FDA's Statement on Compounding of Animal Drugs last updated 1/18/2012

Compounding of Animal Drugs

In general, compounding an animal drug from an active pharmaceutical ingredient (bulk drug) is not permitted by the Act unless covered by an approved new animal drug application. This is true even if the compounder is a veterinarian or a pharmacist. However, CVM acknowledges the medical need for compounding may exist within certain areas of veterinary practice. The contemporary practice of veterinary medicine requires products to treat hundreds of conditions and diseases in dozens of species. Consequently, veterinarians continue to require products to treat diseases or conditions in animals for which no FDA-approved product is available. Generally, FDA will defer to state authorities regarding the day-to-day regulation of compounding by veterinarians and pharmacists of animal drugs. In limited circumstances, the agency may not object to compounding from specific bulk drugs under specific conditions. However, FDA will consider enforcement action when the activities of veterinarians and pharmacists are clearly outside the bounds of traditional pharmacy practice and are instead more akin to those of a drug manufacturer. Additional information on the FDA policy regarding animal drug compounding can be found in Compliance Policy Guide, Section 608.400, “Compounding of Drugs for Use in Animals⁵."

Animal drugs may be legally compounded from FDA-approved animal drugs and FDA-approved human drugs if the compounding practices are in conformance with the provisions of the regulation on the Extra-label Use of FDA-approved drugs⁶.

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source located here; Page Last Updated: 01/18/2012 

Repost: Use Caution When Buying Pet Medications Online

Gigi Davidson, Director of Clinical Pharmacy Services with North Carolina State University’s Veterinary Teaching Hospital, has warned owners about buying pet medications online. She was previously interviewed as part of an extensive report by WBTV in Charlotte, NC. To view the report, click here.  For more information click here.

MAINE VETERINARY PRACTICE ACT Regarding Prescriptions

Title 32: PROFESSIONS AND OCCUPATIONS   Chapter 71-A: MAINE VETERINARY PRACTICE ACT OF 1975 HEADING: PL 1997, C. 246, §1 (RPR) §4876. Prescriptions of other veterinarians.  A licensed veterinarian may sell and dispense the written prescription of another licensed veterinarian with respect to any prescription or administration of a drug, medicine or nutritional substance on, for or to any animal in accordance with this chapter. [2011, c. 30, §1 (NEW).] SECTION HISTORY 2011, c. 30, §1 (NEW). 

Louisiana Board of Veterinary Medicine Rules and Regulations Relating to Prescriptions

Louisiana's Principles of Veterinary Medical Ethics of the American Veterinary Medical Association (AVMA)

III.     THE VETERINARIAN - CLIENT – PATIENT RELATIONSHIP

A.     The veterinarian - client - patient relationship (VCPR) is the basis for interaction among veterinarians, their clients, and their patients.  A VCPR exists when all of the following conditions have been met:

(1)   The veterinarian has assumed responsibility for making clinical judgments regarding the health of the animal(s) and the need for medical treatment, and the client has agreed to follow the veterinarian’s instructions.

(2)   The veterinarian has sufficient knowledge of the animal(s) to initiate at least a general or preliminary diagnosis of the medical condition of the animal(s).  This means that the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal(s) by virtue of an examination of the animal(s), or by medically appropriate and timely visits to the premises where the animal(s) are kept.

Kansas Veterinary Rules Regarding Prescriptions

KANSAS ADMINISTRATIVE REGULATIONS
PUBLISHED APRIL 1997
Kansas Board Veterinary Examiners
Amendment/Addendum to the Kansas Administration Regulations

Article 7.--STANDARDS OF VETERINARY PRACTICE
70-7-1 The practice of veterinary medicine. Each veterinarian shall meet the following minimum standards in the practice of veterinary medicine.

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(j) Controlled drugs. The veterinarian shall ensure that a separate written ledger is maintained when a controlled
drug is administered or dispensed.
(k) Locked area. If controlled drugs are used, the veterinarian shall ensure that a locked area for the storage
of controlled substances is provided.
(l) Dispensation of medications for companion animals.
(1) All prescription drugs to be dispensed for use by a companion animal may be dispensed only on the order of a licensed veterinarian who has an existing veterinary client-patient relationship as defined by the Kansas veterinary practice act. The veterinarian shall ensure that labels will be affixed to any unlabeled container containing any medication dispensed and to each factory-labeled container that contains prescription drugs or controlled substances dispensed for companion animals. The label shall be affixed to the immediate container and shall include the following information:
(A) The name and address of the veterinarian and, if the drug is a controlled substance, the veterinarian’s telephone number;
(B) the date of delivery or dispensing;
(C) the name of the patient, the client’s name, and, if the drug is a controlled substance, the client’s address;
(D) the species of the animal;
(E) the name, active ingredient, strength, and quantity of the drug dispensed;(F) directions for use specified by the practitioner including dosage, frequency, route of administration, and duration of therapy; and
(G) any cautionary statements required by law, including statements indicating that the drug is not for human consumption, is poisonous, or has withdrawal periods associated with the drug. If the size of the immediate container is insufficient to be labeled, the container shall be enclosed within another container large enough to be labeled.
(2) The term ‘‘companion animal’’ shall have the meaning specified in K.S.A. 47-816 and amendments thereto.
(m) Dispensation of medications for food or commercial animals. All prescription drugs to be dispensed for
food used by a food animal or used by a commercial animal may be dispensed only on a written order of a licensed veterinarian with an existing veterinary-client-patient relationship as defined by the Kansas veterinary practice act. That veterinarian shall maintain the original written order on file in the veterinarian’s office. A copy of the written order shall be on file with the distributor, and a second copy shall be maintained on the premises of the patient-client. The written order shall include the following information:
(1) The name and address of the veterinarian and, if the drug is a controlled substance, the veterinarian’s telephone number;

