DIRECTOR'S ORDER #77-4: USE OF PHARMACEUTICALS FOR WILDLIFE

Approved:

Effective Date:

Sunset Date:

[14-day review draft. Send comments to Margaret Wild by 7/21/02.]

Contents:

1. BACKGROUND
2. PURPOSE
3. AUTHORITY TO ISSUE THIS DIRECTOR'S ORDER
4. POLICY, REQUIREMENTS, AND RESPONSIBILITIES
4.1 Policy
4.2 Requirements
4.3 Responsibilities
5. ADDITIONAL GUIDANCE
__________________________________________________________

1. BACKGROUND

Natural resource management and research programs conducted in units of the National Park System may require administration of pharmaceuticals for wild animals. Pharmaceuticals commonly used in wildlife programs include anesthetic agents, antibiotics, vaccines, contraceptives, and anti-parasitic drugs. Many wildlife species cannot be safely restrained or handled without the use of pharmaceuticals. Pharmaceuticals are also used to treat or prevent non-native diseases or diseases resulting from human intervention, diseases that threaten at-risk species, or diseases of animals that threaten human health. Contraceptives may be applied to control wildlife populations.

Most of the pharmaceuticals used for wildlife are federally regulated to help safeguard human and animal health. National Park Service staff must possess adequate knowledge and experience in the use of pharmaceuticals for wildlife to assure human safety and to provide an adequate standard for professional care. The continued use of pharmaceuticals for wildlife is jeopardized if federal regulations or the public trust are violated.

The use of vaccines and other veterinary biologics is regulated by the Veterinary Biologics Staff, Animal Plant Health Inspection Service, U.S. Department of Agriculture. The use of other pharmaceutical agents in animals (i.e., animal drugs) is under the jurisdiction of the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act and the Food and Drug Administration Modernization Act of 1997. Additional guidance is contained in the Animal Medicinal Drug Use Clarification Act (AMDUCA) of 1994. These laws and their implementing regulations govern the prescription of animal drugs and the extra-label use of drugs. Extra-label (or off-label) use of drugs refers to the administration of an approved drug in a manner not in accordance with label directions. Extra-label use of drugs for wildlife is often required because the drugs are not licensed specifically for use in these species.

Further, many of the drugs used for wildlife, particularly field anesthesia, are controlled substances whose use is restricted by the Drug Enforcement Agency (DEA). Controlled substances are narcotics and other dangerous drugs that are classified into five groups based on their potential for abuse and ability to cause psychic or physical dependence. A high degree of proficiency is required to safely and effectively administer these drugs. The Controlled Substances Act, as amended, requires an individual/agency to have special DEA registration to purchase these controlled substances, and details requirements that govern recordkeeping and storage of controlled substances.

Finally, some pharmaceuticals, particularly contraceptives and new injectable anesthetics, are available for use prior to licensing to collect data that will be used in their registration. These products are regulated by FDA as Investigational New Animal Drugs (INADs). Use of INADs requires specialized authorization under a drug research project.

The care and use of animals in research is governed by the Animal Welfare Act. If pharmaceuticals are administered as part of a research project (e.g., to anesthetize animals for marking as part of a research project, administer a vaccine as part of a research project), requirements of the Animal Welfare Act, including protocol review and approval by an Institutional Animal Care and Use Committee (IACUC), apply. Wildlife management activities are not federally regulated. However, professional society standards do exist.

2. PURPOSE

The purpose of this Director's Order and the accompanying Reference Manual #77-4 is to establish NPS operational policies and procedures for compliance with existing federal laws, regulations, and guidelines governing the use of pharmaceutical agents for wildlife in the National Park System. NPS-77 Guidelines on Chemical Immobilization and Sterilization Agents and a memorandum dated March 7, 1994, regarding Service-wide Procedures for the Acquisition, Storage, and Use of Wildlife Immobilization and Anesthetic Drugs are superceded and replaced by this Director's Order and Reference Manual #77-4.

3. AUTHORITY TO ISSUE THIS DIRECTOR'S ORDER

The authority to issue this Director's Order and the associated Reference Manual is contained in 16 USC 1 through 4 (the National Park Service Organic Act) and the delegations of authority contained in Part 245 of the Department of the Interior Manual.

Other legal and regulatory requirements are contained in the:
· Federal Food, Drug, and Cosmetic Act, as amended by the Food and Drug Administration Modernization Act of 1997 (21 USC Ch. 9);
· New Animal Drugs for Investigational Use, as amended by the Animal Medicinal Drug Use Clarification Act (AMDUCA) of 1994 (21 USC 360(b));
· Controlled Substances Act (21 USC 801; regulations published at 21 CFR 1301); and
· Animal Welfare Act (7 USC 2131; regulations published at 9 CFR 1.1 to 12.10).

4. POLICY, REQUIREMENTS, AND RESPONSIBILITIES

This Director's Order sets forth the policy, requirements, and responsibilities for administration or application of pharmaceuticals to wildlife within units of the National Park System.

