Source: http://www.vetmed.ucdavis.edu/clinicaltrials/investigators/drugs.cfm
Timestamp: 2016-02-07 08:31:33
Document Index: 359859218

Matched Legal Cases: ['art 3', 'art 3', 'art 3', 'art 500', 'art 511', 'art 16', 'art 511', 'art 299', 'art 530']

Investigational Drugs | UC Davis School of Veterinary Medicine | Clinical Trials
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Most journals will not accept an article advocating the use of a drug clinically when it is made from bulk ingredients (i.e., raw chemical). When a drug is made commercially, the researcher should use the commercial preparation (e.g., tab, cap, oral solution, etc) to do the investigation. Yes, it is more expensive; however, you don't want a journal to reject your publication because of the source of the drug!
See the American Veterinary Medical Association (AVMA)'s viewpoint on Compounding: "Compounding: Are you following the rules?" (PPT).
Drugs Administered at the Owner's Home
2013 Lawbook for Pharmacy (PDF)
Chapter 9, Division 2 Article 4: Requirements for Prescriptions Prescription Container - Requirements for Labeling
Section 4076
Except where the prescriber or the certified nurse-midwife who functions pursuant to a standardized procedure or protocol described in Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1, or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to either Section 4052.1 or 4052.2 orders otherwise, either the manufacturer's trade name of the drug or the generic name and the name of the manufacturer. Commonly used abbreviations may be used. Preparations containing two or more active ingredients may be identified by the manufacturer's trade name or the commonly used name or the principal active ingredients.
The directions for the use of the drug.
The name of the patient or patients.
The name of the prescriber or, if applicable, the name of the certified nurse-midwife who functions pursuant to a standardized procedure or protocol described in Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1, or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to either Section 4052.1 or 4052.2.
The name and address of the pharmacy, and prescription number or other means of identifying the prescription.
The strength of the drug or drugs dispensed.
The quantity of the drug or drugs dispensed.
The expiration date of the effectiveness of the drug dispensed.
The condition or purpose for which the drug was prescribed if the condition or purpose is indicated on the prescription.
Commencing January 1, 2006, the physical description of the dispensed medication, including its color, shape, and any identification code that appears on the tablets or capsules, except as follows: Prescriptions dispensed by a veterinarian.
An exemption from the requirements of this paragraph shall be granted to a new drug for the first 120 days that the drug is on the market and for the 90 days during which the national reference file has no description on file.
Dispensed medications for which no physical description exists in any commercially available database.
This paragraph applies to outpatient pharmacies only.
The information required by this paragraph may be printed on an auxiliary label that is affixed to the prescription container.
This paragraph shall not become operative if the board, prior to January 1, 2006, adopts regulations that mandate the same labeling requirements set forth in this paragraph.
(c) If a pharmacist dispenses a dangerous drug or device in a facility licensed pursuant to Section 1250 of the Health and Safety Code, it is not necessary to include on individual unit dose containers for a specific patient, the name of the certified nurse-midwife who functions pursuant to a standardized procedure or protocol described in Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1, or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to either Section 4052.1 or 4052.2.
Dispensing Dangerous Drug in Incorrectly Labeled Container
Section 4077
(c) Devices that bear the legend "Caution: federal law restricts this device to sale by or on the order of a _____," or words of similar meaning, are exempt from the requirements of Section 4076, and Section 111480 of the Health and Safety Code, when provided to patients in skilled nursing facilities or intermediate care facilities licensed pursuant to Chapter 2 (commencing with Section 1250) of Division 2 of the Health and Safety Code.
(d) The following notification shall be affixed to all quantities of dimethyl sulfoxide (DMSO) prescribed by a physician, or dispensed by a pharmacy pursuant to the order of a physician in California: "Warning: DMSO may be hazardous to your health. Follow the directions of the physician who prescribed the DMSO for you."
False or Misleading Label on Prescription
Section 4078
No person shall place a false or misleading label on a prescription.
No prescriber shall direct that a prescription be labeled with any information that is false or misleading.
If the labeling is a necessary part of a clinical or investigational drug program approved by the federal Food and Drug Administration or a legitimate investigational drug project involving a drug previously approved by the federal Food and Drug Administration.
If, in the medical judgment of the prescriber, the labeling is appropriate for the proper treatment of the patient.