Kentucky Board of Veterinary Examiners Rules and Regulations Relating to Prescribing and dispensing Drugs

KENTUCKY ADMINISTRATIVE REGULATIONS
201 KAR 16:010. Code of ethical conduct.

Section 7. (1) A veterinarian shall not sell, or offer for sale, prescription medicine or drugs at any place other than:
(a) His office, clinic, or hospital; or
(b) Other place where he is treating patients.
(2) The prescription drugs or medicines sold, or offered for sale, shall be used in the treatment of the patient the veterinarian is treating.
(3) A veterinarian may fill the prescription of another licensed veterinarian who has established a bona fide veterinarian-client-patient relationship in a case.


201 KAR 16:110. Prescription and dispensation of drugs for animal use.
RELATES TO: KRS 321.181(5)(b)
STATUTORY AUTHORITY: KRS 321.235(3), 321.240(5)
NECESSITY, FUNCTION, AND CONFORMITY: KRS 321.181(5)(b) provides that the practice of veterinary medicine includes the prescribing, administering, or dispensing of drugs and medications for veterinary purposes. KRS 321.235(3) and 321.240(5) authorize the board to promulgate administrative regulations to carry out and enforce the provisions of KRS Chapter 321. This administrative regulation establishes a procedure for the prescription and dispensation of drugs by licensed veterinarians for use in animals and livestock.
Section 1. Definitions. (1) "Legend drug" means veterinary prescription drug.(2) "Prescription" means an order from a veterinarian to a pharmacist or another veterinarian authorizing the dispensing of a veterinary prescription drug to a client for use on or in a patient;
(3) "Veterinary drug" means:
(a) A drug for animal use recognized in the official United States Pharmacopoeia or National Formulary of the United States;
(b) A drug intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals;
(c) A drug, other than feed, medicated feed, or a growth promoting implant intended to affect the structure or function of the body of an animal; or
(d) A drug intended for use as a component of a drug in paragraph (a), (b), or (c).
(4) "Veterinary prescription drug" means:
(a) A drug that is not safe for animal use without a veterinarian using or ordering the use of the product, and that is required by federal law to bear the following statement: "Caution: federal law restricts this drug to use by or on the order of a licensed veterinarian";
(b) A drug that is required by state law to be dispensed only on order or prescription of a licensed veterinarian;
(c) The extra-label use of an over-the-counter animal drug or human drugs; and
(d) A medicament compounded by mixing two (2) or more legally-obtained over-the-counter or prescription drugs.
Section 2. Prescribing and Dispensing. (1) A veterinary prescription shall include all of the following:
(a) The name and address of the veterinarian and, if the prescription is a written order, the signature of the veterinarian;
(b) The name and address of the client;
(c) The species and identity of the patient for which the prescription is issued;
(d) The name, strength, and quantity of the drug prescribed;
(e) The date on which the prescription is issued;
(f) The directions for administering the drug;
(g) If the patient is a food producing animal, the withdrawal time for the veterinary drug;
(h) If the prescription authorizes extra-label use, the manner in which the client may use the drug;
(i) Any cautionary statements required by law; and
(j) Number of refills allowed.
(2) A veterinarian shall not:
(a) Prescribe for or dispense to a client a veterinary prescription drug or a drug for extra-label use without personally examining the patient unless a veterinary-client-patient relationship exists between the prescribing veterinarian, client and patient, and the veterinarian determines that the client has sufficient knowledge to administer the drug properly;
(b) Prescribe or dispense a veterinary prescription drug to a client unless the veterinarian indicates in the appropriate records described in Section 4 of this administrative regulation, within seventy-two (72) hours after the prescription is issued or the drug is dispensed, that the prescription has been issued or that the drug has been dispensed;
(c) Prescribe a drug to a client for extra-label use on a patient unless all of the following apply:
1. A veterinary-client-patient relationship exists between the veterinarian, client and patient and the veterinarian has made a careful medical diagnosis of the condition of the patient within the context of that veterinarian-client-patient relationship;2. The veterinarian determines that there is no drug that is marketed specifically to treat the patient’s diagnosed condition, or determines that all of the drugs that are marketed for that purpose are clinically ineffective;
3. The veterinarian recommends procedures for the client to follow to ensure that the identity of the patient shall be maintained; and
4. If the patient is a food producing animal, the veterinarian prescribes a sufficient time period for drug withdrawal before the food from the patient may be marketed; or
(d) Transmit a prescription electronically unless the client approves the transmission and the prescription is transmitted to a pharmacist or veterinarian designated by the client.
