Contents

SUBCHAPTER 580 - VETERINARY MEDICINE

580 - CVM WEBSITE

The Center for Veterinary Medicine has its own website. The website contains an alphabetical listing of topics under "Index"; a listing of current and planned Guidance Documents; and on line access to the "GreenBook" database listing animal drug approvals. There is a "search" feature allowing you to search for documents containing various words or phrases. The website also contains organizational information for the Center and an explanation of the various laws and regulations which the Center enforces. Information on the website can provide guidance for inspectional efforts related to CVM obligations.

581 - VETERINARY DRUG ACTIVITIES

CVM is responsible for inspections of therapeutic and production drugs, and Active Pharmaceutical Ingredients (APIs). Therapeutic drugs are used in the diagnosis, cure, mitigation, treatment or prevention of disease. Production drugs are used for economic enhancement of animal productivity. Examples include: growth promotion, feed efficiency and increased milk production.

Preapproval inspections are conducted pursuant to pending NADA or ANADA applications.

Post approval inspections of veterinary drugs are conducted to determine compliance with the Current Good Manufacturing Practices (CGMPs) for Finished Pharmaceuticals under 21 CFR Part 211. These cGMPs apply to both human and veterinary drugs. Information on veterinary drugs approved can be found in the "Greenbook" database accessed through CVM's website.

API's are active pharmaceutical ingredients. Many of the APIs used to manufacture dosage form drugs are imported from foreign countries. The intended source for an API must be indicated in NADA/ANADA submissions for new animal drug approvals. Any change in a source for an API would require a supplement to the application.

Extra label drug use refers to the regulations in 21 CFR Part 530 codified as a result of the Animal Medicinal Drug Use Clarification Act (AMDUCA) of 1994. These regulations set forth the requirements for veterinarians to prescribe extra label uses of certain approved animal and human drugs and the requirements for the existence of a valid veterinarian/client/patient relationship (VCPR). The regulations under 21 CFR Part 530 address issues regarding extra label use in non-food as well as food producing animals. 21 CFR 530.41 contains a list of drugs that cannot be used in an extra label fashion in food-producing animals. During an inspection or investigation if you encounter any situations on extra label use of the listed drugs, you should contact CVM's Division of Compliance (HFV-230) (301-827-1168).

The regulations under 21 CF Part 530 also address compounding of products from approved animal or human drugs by a pharmacist or veterinarian. The regulations clearly state compounding is not permitted from bulk drugs. This would include APIs. CVM has an existing CPG on Compounding of Drugs for Use in Animals (CPG 7125.40; Chapter 608.400). A copy can be found on CVM's website. The Division of Compliance (HFV-230) has issued assignments to conduct inspections of firms, including internet pharmacies, who may be engaged in the practice of manufacturing under the guise of pharmacy compounding. You should contact the Division of Compliance (HFV-230) at 301-827-1168 to report instances of compounding or to seek guidance on inspectional issues, or regulatory and enforcement policies.

582 - MEDICATED FEEDS AND TYPE A ARTICLES

Animal feed is defined under section 201(w) of the FD&C Act [21 U.S.C. 321 (w)]. CVM is responsible for control of medicated and non-medicated animal feeds, Type A medicated articles and pet foods.

The regulations for animal food labeling are in 21CFR Part 501. The regulations for medicated feed mill licensure are in 21CFR Part 515. The cGMPs for Medicated Feeds are in 21CFR Part 225. The cGMPs for Type A Articles are in 21 CFR Part 226.

Inspections are routinely conducted of medicated feed mills and manufacturers of Type A Medicated Articles.

If you have questions related to cGMPs and enforcement policies and strategies concerning Medicated Feeds and Type A Articles you should contact the CVM/Division of Compliance (301-827-1168).

Guidance on pet food labeling requirements can be found on CVM's website.

583 - BSE ACTIVITIES

CVM is responsible for FDA's educational and regulatory activities involving BSE. BSE is "Bovine Spongiform Encephalopathy" and is often referred to as "mad cow disease." BSE information can be found on the CVM website. CVM has four Guidance Documents in place dealing with BSE (67-70, dated February 1998). The Guidance Documents address renderers, protein blenders, feed manufacturers, distributors and on farm feeders.

Questions on inspectional assignments and regulatory activities in the BSE area should be addressed to the CVM/Division of Compliance (HFV-230) at 301-827-1168.

584 - TISSUE RESIDUES

The presence of violative drug residues in food from slaughtered animals is a human health concern. Tissue residue investigations/inspections are performed in response to reports of violative drug residue levels found in tissue sampled at slaughter by the USDA.

Tissue residues are commonly caused by the medication of animals prior to marketing and failure to follow the withdrawal times. When a new animal drug is approved the manufacturer must conduct studies to accurately determine withdrawal times. Allowable tolerances for residues of new animal drugs in food can be found in 21CFR Part 556.

For information on tissue residue violations and activities you should contact the CVM/Division of Compliance (HFV-230, 301-827-1168).

585 - VETERINARY DEVICES

Medical devices for animal/veterinary use are not subject to the premarket approval requirements like human medical devices. Once an animal use device is marketed the Center is concerned with safety and efficacy of the veterinary device. CVM often recommends firms use the human device GMPs in controlling the manufacturing of animal use devices. CVM also suggests labeling be sent in for review by the Division of Compliance (HFV-230) to avoid misbranding. Regulatory questions for veterinary/animal use devices should be directed to the CVM/Division of Compliance (HFV-230).

586 - ANIMAL GROOMING AIDES

Cosmetic articles intended to cleanse and beautify animals are referred to as "animal grooming aides." The definition of "cosmetic" under section 201(I) of the FD & C Act [21 U.S.C. 321 (I)] refers only to use of such articles in humans and does not include products for animal use.

If animal grooming aides are labeled with either direct or implied therapeutic claims, however, they may be considered as drugs under section 201(g) of the FD&C Act [21 U.S.C. 321 (g)] or even as new animal drugs under section 201(v) of the FD&C Act [21 U.S.C. 321(v)].

Grooming aides formulated only to cleanse or beautify animals are not subject to the provisions of the Act. However, the Center is still concerned over the safety of such products and tracks complaints and adverse reactions.

Questions on labeling and regulatory concerns should be directed to the Division of Compliance (HFV-230). To report complaints or adverse reactions involving animal grooming aides or to determine the complaint history of a particular product you should contact the Division of Surveillance (HFV-210).

587 - CVM BIO-RESEARCH MONITORING

CVM issues assignments to the field to conduct BiMO inspections of animal drug studies, including both therapeutic and production drugs. Currently, there is no requirement for animal drug studies to be controlled by any sort of institutional review board (IRB). See IOM 545.