Division 2, Chapter 9: Business and Professions Code
Article 12: Prescriber Dispensing
Veterinarian in Teaching Hospital May Dispense and Administer Dangerous Drugs and Devices; Requirements
Section 4170.5
(c) The veterinary teaching hospital's pharmacist-in-charge shall develop policies, procedures, and guidelines that recognize the unique relationship between the institution's pharmacists and veterinarians in the control, management, dispensation, and administration of drugs.
Exceptions to Section 4170: Samples; Clinics; Veterinarians; Narcotic Treatment Programs; Certain Cancer Medications
(a) Section 4170 shall not prohibit the furnishing of a limited quantity of samples by a prescriber, if the prescriber dispenses the samples to the patient in the package provided by the manufacturer, no charge is made to the patient therefor, and an appropriate record is entered in the patient's chart.
A prescriber who dispenses drugs pursuant to Section 4170 shall store all drugs to be dispensed in an area that is secure. The Medical Board of California shall, by regulation, define the term "secure" for purposes of this section.
Division 10: Uniform Controlled Substances Act Chapter 5: Use of Controlled Substances
Article 1: Lawful Medical Use Other than Treatment of Addicts
Issuing Prescription: By Whom; For What Purpose; Quantity to Be Prescribed
Section 11210
A physician, surgeon, dentist, veterinarian, naturopathic doctor acting pursuant to Section 3640.7 of the Business and Professions Code, or podiatrist, or pharmacist acting within the scope of a project authorized under Article 1 (commencing with Section 128125) of Chapter 3 of Part 3 of Division 107, or registered nurse acting within the scope of a project authorized under Article 1 (commencing with Section 128125) of Chapter 3 of Part 3 of Division 107, or physician assistant acting within the scope of a project authorized under Article 1 (commencing with Section 128125) of Chapter 3 of Part 3 of Division 107, or naturopathic doctor acting within the scope of Section 3640.5 of the Business and Professions Code, or an optometrist acting within the scope of Section 3041 of the Business and Professions Code may prescribe for, furnish to, or administer controlled substances to his or her patient when the patient is suffering from a disease, ailment, injury, or infirmities attendant upon old age, other than addiction to a controlled substance.
Purchase of Controlled Substances by Hospital Without a Pharmacist for Emergencies; Conditions on Providing to Patients
Obtaining and Using Controlled Substance for Research, Instruction, or Analysis; Conditions
Section 11212
Research Approval by a Research Advisory Panel
Section 11213
New Drugs for Investigational Use in Animals
Part 500, Subpart C: Animal Drug Labeling Requirements
Labeling of animal drugs; misbranding
Section 500.51
Any statement that disclaims liability when the drug is used in accordance with directions for use contained on the label or labeling.
Any statement that disclaims liability when the drug is used under "abnormal" or "unforeseeable" conditions.
Any statement limiting the warranty for the products to a warranty that the drug in the package contains the ingredients listed on the label.
Any person wishing to obtain an evaluation of an animal drug liability disclaimer under this regulation may submit it to Division of Compliance, (HFV-230), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. A supplemental NADA providing appropriately revised labeling shall be submitted for any approved new animal drug the labeling of which is not in compliance with this regulation.
Use of terms such as "tonic", "tone", "toner", or "conditioner" in the labeling of preparations intended for use in or on animals
Section 500.52
(a) The use of terms such astonic, tone, toner, and similar terms in the labeling of a product intended for use in or on animals implies that such product is capable of a therapeutic effect(s) and causes such a product to be a drug within the meaning of section 201(g) of the Federal Food, Drug, and Cosmetic Act. The unqualified use of such terms in a product's labeling fails to provide adequate directions and indications for use of such product and causes it to be misbranded within the meaning of section 502(a) and (f)(1) of the act. The termstonic, tone, toner, and similar terms may be used in labeling only when appropriately qualified so as to fully inform the user regarding the intended use(s) of the product.
(b) The unqualified use of the termconditioner and similar terms in the labeling of a product intended for use in or on animals implies that such product is capable of a therapeutic effect(s) and causes such a product to be a drug within the meaning of section 201(g) of the act. The unqualified use of such terms in a product's labeling fails to provide adequate directions and indications for use of such product and causes it to be misbranded within the meaning of section 502(a) and (f)(1) of the act. The termconditioner and similar terms may be used in labeling only when appropriately qualified so as to fully inform the user regarding the intended use(s) of the product. A product labeled as a "conditioner" or with a similar term can be either a food or drug depending upon the manner in which the term is qualified in the labeling to reflect the product's intended use.