Section 3. Labeling. (1) A veterinarian shall not dispense a drug that has been prepared, mixed, formulated or packaged by the veterinarian unless the veterinarian affixes to the container in which the drug is dispensed a label containing all of the information specified in Section 2(1) of this administrative regulation, except the address of the client.
(2) A veterinarian shall not dispense a veterinary prescription drug that has been prepackaged by its manufacturer for dispensing unless the veterinarian affixes to the container in which the drug is dispensed a label containing all of the information specified in Section 2(1) of this administrative regulation, except the address of the client.
(3) A veterinarian may dispense a veterinary over the counter drug without affixing any information to the container in which the drug is dispensed if a label that has been affixed to the container by its manufacturer provides adequate information for its use.
Section 4. Prescription Records. (1) A veterinarian shall maintain complete records of each veterinary prescription drug that the veterinarian receives, prescribes, dispenses or administers, and of each prescription issued by the veterinarian that authorizes extra-label use.
(2) Records of each veterinary prescription drug shall include the name of each veterinary prescription drug that is received, the name and address of the person from whom the drug is received and the date and quantity received, the name and address of the person to whom the drug is dispensed and the date and quantity dispensed and, if the veterinarian prescribes or administers the drug, the information specified in Section 2(1) of this administrative regulation.
(3) Records of each prescription authorizing extra-label use shall include the information specified in Section 2(1) of this administrative regulation.
(4) A veterinarian shall maintain records of each veterinary prescription drug for not less than five (5) years after the date on which the veterinarian prescribes, dispenses or administers the drug or extra-label use.
Section 5. (1) A veterinarian shall not be required to write a prescription for controlled substances or a prescription for any medication that, in the veterinarian’s medical judgment, is not appropriate for the patient’s medical care.
(2) A veterinarian may refuse to write a prescription if it is not directly requested by a client with whom there is, in the veterinarian’s opinion, a current and existing veterinarian-patient-client relationship.
(3) A prescription shall be construed to include any manner of authorization for filling a prescription, including verbal or electronic communication.(4) The veterinarian may delegate to an office employee the authority to communicate a refill of a legend drug to the pharmacy on behalf of the veterinarian pursuant to written protocol established prior to the delegation of that authority.
Section 6. (1) A veterinarian shall ensure that all federal legend drugs and veterinary prescription drugs are maintained, administered, prescribed, dispensed, and destroyed in compliance with all state and federal laws.
(2) A veterinarian shall not prescribe or dispense a quantity of drug that is greater than that the amount required for six (6) months of treatment for an animal, herd, or flock.
(3) To prescribe, sell, distribute, or dispense any drug requiring a prescription for use in the context of an animal, herd, or flock, a veterinarian shall first do all of the following:
(a) Perform an appropriate history and physical examination;
(b) Make a diagnosis based upon the history, physical examination, and pertinent diagnostic and laboratory tests;
(c) Formulate a therapeutic plan, and discussed it with the animal’s owner, agent, or guardian, along with the basis for it and the risks and benefits of various treatments options, a part of which might be a prescription drug; and
(d) Ensure availability of the veterinarian or the veterinarian’s staff for appropriate follow-up care.
Section 7. (1) A veterinarian may dispense a prescription drug only if the prescribing veterinarian has established a veterinarian-client-patient relationship.
(2) If the dispensing veterinarian does not have a veterinarian-client-patient relationship, a veterinary assistant may assist in the delivery of a veterinary drug, legend drug, or veterinary prescription drug only under the direct supervision of the licensed veterinarian by who the assistant is employed.
(3) If the dispensing veterinarian does have a veterinarian-client-patient relationship, a veterinary assistant may assist in the delivery of a veterinary drug, legend drug, or veterinary prescription drug under the indirect supervision of the veterinarian by whom the assistant is employed.
(4) If a veterinary assistant acts under the provisions of this section, it shall be the responsibility of the licensed veterinarian to ensure that the requirements of this administrative regulation are met.

Complete act can be viewed here.

Use Caution When Buying Pet Medications Online

Gigi Davidson, Director of Clinical Pharmacy Services with North Carolina State University’s Veterinary Teaching Hospital, has warned owners about buying pet medications online. She was previously interviewed as part of an extensive report by WBTV in Charlotte, NC. To view the report, click here.  For more information click here.