   4.1 Policy

The administration of pharmaceuticals to wildlife is a necessary component of some management and research activities conducted in the NPS. It is our policy to administer pharmaceuticals to wildlife in a manner that is safe for humans and animals, adheres to humane standards, and is in accordance with NPS wildlife management philosophy. To implement this policy, NPS employees will comply with all provisions of Director's Order #77-4.

   4.2 Requirements

For the safe and responsible use of pharmaceuticals for wildlife, the National Park Service will:

        A. Comply with FDA regulations on the use of drugs in animals.

             1. Prescription Drugs
Nearly all drugs used for wildlife are prescription drugs. Veterinary prescription drugs are restricted to use by or on the order of a licensed veterinarian under a valid veterinarian-patient-client relationship. In the case of the NPS, this relationship triad consists of wildlife (any wild or feral free-ranging vertebrate species) as the patient, a resource manager or scientist as the client, and NPS staff veterinarian or consulting veterinarian (e.g., qualified local practitioner, federal or state agency veterinarian) as the veterinarian of record. This formal relationship establishes that a licensed veterinarian assumes the responsibility for making medical judgments regarding the health of the animal(s) and the need for medical treatment, and the client (NPS) agrees to follow the instructions of the veterinarian. The veterinarian does not have to be on site during use of the drugs, but he or she must be familiar with the species, herd, or local population, and if possible the individual animal treated. This requirement may be most efficiently and effectively met through the use of protocols approved by the veterinarian of record.

             2. Extra-label Use of Drugs
If a labeled drug that fully meets the need is available for use, it should be used (must be used in food-producing animals). However, most drugs administered to wildlife are applied on an extra-label basis. AMDUCA specifies additional requirements for the extra-label use of drugs. These include:

a. Well-defined records that are maintained for two years:
   (1) The established name of the drug and its active ingredient.
   (2) The condition treated (e.g., capture for radio collaring).
   (3) The species treated.
   (4) The dosage administered.
   (5) The duration of treatment.
   (6) The number of animals treated.
   (7) The specified withdrawal time for drugs used in food animals (animals that may be harvested for human consumption).

b. Labeling requirements:
   (1) Name and address of prescribing veterinarian.
   (2) Established name of drug.
   (3) Directions for use.
   (4) Cautionary statements.
   (5) Withdrawal time for human consumption of food products from treated animals.

c. Exclusion of the treated animal from the human food chain until the drug withdrawal time is met. Wildlife species that receive prescription drugs and may be consumed by humans must be identified. These identifying markers are used to notify individuals that may harvest the animal not to consume meat until the specified drug withdrawal time has elapsed. Coordination with state wildlife management agencies is encouraged to identify potential "food-producing" animals (those that may be harvested for meat).

             3. Compounding Animal Drugs
Compounding is defined as any manipulation to produce a dosage-form drug other than that provided for in the directions for use (e.g., freeze-drying a drug for reconstitution at a higher concentration). Compounding from approved drugs by veterinarians and pharmacists (acting on a valid prescription) is allowed under certain circumstances. The NPS will comply with FDA regulations on compounding and specifically will not use compounded drugs freeze-dried by sources other than a veterinarian or pharmacist within the confines of a legitimate practice.

        B. Comply with FDA regulations and the sponsor's instructions on use of Investigational New Animal Drugs.

Records on the use of INADs will be submitted to the sponsor, and all other FDA reporting requirements (as defined in 21 CFR 511) will be met.

        C. Promote humane use of pharmaceuticals for wildlife.

NPS will comply with the Animal Welfare Act if pharmaceuticals are used in animals on research projects. NPS will comply with acceptable humane standards and professional society guidelines for the use of pharmaceuticals in management activities.

        D. Require firearms training and qualification for individuals who perform remote delivery of pharmaceuticals.

Remote delivery systems for pharmaceuticals (e.g., dart guns, biobullet guns) are considered firearms by the NPS. All employees whose duties require the use of firearms must qualify, at a minimum, semi-annually with the type(s) of firearm(s) used. Firearms training must include safety, marksmanship, maintenance, storage, performance, limitations of weapons, accountability and control, and security. Park managers are delegated authority to establish qualification courses for the use of remote delivery systems. Park managers in consultation with the park's firearms officer and natural resources manager or scientist will establish approved courses of fire for qualification with these firearms based on specific needs and uses. Park Superintendents or Regional Managers may grant certification to NPS cooperators (e.g., state or other federal agency staff) based on the cooperating agency's requirements.

        E. Authorize only well-qualified individuals to administer pharmaceuticals.

Prescription drugs are regulated because of their toxicity or other potential for harmful effects. Through compliance with FDA regulations and establishment of a valid veterinarian-patient-client relationship, adequate information to safely and effectively administer non-controlled pharmaceuticals should be provided by the veterinarian to the client.