Exemption from certain drug-labeling requirements
Section 500.55
(b) The Commissioner of Food and Drugs has considered submitted material covering a number of drug products and has offered the opinion that the following drugs when intended for those veterinary uses for which they are now generally employed by the veterinary medical profession, should be exempt from the requirements of 201.105(c) of this chapter, provided that they meet the conditions prescribed in this paragraph. Preparations that are not in dosage unit form (for example, solutions) will be regarded as meeting the conditions with respect to the maximum quantity of drug per dosage unit if they are prepared in a manner that enables accurate and ready administration of a quantity of drug not in excess of the stated maximum per dosage unit:
Epinephrine injection. 1:1,000. For cats, dogs, cattle, goats, horses, pigs, and sheep (except as provided in 500.65).
Part 511: New Animal Drugs for Investigational Use
New animal drugs for investigational use exempt from Section 512(a) of the act
Section 511.1b: New animal drugs for clinical investigations in animals
The label shall bear the statements: [Caution. Contains a new animal drug for use only in investigational animals in clinical trials. Not for use in humans. Edible products of investigational animals are not to be used for food unless authorization has been granted by the U.S. Food and Drug Administration or by the U.S. Department of Agriculture. In the case of containers too small or otherwise unable to accommodate a label with sufficient space to bear the caution statements required by paragraph (a) or (b) of this section, the statements may be included on the carton label and other labeling on or within the package from which the new animal drug is to be dispensed.
Prior to shipment of the new animal drug for clinical tests in animals, the sponsor of the investigation shall submit in triplicate to FDA a "Notice of Claimed Investigational Exemption for a New Animal Drug" including a signed statement containing the following information: The identity of the new animal drug.
If the new animal drug is given to food-producing animals, the statement shall contain the following additional information: A commitment that the edible products from such animals shall not be used for food without prior authorization in accordance with the provisions prescribed in this section.
Approximate dates of the beginning and end of the experiment or series of experiments.
The maximum daily dose(s) to be administered to a given species, the size of animal, maximum duration of administration, method(s) of administration, and proposed withdrawal time, if any.
If a sponsor has transferred any obligations for the conduct of any clinical study to a contract research organization, a statement containing the name and address of the contract research organization, identification of the clinical study, and a listing of the obligations transferred. If all obligations governing the conduct of the study have been transferred, a general statement of this transfer--in lieu of a listing of the specific obligations transferred--may be submitted.
Authorization for use of edible products derived from a treated food-producing animal may be granted under the provisions of this section and when the following specified conditions are met, except that in the case of an animal administered any unlicensed experimental veterinary biological product regulated under the viruses, serums, toxins statute (21 U.S.C., chapter V, sec. 151et seq. ) the product shall be exempt from the requirements of this section when U.S. Department of Agriculture approval has been obtained as provided in 9 CFR 103.2. Conditional authorization may be granted in advance of identification of the name(s) and address(es) of the clinical investigator(s) as required by paragraph (b)(4)(iii) of this section. Information required for authorization shall include, in addition to all other requirements of this section, the following: Data to show that consumption of food derived from animals treated at the maximum levels with the minimum withdrawal periods, if any, specified in accordance with paragraph (b)(4)(v)(c ) of this section, will not be inconsistent with the public health; or
Data to show that food derived from animals treated at the maximum levels and with the minimum withdrawal periods, if any, specified in accordance with paragraph (b)(4)(v)(c ) of this section, does not contain drug residues or metabolites.
The name and location of the packing plant where the animals will be processed, except that this requirement may be waived, on request, by the terms of the authorization.[Authorizations granted under this paragraph do not exempt investigational animals and their products from compliance with other applicable inspection requirements. Any person who contests a refusal to grant such authorization shall have an opportunity for a regulatory hearing before FDA pursuant to part 16 of this chapter.]
The sponsor shall assure himself that the new animal drug is shipped only to investigators who: Are qualified by scientific training and/experience to evaluate the safety and/or effectiveness of the new animal drug.