Illinois Veterinary Medicine and Surgery Practice Act of 1994 Relating to Dispensing Drugs and the Illinois Rules

(225 ILCS 115/25) (from Ch. 111, par. 7025)
(Section scheduled to be repealed on January 1, 2014)
Sec. 25. Disciplinary actions.
1. The Department may refuse to issue or renew, or may revoke, suspend, place on probation, reprimand, or take other disciplinary action as the Department may deem appropriate, including fines not to exceed $1,000 for each violation, with regard to any license or certificate for any one or combination of the following: 

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(13.5) Any pharmacist licensed in the State,

merchant, or manufacturer selling at his or her regular place of business medicines, feed, appliances, or other products used in the prevention or treatment of animal diseases as permitted by law and provided that the services he or she provides do not include diagnosing, prognosing, writing prescriptions, or surgery. *** FF. Using, prescribing, or selling a prescription drug or the extra-label use of a prescription drug by any means in the absence of a valid veterinarian-client-patient relationship. CHAPTER VII: DEPARTMENT OF FINANCIAL AND PROFESSIONAL REGULATION SUBCHAPTER b: PROFESSIONS AND OCCUPATIONS PART 1500 VETERINARY MEDICINE AND SURGERY PRACTICE ACT OF 2004 SECTION 1500.50 STANDARDS OF PROFESSIONAL CONDUCT Section 1500.50 Standards of Professional Conduct a) In determining what constitutes dishonorable, unethical or unprofessional conduct of a character likely to deceive, defraud or harm the public, the Board or hearing officer shall consider the following standards as they relate to the person who is the subject of the proposed disciplinary action. The standards shall include, but not be limited to:  ***      2) Wilfully violating or knowingly assisting in the violation of any law relating to the use or dispensing of any medicine or drug as specified in Section 17 of the Act; 3) Wilfully administering or prescribing illegal drugs for animals; 4) Wilfully administering or prescribing prescription drugs illegally. Illegally means: A) In violation of the rules governing a competition or exhibition of animals, including but not limited to the rules of the Illinois Racing Board (11 Ill. Adm. Code 509), the American Kennel Club and the American Show Horse Association;  *** 11) Failing to maintain adequate medical records, including but not limited to the following: *** F) All medical treatment must include identification of each medication given in the practice, together with the date, dosage, and route of administration and frequency and duration of treatment; G) All medicines dispensed or prescribed must be recorded, including directions for use and quantity; H) Any changes in medications or dosages, including telephonically or electronically initiated changes, must be recorded; Statutes and Rules can be found here

Idaho Statutes and Administrative Code Relating to Veterinary Medicine/Prescription Rules

The statutes in Idaho relating to discipline of veterinarians provide:

TITLE 54

PROFESSIONS, VOCATIONS, AND BUSINESSES

CHAPTER 21

VETERINARIANS

 54-2115. GROUNDS FOR DISCIPLINE. The board may refuse to issue, renew or reinstate the license of a veterinarian, or may deny, revoke, suspend, sanction, reprimand, restrict, limit, place on probation or require voluntary surrender of, the license of a veterinarian, and may fine and impose other forms of discipline and enter into consent agreements and negotiated settlements with any licensed veterinarian pursuant to the procedures set forth in chapter 52, title 67, Idaho Code, for any or all of the following reasons:

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(15) The use, prescription or sale of any controlled substance, veterinary legend/prescription drug or prescription of an extra-label use for any human or veterinary drug without a valid veterinarian/client/patient relationship.

Idaho Statute found here.

The IDAHO ADMINISTRATIVE CODE IDAPA 46.01.01, Board of Veterinary Medicine Rules of the State Board of Veterinary Medicine that relates to prescriptions and controlled substances provides:

152. CODE OF PROFESSIONAL CONDUCT.

The Board’s code of professional conduct includes, but is not limited to, the following standards of conduct: (7-1-97)

01. Veterinarian/Client/Patient Relationship. A veterinarian shall not dispense or prescribe 

controlled substances, prescription or legend drugs except in the course of his professional practice and after a bona 

fide veterinarian/client/patient relationship as defined by Section 150 of these rules has been established. (3-30-01)

01. Medical Records. Medical records shall include, but not be limited to: (7-1-97)

Georgia Statutes Relating to Prescription Drugs in Veterinary Practice

TITLE 43. PROFESSIONS AND BUSINESSES CHAPTER 50. VETERINARIANS AND VETERINARY TECHNICIANS ARTICLE 1. GENERAL PROVISIONS
43-50-1. Short title.
This chapter shall be known and may be cited as the 'Georgia Veterinary Practice Act.'
HISTORY: Code 1933, § 84-1501, enacted by Ga. L. 1965, p. 92, § 1; Ga. L. 1999, p. 81, § 43; Ga. L. 2003, p. 615, § 1-1.

(1 ) 'Prescription drug' includes any medicine medication or pharmaceutical or biological product whose manufacturers' label must, pursuant to federal or state law, have the following statement printed on its packaging: 'Federal law restricts this drug to use by or on the order of a licensed veterinarian'; or any over-the-counter product that is used in a manner different from the label directions and that by definition requires a valid veterinarian-client-patient relationship for prescription or dispensing.

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(15) 'Veterinarian-client-patient relationship' means that:
(A) The licensed veterinarian or his or her licensed designee has assumed the responsibility for making medical judgments regarding the health of the animal and the need for medical treatment, and the client (owner or caretaker) has agreed to follow the instruction of the licensed veterinarian;
(B) There is sufficient knowledge of the animal by the licensed veterinarian to initiate at least a general or preliminary diagnosis of the medical condition of the animal. This means that the licensed veterinarian has recently seen and is personally acquainted with the keeping and care of the animal by the virtue of examination of the animal or by medically appropriate and timely visits to the premises where the animal is kept; and
(C) A licensed veterinarian is readily available for follow up in the case of adverse reactions or failure of the regimen of therapy.



