With the great variety of different types and sizes of animals, the pharmaceutical industry is unable to mass produce appropriate medication that is suitable for each type of condition that pets and non-food producing animals face. As a result, veterinary compounding pharmacies have traditionally filled a much-need role in providing needed and tailored medication, when a commercially-available drug with a New Animal Drug Application (NADA) or Abbreviated New Animal Drug Application (ANADA) do not exist. The result, of course, is that these firms face a veritable web of differing, and often unclear, regulatory frameworks and legal issues.
Frier Levitt has assisted veterinary compounders for over ten years with a multitude of legal issues. Frier Levitt has several pharmacist-attorneys, who are able to effectively utilize clinical knowledge in providing legal advice and assistance to our clients. We understand the issues that are central to our veterinary compounding clients, as well as the legal and regulatory solutions.
Background
Compounding is generally defined as the mixing of two or more ingredients or drug products to create a new drug product, but may also include any manipulation of a drug beyond that which is specified on the drug’s label. This could include mixing, diluting, concentrating, flavoring, or changing a drug’s dosage form, as well as combing multiple drug products into a single finished dosage.
In the veterinary space, the Food and Drug Administration (FDA) issues New Animal Drug Applications (NADA) to new drugs for animals that meet certain FDA standards for approval. The FDA will also issue Abbreviated New Animal Drug Applications (ANADA) for generic versions of approved animal drugs. These products are listed in the Green Book, and there are currently over 4,300 products with an NADA or ANADA.
However, because of the vast multitude of different types of animals, sizes, and breeds, it is not always practicable for commercial products to be mass produced and still meet every need. To that end, animal compounding has continued to play a major role in the care of pets, horses and other non-food producing animals.
FDA Compliance
The practice of veterinary compounding is regulated by both the FDA and state governments. At a federal level, as opposed to compounding human drugs (which is specifically addressed by the Drug Quality and Security Act of 2013), the FDA does not have an explicit statutory framework addressing the practice of veterinary compounding. Instead, the primary set of rules that the FDA utilizes in regulating veterinary compounding is within its Extralabel Drug Use (ELDU) rules.
While the FDA has said that it generally defers day-to-day oversight and enforcement of veterinary compounding to applicable state authorities (i.e., Boards of Pharmacy or Veterinary Medical Examiner Boards), these Federal extra label drug use regulations specifically permit compounding from FDA-approved drugs when a veterinarian believes there is a need to alter the approved drug to adequately medicate a non-food animal with a diagnosed medical condition.
The hallmark of the FDA’s regulatory framework is the concept of an established veterinarian-client-patient relationship (VCPR). In this space, the FDA has suggested that it might undertake enforcement action if compounding firms engaged in conduct that went beyond traditional pharmacy practices, such as using commercial-scale equipment to compound in large quantities or compounding large quantities not intended for use for a specific patient.
State Board of Pharmacy Requirements
At a state level, state Boards of Pharmacy oversee licensed pharmacy practices within their respective states, while the state Boards of Veterinary Medical Examiners oversee the practice of veterinary medicine. State laws vary on the ability of veterinarians to order compounded medications for administration to patients in the course of their practice (i.e., office use), and for pharmacies to provide such products for in-office administration. Many states also require pharmacies to adhere to the United States Pharmacopeial Convention (USP) standards related to pharmacy compounding, including Chapters <795> and <797>, related to non-sterile and sterile compounding, respectively.
Failure to adhere to these standards can lead to inspection by the relevant Boards, and ultimately, disciplinary action.
Veterinary Compounding for Office Use
One area within veterinary compounding that has experienced a tremendous amount of focus is the practice of “office use” compounding. Compounding for “office use” involves a scenario where the medication is compounded by the pharmacy, and then sold to a veterinarian, who then administers directly to the patient. Sometimes, the compounding pharmacy may provide the compounded product to the veterinarian, who then dispenses or resells the product to the owner of the animal.
This practice is extraordinarily prevalent in the veterinary marketplace, and the current federal and state laws are unclear at best, and often times are in conflict with one another. While the Drug Quality and Security Act of 2013 explicitly prohibited office use compounding unless performed by a registered Outsourcing Facility, none of the regulation or guidance promulgated by Congress or the FDA squarely addressed the issue of veterinary office use compounding. At the same time, many states have laws on the books that explicitly permit office use compounding, sometimes making no distinction between human and animal drugs, and sometimes explicitly permitting it for veterinary medications only.
As a result, veterinary compounding pharmacies must make strong efforts to understand and comply with the specific “office use” laws for each state into which they distribute compounded veterinary medications.
Bulk Drug Products
Among the murkiest of rules applicable to veterinary compounders is the ability to compound using bulk drug ingredients, or active pharmaceutical ingredients (APIs). Bulk APIs are raw drugs in pure chemical form, that can be used to create a finished dosage form. Bulk APIs are not FDA-approved (although they may be components of FDA-approved drugs).
In its extralabel drug use rules (the regulations written to implement the Animal Medicinal Drug Use Clarification Act (AMDUCA)), the FDA has continued to assert that compounding should be performed using FDA-approved drugs (even if it involves the off label use of an approved animal or even human drug).
However, there are many instances where an approved drug is not commercially available (including by reason of a drug shortage), or the patient requires a compounded formulation that cannot be made from approved drugs.
As a result, in guidance and other pronouncements, the FDA has recognized medical need for compounding from bulk ingredients in certain areas of veterinary practice. It is important to consult with these evolving and everchanging guidances, directives and enforcement directives when considering whether to compound using bulk APIs
How Frier Levitt Can Help
• Assistance with FDA inspections and enforcement defense
• Assistance with State Board of Pharmacy inspections and enforcement defense
• Assistance with third party accreditation (including Pharmacy Compounding Accreditation Board)
• Defense of DEA enforcement actions
• Adverse events reporting and product recalls
• Review of preprinted prescription pads and marketing materials
• M&A
• Advice and assistance in structuring marketing arrangements
Frier Levitt provides strategic, industry-focused legal counsel tailored to your needs. Contact our team today to learn how we can help you.