The sponsor: Shall retain all reports received from investigators for 2 years after the termination of the investigation or approval of a new animal drug application and make such reports available to a duly authorized employee of the Department for inspection at all reasonable times.
If the shipment or other delivery of the new animal drug is imported or offered for importation into the United States for clinical investigational use in animals, it shall also meet the following conditions: The importer of all such shipments or deliveries is an agent of the foreign exporter residing in the United States or the ultimate consignee, which person has, prior to such shipments and deliveries, informed FDA of his intention to import the new animal drug as sponsor in compliance with the conditions prescribed in this subdivision; or
The sponsor shall submit either a claim for categorical exclusion under 25.30 or 25.33 of this chapter or an environmental assessment under 25.40 of this chapter.
Program Policy & Procedure Manual (PPM)
Office of New Animal Drug Evaluation Reviewers Chapter: Requirements for Investigational New Animal Drug Exemptions
What is an Investigational New Animal Drug Exemption?
Statutory authority to exempt unapproved investigational new animal drugs from the requirements of an approved new animal drug application (NADA) or abbreviated new animal drug application (ANADA) is in section 512(j) of the Federal Food, Drug, and Cosmetic Act (the act). We often refer to this as an investigational exemption. This exemption makes it possible for unapproved new animal drugs to be shipped in interstate commerce for use by experts, qualified by scientific training and experience, to investigate their safety and effectiveness.
There are two sets of requirements for investigational exemptions. The regulations at 21 CFR part 511 include a set of requirements for exempting unapproved new animal drugs for tests in vitro and in laboratory research animals (21 CFR 511.1(a)) and a different set of requirements for unapproved new animal drugs used in clinical investigations (21 CFR 511.1(b)). These regulations allow sponsors to collect safety and effectiveness data needed to support the approval of new animal drug applications while at the same time protecting the public from unsafe residues of investigational new animal drugs in food.
Exemption Requirements for New Animal Drugs for Clinical Investigation
For new animal drugs used in clinical investigations, the sponsor must establish an investigational new animal drug file ((J)INAD) and meet the requirements for an investigational exemption before shipping the drug in interstate commerce. An original (J)INAD will generally be established for each new chemical entity, species, combination, and dosage form.
The sponsor of a (J)INAD may be an individual or entity who plans to submit an application for approval (i.e., (A)NADA) following the completion of the investigation. The NCIE form submitted to the (J)INAD file must be signed by the sponsor or by an agent acting on behalf of the sponsor. Sometimes a sponsor will ask to establish a (J)INAD file for their investigational new animal drug without including an NCIE form with the submission. The exemption does not apply until an NCIE form is submitted.
In order to exempt a new animal drug for clinical investigational use from sections 512(a) and 512(m) of the act, we must have from the sponsor of the investigation the signed NCIE form in triplicate, or a signed statement containing the following information listed below. Note that we must have this information from the sponsor before each shipment of the new animal drug.
Copies of all labeling and other pertinent information to be supplied to the investigators.
The name and address of each investigator.
The approximate number of animals to be treated and the number of control animals. If this information is not available, the amount of new animal drug to be shipped must be provided.
If the new animal drug is given to food-producing animals, also include: A commitment that edible products from investigational animals will not be used for food without prior authorization from us;
Approximate dates of the beginning and end of the experiment or series of experiments; and
A statement containing the name and address of the contract research organization (CRO) (if any) to which the sponsor has transferred any obligation(s) for the conduct of the clinical investigation, identification of the study or studies involved, and a listing of the obligation(s) transferred.
Furthermore, the requirements below must also be met for an investigational new animal drug to qualify for the exemption:
The label of the new animal drug must bear the statements:
CAUTION: Contains a new animal drug for use only in investigational animals in clinical trials. Not for use in humans. Edible products of investigational animals are not to be used for food unless authorization has been granted by the U.S. Food and Drug Administration or by the U.S. Department of Agriculture.
If it is a bulk substance for use in the manufacture of a new animal drug for investigational use, it must bear the following labeling statement:
CAUTION: For manufacturing, processing, or repacking in preparation of a new animal drug limited by Federal law to investigational use.
If the product container is too small to accommodate a label with sufficient space to bear the caution statements, the statements may be included on the carton label and other labeling on or within the package from which the new animal drug will be dispensed.