43-50-41. Disciplinary action; subpoenas; judicial review; reinstatement; investigatory powers; immunity; failure to appear; voluntary surrender of license or registration.
(a) The board is authorized to refuse to grant a license or registration to an applicant, to revoke the license or registration of a person licensed or registered by the board, or to discipline a person licensed or registered under this chapter or any antecedent law, upon a finding by a majority of the entire board that the licensee, registrant, or applicant has:

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(12) Engaged in the excessive prescribing or administering of drugs or treatment or the use of diagnostic procedures which are detrimental to the patient as determined by the customary practice and standards of the local community of licensees; or knowingly prescribed controlled drug substances or any other medication without a legitimate veterinary medical purpose; or knowingly overprescribed controlled drug substances or other medication, in light of the condition of the patient at the time of prescription;

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(14) Used, prescribed, or sold any veterinary prescription drug or prescribed an extralabel use of any drug in the absence of a valid veterinarian-client-patient relationship; or
(15) Has had his or her U.S. Drug Enforcement Administration privileges restricted or revoked.

43-50-44. Exemptions.
This article shall not be construed to prohibit:

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(6) Any merchant or manufacturer selling, at his or her regular place of business, medicines, feed, appliances, or other products used in the prevention or treatment of animal diseases. This shall not be construed to authorize the sale of medicines which must be obtained by a prescription from a pharmacist but shall only include the right to sell those medicines which are classified as proprietary and which are commonly known as over-the-counter medicines;

Complete statute found here

DISTRICT OF COLUMBIA MUNICIPAL REGULATIONS for VETERINARIANS

DISTRICT OF COLUMBIA MUNICIPAL REGULATIONS for VETERINARIANS relating to dispensing drugs provide:


2813. MANAGEMENT AND USE OF DRUGS
2813.1 A veterinarian shall prescribe, administer, or dispense drugs only for use on animals within the course of the veterinarian's professional practice. A veterinarian shall not prescribe drugs for use by humans.
2813.2 A veterinarian shall prescribe drugs only by a written prescription or on oral prescription to a pharmacist as authorized by, and in compliance with, applicable with, applicable District and federal laws and regulations.
2813.3 A written prescription shall have the following:
(a) Be signed by the prescribing veterinarian;
(b) Be dated on the day issued;
(c) Contain the full name and street address of the owner of the animal, the species of animal for which the drug is prescribed; and
(d) Contain the full name and street address of the veterinarian and the veterinarians's Drug Enforcement Administration number.
2813.4 Drugs may be administered only by a veterinarian or a veterinary assistant properly trained by a veterinarian in the manner of such administration of drugs and under the immediate direction of a veterinarian.
2813.5 A veterinarian shall retain the records required by this section for three (3) years and shall keep them separate from other records.
2813.6 The director may exempt holders of a special permit issued pursuant to § 2816 from the requirement of having a veterinarian administer or supervise the use of sodium pentobarbital.
2813.7 All drugs shall be dispensed by a veterinarian, or by a veterinary assistant pursuant to a prescription of a veterinarian. A veterinarian shall thoroughly inspect the prepared prescription and verify its accuracy in all respects.
2813.8 All drugs dispensed by a veterinarian shall be labeled with the following information:
(a) The name, address, and telephone number of the animal facility;
(b) The name and strength of the drug;
(c) The name of the client and animal identification;

(d) The date dispensed;
(e) Directions for use;
(f) The expiration date of the drug, where applicable; and
(g) The name of the prescribing veterinarian.
2813.9 All drugs dispensed by a veterinarian shall be in air-tight and light-resistant containers. All drugs dispensed by any veterinarian shall he in approved safety closure containers, unless the owner of the animal expressly requests that the medication not be provided in such containers.
2813.10 A veterinarian shall keep an account of all drugs prescribed, administered, or dispensed in the client record.
2813.11 A veterinarian shall keep controlled substances records separate from the client's other records and shall maintain them in chronological order for the administration, dispensing, or application of all Schedule II, III, IV and V drugs listed as part of the District of Columbia Uniform Controlled suhstances Act of 1981, D.C. Law 4-29, D.C. Code §§ 33-501 to 33-567. This record shall include the following:
(a) The date of transaction;
(b) The name of the drug and the amount dispensed or administered;
(c) The name of the client and animal identification; and
(d) The name of person administering, dispensing, or selling the drug.
2813.12 A veterinarian shall maintain invoices for all Schedule II, III, IV, and V drugs received on the premises where the stock of drugs is held, and shall keep invoices for schedule II drugs separate from other records. All records shall be maintained for a period of three (3) years from the date of a transaction.
2814. STORAGE AND INVENTORY OF DRUGS
2814.1 Drugs shall be stored in the following manner:
(a) Under conditions specified on the label of the original container, or as specified in the official veterinary medicine compendium;
(b) In accordance with applicable District and federal laws and regulations; and
(c) Under secure conditions so as to prevent theft or diversion.
2814.2 Drug storage areas shall he secure and temperature controlled and shall be kept clean and orderly.
2814.3 The stock of drugs and biologicals shall he reviewed at reasonable intervals so that working stock, at the time of expiration, are removed.
2814.4 A veterinarian shall take an inventory of all Schedule II, III, IV, and V drugs under the veterinarian's control every two (2) years and shall date and sign the inventory. The inventory shall indicate if it was made at the opening or closing of business and shall be kept on the premises where the drugs are stocked for three (3) years from the date of the inventory.
2814.5 A veterinarian shall keep Schedule II controlled substances in a locked area. Only a veterinarian shall have access to such drugs.
2814.6 A veterinarian shall immediately report the theft or unusual loss of Schedule II, III, IV or V controlled substances to the Department and the United States Drug Enforcement Administration. The Director shall make such forms available without charge to all veterinarians.