In addition to the above, for the safe and responsible use of anesthetics or controlled substances for wildlife, the National Park Service will:

        F. Comply with DEA regulations on use of controlled substances.

NPS units with a need to directly acquire or store anesthetics or controlled substances, or to administer them to wildlife, will appoint a park practitioner. Park practitioners may obtain controlled substances from an individual holding an appropriate DEA license (e.g., a veterinarian) or may register directly with the DEA. Each park, Regional Support Office, or Washington Support Office (WASO) location with a need to directly purchase controlled substances must obtain a DEA Controlled Substance Registration (use DEA Form 225: Application for Registration as a Researcher). Each registration will be issued under the name "NPS," followed by the name of the park. The name of the park practitioner will appear on line two of the registration. The registration for each NPS unit is intended for wildlife management and research activities only. Although non-veterinarians licensed by the DEA may purchase controlled substances, their use is prohibited without first establishing a valid veterinarian-patient-client relationship. Security and storage requirements for controlled substances will be in compliance with 21 CFR 1301.71 to 1301.76; recordkeeping will be in compliance with the DEA requirements under 21 CFR 1304, and the requirements under 21 CFR 1305 regarding DEA Official Order Forms.

        G. Require certification of individuals to administer anesthetics or controlled substances to wildlife.

Many anesthetics and controlled substances are potentially lethal to humans if accidental exposure occurs. Further, controlled substances and techniques used for field anesthesia pose a concern for animal welfare. Therefore, all NPS employees, agents, or cooperators who use anesthetics or controlled substances for wildlife management or research purposes must obtain certification in accordance with requirements described in Reference Manual #77-4. Certification will be obtained through completion of training programs or demonstration of appropriate knowledge, experience, and skills in wildlife anesthesia and administration of controlled substances (e.g., pharmacology, human safety, animal safety and humane standards, techniques of field anesthesia, euthanasia). Superintendents or Regional Managers may grant certification to NPS cooperators (e.g., state or other federal agency staff) based on the cooperating agency's requirements.

        H. Require protocols for the use of anesthetics or controlled substances for wildlife.

Protocols for the use of anesthetics or controlled substances for wildlife will be developed. These protocols will include the objectives of the program, methodology, and safety procedures. In the case of research projects, this would be accomplished through the use of an Institutional Animal Care and Use Committee (IACUC) approved study protocol. Use of blanket protocols for routine management activities (e.g., nuisance animals, transplantations) is encouraged. Protocols will be approved by the park superintendent or Regional Manager, and by the veterinarian of record.

   4.3 Responsibilities

        A. Director

1. Sets forth Service-wide policy on the safe and responsible use of pharmaceuticals in the NPS.
2. Issues Director's Orders to meet human safety, animal safety, and humane standards for wildlife management activities in the NPS.

        B. Regional Director

1. Ensures that standards are uniformly applied to all parks within the region.
2. Ensures that funds are available commensurate with demands and needs for veterinary consultation and staff training and certification.

        C. Regional Program Manager

1. Ensures that programs planned or supervised from the regional office use trained and certified employees with appropriate veterinary consultation.

        D. Superintendent

1. Ensures that Director's Orders and Reference Manual #77-4 are incorporated programmatically into park operations.
2. Except where otherwise established, approves personnel as qualified to perform duties for which certification is available.
3. Approves, or delegates to IACUC approval, protocols for the use of anesthetics or controlled substances for wildlife in the park.

        E. Resource Manager

1. Plans and implements wildlife programs in a safe, effective, and humane manner, in part by developing protocols for the use of anesthetics or controlled substances for wildlife.
2. Obtains training and certification for self and those under his/her supervision.
3. Establishes, or delegates to park practitioner, veterinarian-patient-client relationship for use of pharmaceuticals.

        F. Park Practitioner

1. Obtains training and certification on the use of pharmaceuticals.
2. Obtains substantial experience on the use of anesthetics and controlled substances in animals.
3. Establishes veterinarian-patient-client relationship.
4. Ensures that all controlled substance activities carried out are in compliance with all DEA regulations and requirements.

        G. NPS Staff Wildlife Veterinarian

1. Recommends policy on the use of pharmaceuticals in the NPS.
2. As requested by parks or regions, provides technical assistance (consultation or on-site assistance) on the use of pharmaceuticals for disease treatment and prevention, anesthesia, euthanasia, and other veterinary applications.
3. As requested by parks or regions, provides training, or assists in identifying training opportunities, for NPS staff and collaborators to obtain required certification for the use of anesthetics or controlled substances for wildlife in units of the National Park System.
4. As requested by parks or regions, serves as veterinarian of record, or assists in developing a relationship between the park and a consulting veterinarian.

5. ADDITIONAL GUIDANCE

The Associate Director, Natural Resource Stewardship and Science, will prepare and issue Reference Manual #77-4, which may provide additional technical guidance, procedures, detailed explanation of program areas, and requirements. Until Reference Manual #77-4 is issued, any provisions of the Natural Resources Management Guideline (NPS #77) not inconsistent with this Director's Order will be in place.

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