The person distributing the new animal drug will use due diligence to assure that it will actually be used for tests in animals and is not used in humans.
The person distributing the new animal drug will maintain adequate records for each shipment of the new animal drug for a period of two years after such shipments and make such records available to us, upon request.
Section 4000 - Labeling
PPM Number 1240
Identification/Promotion of Product Approval
Section 301(l) of the Federal Food, Drug, and Cosmetic Act prohibits the use in labeling or advertising of any human drug or device "any representation or suggestion that approval of an application with respect to such drug or device is in effect." There is no such prohibition regarding animal drugs. The Center for Veterinary Medicine (CVM) is not opposed, in principle, to the appearance of such information on labels or labeling of, or in advertisements for, approved new animal drugs. However, all such additions to labels and package labeling must be submitted to CVM as a special DER to the approved new animal drug application. Promotional labeling for all approved products must be submitted for review at the time of initial dissemination. Prescription animal drug advertising must be submitted at the time of initial publication as currently required by 21 CFR 510.300.
Purpose: This document established CVM policy and provides guidance for reviewing submissions of sponsors interested in voluntarily placing the Food and Drug Administration (FDA) approval information on labels or package labeling or in using it in advertising or other promotional material for approved new animal drugs.
Procedure for Center Recommended Labeling Changes
Purpose: The purpose of this guide is to provide information on labeling changes made through the supplemental approval process.
Antibacterials Labeled for Secondary Infections
In the early 1950s, apparent success in reducing mortality in an unfamiliar turkey disease referred to as mud fever, blue comb, or transmissible enteritis, led researchers to believe that antibiotics and other drugs had a beneficial effect on the causative agent. Several drug products were subsequently approved with claims for prevention and treatment of the disease. Studies on the etiology of the disease extended over a 20-year period. In the early 1970s, the cause of the disease was determined to be a virus which is now generally recognized as a coronavirus.
Because of the above information and the fact that antibacterials are not known generally to affect virus infections, any beneficial effect is believed to result from reducing death loss from secondary bacterial infections caused by bacteria sensitive to the drug. Generally, there is little or no effect on the morbidity of the primary infection. This principle can be applied to all drug products labeled with the indications for use against viral infections or "associated" secondary infections.
Purpose: The purpose of this guide is to provide guidance for review of products intended to control secondary bacterial infections.
The basic purpose of labeling is to enable drugs to be used safely and effectively by lay persons in the case of OTC products, or by veterinarians in the case of prescription items. The user has a right to expect that the same sort of information will be given for all drugs with similar activities. For this reason, uniformity goes beyond the mere physical layout of the labeling. The approved labeling establishes the limits for journal advertising, promotional material, mailing pieces, and verbal representations by the drug firm's detail person. Because of this, a uniform approach to labeling is required.
Purpose: This guide provides criteria to facilitate the consistent and uniform application of policies relating to the review and evaluation of drug labels and labeling.
Although the review of labels for compliance with certain mandatory requirements may appear to be somewhat mechanical, a knowledge of policy, precedent animal drugs, the Act and Regulations, currently accepted good veterinary medical procedures and the application of good judgment are all essential. Consultation with others within the Center/Agency and in other agencies is appropriate and necessary in some situations. (See CVM Guide 1240.2320, "Communication and Liaison with Other Centers and Agencies".)
Purpose: This guide sets forth the general policies to be used in the review and evaluation of labels for animal drug products.
Therapeutic Use Directions for Medicated Feed and Drinking Water
Purpose: This guide establishes the Center's policy on therapeutic use directions for medicated feed and drinking water.
Drugs are often times known by various names which may be code names, chemical names, acronyms, innovator's names, trivial names, official names, compendial names and United States Adopted Names (USAN). Because of the number of drugs available, it is important that we establish a name which is familiar to everyone so we can have a common denominator when discussing a drug. The need for designating a single name for each drug is specified in Section 508 of the Federal Food, Drug, and Cosmetic Act. 21 CFR Part 299 provides regulations that interpret Section 508 of the Act.
Use of an established name, if there is one for a drug, is required by Section 502(e)(1) of the Act as information of the identity of a drug which may be distributed in different dosage forms under different brand or proprietary names by manufacturers or distributors.