DISTRICT OF COLUMBIA MUNICIPAL REGULATIONS for VETERINARIANS is located here.

Delaware Laws Regarding the Practice of Veterinary Medicine

The statutes in Delaware provide as follow with regard to the practice of veterinary medicine:

Title 24 Professional Regulation of the Delaware Statutes

2.0 Unprofessional Conduct for Veterinarians (24 Del.C. §3313(a)(1))

2.1 Unprofessional conduct in the practice of veterinary medicine shall include, but not be limited to, the following;

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2.1.11 Improper labeling of prescription drugs. The package or label must contain the following information, either typed or in legible handwriting:

2.1.11.1 Name and address of the prescribing veterinarian;

2.1.11.2 Patient's first name and owner's last name;

2.1.11.3 Name, strength and quantity of the drug, and date dispensed;

2.1.11.4 Specific usage directions, describing the exact method by which the drug must be administered. A prescription without specific directions, or a prescription bearing the notation "as directed" without specific directions, may not be prepared or dispensed.

2.1.12 Failure to make childproof packaging available for prescription drugs upon the request of a client.

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2.1.15 Prescribing medication without examining the animal(s) within a period of one year.

Arkansas Veterinary Medical Examining Board Practice Act Relating to Prescription Drugs

ARKANSAS VETERINARY MEDICAL EXAMINING BOARD PRACTICE ACT
§17-101-305(a)(14) deals with the discipline of veterinarians in Arkansas who use, prescribe or sale veterinary prescription drugs without a valid veterinarian-client-patient relationship. That section provides as follows:


 VETERINARIANS - DENIAL, SUSPENSION OR REVOCATION OF LICENSE
(a) Upon written complaint by any person or on the Board‟s own motion and after notice and hearing as prescribed in the Administrative Procedure Act (25-15-201 et. Seq.), the Board may deny, suspend for a definite period or revoke the license of any veterinarian and/or impose a civil penalty for:

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(14) The use, prescription or sale of any veterinary prescription drug, or the prescription of an extra-label use of any over-the-counter drug in the absence of a valid veterinarian-client-patient relationship;


The Practice Act is found here.

Arizona's Veterinary Administrative Rules Regarding Drug Dispensing

Arizona's Veterinary Administrative Rules, which should be read in conjunction with the statutes discussed in the previous blog, relating to drug dispensing have a requiring that the veterinarian notify the animal owner that some prescription-only drugs and controlled substances may be available at a pharmacy.

ARTICLE 8. DRUG DISPENSING
R3-11-801. Notification that Prescription-only Drugs or Controlled Substances May Be
Available at a Pharmacy
A.  A dispensing veterinarian shall notify an animal owner that some prescription-only drugs and 
     controlled substances may be available at a pharmacy by:
     1.  Stating the availability at or before the time of dispensing;
     2.  Posting a written statement that is visible to the animal owner; or
     3.  Providing the animal owner with written notification.
B.   A dispensing veterinarian may provide a written prescription to the animal owner if requested by
an animal owner.
R3-11-802. Labeling Requirements
A veterinarian shall dispense a prescription-only drug or a controlled substance in a container
bearing a legible label that sets forth all of the information in A.R.S. § 32-2281(A)(1), and the name
and telephone number of the veterinary medical premises from which the prescription-only drug or
controlled substance is dispensed.
R3-11-803. Packaging Requirements
A.   A veterinarian shall dispense four ounces or less of a prescription-only drug in a childproof
container unless the animal owner waives this requirement.
B.   A veterinarian shall dispense a controlled substance in a childproof container.  
C.   A veterinarian may dispense more than four ounces of a bulk prescription-only drug in a nonchildproof container.
D.   A veterinarian may dispense a prescription-only drug in the manufacturer's original dispensing
package without repackaging the prescription-only drug in a childproof container.
R3-11-804. Reserved 28
R3-11-805. Storage
A.   A dispensing veterinarian shall store controlled substances under lock and key except for
controlled substances that are authorized by a responsible veterinarian to be administered by
personnel.
B.   A dispensing veterinarian shall store prescription-only drugs in an area to which members of the
public are not allowed access unless accompanied by a veterinarian or a member of the
veterinarian's staff.
C.   A dispensing veterinarian shall store prescription-only drugs and prescription-only devices in
compliance with state and federal laws and in compliance with the manufacturer's requirements.
R3-11-806. Reserved
R3-11-807. Dispensing a Controlled Substance or Prescription-only Drug
A.   When dispensing a controlled substance:
1.  A dispensing veterinarian or personnel who are not veterinarians but who
     are authorized by a veterinarian may:
           a. Select the controlled substance,
           b. Count the quantity of the controlled substance, and       
           c. Place the controlled substance in a prescription container.
         2.  Licensed or unlicensed personnel may:
           a. Prepare labels,
           b. Prepare drug containers for controlled substances, or          
            c. Record information required by state and federal laws.
3.   A dispensing veterinarian shall review the label of a repackaged controlled substance and
the patient's medical record and ensure that the label complies with R3-11-502 and state and
federal laws before the controlled substance is dispensed.
B.   When dispensing a prescription-only drug:
1.   A dispensing veterinarian or personnel who are not veterinarians but who are                          
authorized by a veterinarian may:
            a. Repackage prescription-only drugs,     
            b. Prepare labels,            
            c. Prepare containers for prescription-only drugs, or   
            d. Record information required by state or federal laws.
      2.  The dispensing veterinarian authorizing the dispensing shall ensure that records are 
maintained according to R3-11-502(K) and R3-11-502(L) and all state and federal laws are
followed.

