanctioned veterinary products, tentatively called: Medically Necessary Veterinary Drugs (MNVDs). This category would encompass products that currently do not readily fall into the current established categories (New Animal Drug, Conditionally- Approved New Animal Drug, etc.)
  • Streamline the current approval process for new animal drug products by use of publicly available information (such as peer-reviewed literature and USP monographs)
  • Clarify the professional and legal liability of prescribing these temporarily and conditionally approved new animal drugs by veterinarians
  • Develop outreach programs to veterinarians and pharmacists to educate veterinary professionals regarding unapproved drugs
  • Establish a criterion that clearly distinguishes illegitimate unapproved manufactured drugs from legitimate compounded drugs that are prepared for an individual veterinary patient.

On the last point, the SVHP elaborates that they are "extremely concerned" about the increasing number of companies that manufacture compounds for sale to veterinary practices as inventory to be resold. However, the use of enforcement discretion should be encouraged where compounds are used in the way they were intended, the SVHP argues.

"While FDA has stated that they consider compounds to be unapproved animal drugs, SVHP believes that compounds prepared for an individual patient (or for bona fide office use in states that allow) pursuant to a legitimate prescription from a licensed veterinarian within the VCPR [veterinarian-client-patient relationship] should not be treated like unapproved drugs or regulated by FDA, but are clearly within the traditional practice of pharmacy and should remain regulated by state boards," the statement says.

To leave a comment or read the comments of others on the FDAs notice, visit and search for Docket No. FDA-2010-N-0528.

NEWStat Legislation & regulation