Physicians and veterinarians may use or prescribe drugs by an established name instead of a brand name.
Section 4100 - Drugs
Sterility of Ophthalmic Products
In a statement of policy issued on September 1, 1964, the Food and Drug Administration ruled that liquid preparations offered or intended for ophthalmic use that are not sterile may be regarded as adulterated within the meaning of section 501(c) of the FFDCA, and, further, may be deemed misbranded within the meaning of section 502(j) of the Act. On October 28, 1972, this ruling was extended to affect all preparations for ophthalmic use.
Purpose: The purpose of this guide is to clarify the Center's position regarding the sterility of ophthalmic products.
Sterility and Pyrogen Requirements for Injectable Drug Products
Purpose: This guide describes CVM policy regarding sterility and pyrogenicity requirements of veterinary injectable drug products. All injectable veterinary drug products are sterile except euthanasia products and natural and synthetic steroid hormonal ear implants intended for use in bovine and ovine species. Pyrogen levels in sterile, injectable veterinary drug products are within established limits.
Overformulation in Animal
Purpose: This guide establishes the policy and criteria for permitting overformulation of active drug ingredients in animal drug products.
Policy on Sterilization of New Animal Drug Products and Containers by Irradiation
Sterilization by irradiation, in general, is permitted for use with drug products. The administration policy with regard to irradiated drugs is stated in 21 CFR 310.502(a)(11). This regulation addresses only human drug products. However, the policy is also applicable to drugs subject to Section 512 of the Federal Food, Drug, and Cosmetic Act (FFDCA) which includes drugs for animal use. There are no other specific regulatory requirements at this time for using this procedure.
Part 530: Extralabel Drug Use in Animals
Subpart A, Section 530.05
Subpart B, Section 530.11
Extralabel use resulting in any residue above an established safe level, safe concentration or tolerance.
Subpart B, Section 530.12
The name and address of the prescribing veterinarian. If the drug is dispensed by a pharmacy on the order of a veterinarian, the labeling shall include the name of the prescribing veterinarian and the name and address of the dispensing pharmacy, and may include the address of the prescribing veterinarian;
The established name of the drug or, if formulated from more than one active ingredient, the established name of each ingredient;
Any directions for use specified by the veterinarian, including the class/species or identification of the animal or herd, flock, pen, lot, or other group of animals being treated, in which the drug is intended to be used; the dosage, frequency, and route of administration; and the duration of therapy
Any cautionary statements; and
The veterinarian's specified withdrawal, withholding, or discard time for meat, milk, eggs, or any other food which might be derived from the treated animal or animals.
Extralabel use from compounding of approved new animal and approved human drugs
Subpart B, Section 530.13
This part applies to compounding of a product from approved animal or human drugs by a veterinarian or a pharmacist on the order of a veterinarian within the practice of veterinary medicine. Nothing in this part shall be construed as permitting compounding from bulk drugs.
Extralabel use from compounding of approved new animal or human drugs is permitted if: All relevant portions of this part have been complied with;
There is no approved new animal or approved new human drug that, when used as labeled or in conformity with criteria established in this part, will, in the available dosage form and concentration, appropriately treat the condition diagnosed. Compounding from a human drug for use in food-producing animals will not be permitted if an approved animal drug can be used for the compounding;
The compounding is performed by a licensed pharmacist or veterinarian within the scope of a professional practice;
Guidance on the subject of compounding may be found in guidance documents issued by FDA.
Extralabel drug use in nonfood animals
Subpart D, Section 530.30
Drugs prohibited for extra label use in animals
Subpart E, Section 530.41
The following drugs, families of drugs, and substances are prohibited for extralabel animal and human drug uses in food-producing animals Chloramphenicol;
Fluoroquinolones; and
Cephalosporins (not including cephapirin) in cattle, swine, chickens, or turkeys: For disease prevention purposes;
At unapproved doses, frequencies, durations, or routes of administration; or
If the drug is not approved for that species and production class.
The following drugs, families of drugs, and substances are prohibited for extralabel animal and human drug uses in nonfood-producing animals: [Reserved]
The following drugs, or classes of drugs, that are approved for treating or preventing influenza A, are prohibited from extralabel use in chickens, turkeys, and ducks: Adamantanes
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