These statutes can be found here.

Arizona's Veterinary Medical Examining Board Statute Regarding Dispensing of Drugs and Devices

Arizona's veterinary statute regarding dispensing of drugs and devices provides:

Article 7  Dispensing of drugs and devices
32-2281. Dispensing of drugs and devices; conditions; definition
A. A veterinarian may dispense drugs and devices kept by the veterinarian if:
 1. All prescription-only drugs are dispensed in packages labeled with the following
information:
  (a) The dispensing veterinarian's name, address and telephone number.
  (b) The date the drug is dispensed.
  (c) The animal owner's name and the animal's or herd's identification.
  (d) The name, strength and quantity of the drug, directions for its use and any
        cautionary statements.
  2. The dispensing veterinarian enters into the medical record the name, strength and
quantity of the drug dispensed, the date the drug is dispensed and the therapeutic
reason.
B. The Board shall adopt rules providing that the animal's owner or the person responsible
for the animal shall be notified that some prescription-only drugs may be available at a
pharmacy and a written prescription may be provided to the animal's owner or the person
responsible for the animal if requested.
C. A veterinarian shall dispense only to the animal's owner or person responsible for the
animal he is treating and only for conditions being treated by that veterinarian.  The
veterinarian shall supervise the dispensing process.  In this subsection, "supervision" means
that a veterinarian makes the determination as to the legitimacy or the advisability of the drugs
or devices to be dispensed.
D. This section shall be enforced by the Board which shall establish rules regarding access
to, labeling, record keeping, storage and packaging of drugs that are consistent with the
requirements of chapter 18 of this title.  The Board may conduct periodic inspections of
dispensing practices to assure compliance with this section and applicable rules.
E. For the purposes of this section, "dispense" means the delivery by a veterinarian of a
prescription-only drug or device to an animal, an animal's owner or the person responsible for
an animal and includes the prescribing, administering, packaging, labeling and security
necessary to prepare and safeguard the drug or device for delivery.

The statute can be found here.

Alaska's VeterinaryMedical Examining Board Statute Regarding Prescription Labeling

Alaska's veterinary statute provides the following with regard to labeling:

12 AAC 68.900. PRESCRIPTION LABELING. (a) All drugs prescribed and dispensed by a veterinarian for patient treatment must be labeled at the time of dispensing.
(b) The prescription label, or unit dosage package, must contain
(1) name of the owner of the patient;
(2) name of the prescribing veterinarian;
(3) name of the drug;
(4) strength and quantity of the drug;
(5) date dispensed;
(6) name and address of the veterinary facility dispensing the drug; and
(7) directions for the owner administering the drug to the patient.

The FDA's Position on Dispensing Veterinary Prescription Drugs and Labeling and Script Requirements

Dispensing Veterinary Prescription Drugs

Since adequate directions for safe and effective lay use cannot be written for animal prescription drug products, such products can only be sold on the prescription or other order of a licensed veterinarian (Section 503(f)). Prior to being sold or dispensed, they must remain in the possession of a person or firm regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of animal prescription drug products. The drug products may be distributed only by persons or firms authorized by State and local laws.

Sale (dispensing, shipping, or otherwise making available for use in animals) of an animal prescription drug product to the layperson may be made only by or on the bona fide prescription or other order of a licensed veterinarian. Sale of a animal prescription drug product to a layperson, except on a prescription or on order of a licensed practitioner, causes the product to be misbranded and subjects the seller to civil and/or criminal provisions of the Act.

