Exempt Biologics

Comment on this policyState-Licensed Veterinarians may consider preparing biologics in their practice facility under a Veterinarian-Client-Patient Relationship in unique disease situations not adequately covered with USDA licensed biologics or autogenous products made at a USDA licensed establishment.

Preparation of exempt biologics is permitted by the Virus Serum Toxin Act (21 USC 151-159) (VSTA), specifically in paragraph 154a.  The Secretary may exempt by regulation from the licensure and establishment requirements the preparation of any virus, serum, toxin, or analogous product prepared by any person, firm, or corporation (2) solely for the administration to animals under a veterinarian-client-patient relationship in the course of the State licensed professional practice of veterinary medicine. The regulation for exempt veterinary biologics is found in Chapter 9 of the Code of Federal Regulations Part 107 (9CFR 107.1).

9CFR 107.1(a) permits exempt veterinary biologics to be prepared by veterinarians in the following conditions:

  1. Prepared by a state licensed veterinarian.
  2. Administered solely to animals covered in the USDA-defined Veterinarian-Client-Patient Relationship (VCPR).
  3. All steps in preparing the biologic must be performed in the facilities that the veterinarian utilizes for day-to-day activities associated with the treatment of animals in the course of the state-licensed practice of veterinary medicine.  The preparation may not be consigned to any other party or subcontracted to a commercial laboratory or manufacturing facility.
  4. Records shall be maintained by the veterinarian and made available to USDA that are necessary to establish a VCPR and there is valid basis for the exemption.
  5. The Administrator may require the veterinarian to provide information prior to shipment of exempt biologics containing live organisms.

Before preparing biologics for use in their practice, veterinarians are encouraged to check with their malpractice insurance provider to determine whether the preparation of biologic products is covered under their professional liability insurance policy and/or whether it is advisable to obtain separate product liability coverage.

Exempt products under 9CFR 107.1 have the following characteristics to keep in mind when considering the preparation of such products:

  1. Exempt production of biologics is not exempt from enforcement of the VSTA.
  2. Practices preparing exempt biologics are not exempt from USDA inspection and record review.
  3. Exempt biologics products are not exempt from being potent, pure, safe, and efficacious.
  4. The veterinarian is permitted to utilize various sources of organisms.  The veterinarian is advised to contact CVB when the organism is not from the herd of origin.  Adequate records must be kept to demonstrate all steps of preparation, test results, and distribution.
  5. May be subject to State regulations and approval.
  6. Must not interfere with official disease control/eradication programs/efforts.
  7. Any exempted product which is worthless, contaminated, dangerous, or harmful is prohibited, and any person shipping such product, or delivering such product, shall be subject to sanctions under the VSTA.

Standards for the preparation should be sufficient to:

  1. Prepare and distribute safe, pure product.
  2. Give evidence of a reasonable expectation of potency and efficacy.
  3. Show labeling that is truthful, complete, and accurate (including dosage, route of administration, and directions).
  4. Show date of production and storage conditions.
  5. Provide contact information for the preparing veterinarian on the label.