A licensed veterinarian may legally use or dispense an animal prescription drug product only within the course of his/her professional practice where a valid veterinarian-client-patient relationship exists. Veterinarians employed by drug manufacturers or distributors may not legally dispense prescription drug products to laypersons unless they meet the above criteria. Similarly, practicing veterinarians or their employees may not legally sell animal prescription drug products to walk-in customers unless the same criteria are met. Federal regulations require that drug manufacturers provide at least the following information on the label of the finished package form of animal prescription drug products:

What information needs to be on the package label of animal Rx drugs?

• the statement, "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian;"
• recommended or usual dosage;
• route of administration, if it is not for oral use;
• quantity or proportion of each active ingredient as well as the information required by section 502(e) of the Act;
• names of inactive ingredients if it is for other than oral use;
• an identifying lot or control number from which it is possible to determine the complete manufacturing history of the drug.

What needs to be included in the veterinarian’s prescription and included on the label of the dispensed product?

• name and address of the dispenser;
• serial number and date of the order or its filling;
•  name and address of the veterinarian who prescribed or ordered the drug product;
• directions for use; and
• any necessary warning and precautionary statements including withdrawal times.

Any additional requirements of State or local laws for dispensed animal drug products must also be followed.

To protect themselves and their clients, veterinarians should make efforts to ensure their instructions are followed, especially when they prescribe or recommend drugs for food-producing animals that require a withdrawal period.

New Mexico Board of Pharmacy is Considering Amendment to Dangerous Veterinary Drugs-Retail Distribution

During the August 27, 2012, New Mexico Board of Pharmacy meeting, the board considered an amendment to 16.19.15 regarding Dispensing Dangerous Veterinary Drugs-Retail Distribution.  The minutes to that meetings can be viewed here.  The red lined version of the amendment can be viewed here.

Is Reform of How Animal Drugs are Regulated Needed?

The American Veterinary Medical Association has a question and answer page on its website that can be found  here and below. The questions and answers deal with why a pet owner should not buy over-the-counter (OTC) medications without first discussing it with a veterinarian. The improper use of drugs such as antibiotics can result in drug resistance for certain bacteria.  Why is it that some drugs for animals can be purchased OTC but those same types of drugs cannot be purchased for humans OTC?  Should the FDA treat drugs for animals different than drugs for humans?   Should the FDA take action against businesses that sell these types of drugs such as OTC antibiotics for animals?   Should veterinarians be allowed to compound drugs in their office or should they be required to write a prescription and have a pharmacist fill it? 

Q:

  Why do I need a prescription?

A:

  When you are given a prescription for a medication for your pet, it means that your veterinarian has made a decision that the medication is recommended or necessary to treat your pet's health problem. Many prescription drugs are only effective for specific problems, and may actually be harmful to your pet if used without that critical veterinary examination and diagnosis. Having these drugs available as prescription-only medications ensures that they are used appropriately.

Let's take heartworm preventives as an example. Heartworm preventives are labeled as "prescription-only" because it's critical that your veterinarian makes sure the medication is the right one based on your pet's health status. The preventives target the infective larvae as they are migrating through the tissue prior to reaching the bloodstream and developing to adult heartworms. If your dog (or cat) has heartworms, giving a preventive medication will not effectively treat the disease because the preventives don't readily kill adult heartworms. In some cases, administering preventives to heartworm positive dogs can cause a rapid kill of circulating microfilariae, leading to a life-threatening anaphylactic reaction.

There are drugs, called "over the counter" (OTC) drugs, that don't require prescriptions. Drugs can be bought OTC when the Food and Drug Administration (FDA) determines that the directions for the drug's use aren't overly complicated and are adequate for the public to follow. In some cases, such as the common headache medications for people, the OTC version is just a weaker strength than the prescription form. However, in many cases, a medication is only available with a prescription for the reasons we mention above.

***

Q:

  Why are some spot-on flea and tick preventive medications only available through my veterinarian?

A:

  Some manufacturers have decided to sell their products only through veterinarians so that the veterinarian and pet owner can discuss the situation and work together to determine the best flea and tick treatment for that pet. It's not that the product is "prescription-only" – it's that the manufacturer believes the product should only be sold through veterinarians. In addition, it seems more likely that the product will be used properly (for example, a cat won't be treated with a product labeled only for use in dogs) if the veterinarian is supplying the medication and is counseling the pet owner on the proper use of the medication.

If the spot-on flea and tick product is also labeled for heartworm prevention, it is only available through your veterinarian for the reason we previously described – it is critical that your veterinarian checks for a heartworm infection before your pet is given a heartworm preventive medication.

Q:

  My veterinarian gave me a prescription for a pain reliever for my pet. Why can't I just buy one of the over-the-counter pain relievers at my local drug store?

A:

  Don't do it! Although these products are approved for use in people, many of them are not safe for pets. For example, acetaminophen (Tylenol® is the most common example) can cause severe illness, and even death, in pets. Talk to your veterinarian before you give ANY medication to your pet.

Q:

  Where can I get my pet's prescriptions filled?

A:

  You have several options when your pet needs a prescription medication:

• You can get it from your veterinarian if they keep it in stock;
• Your veterinarian can write (or call in) a prescription to a local pharmacy that stocks the medication;
• Or your veterinarian can provide a prescription so you can get the medication from an online pharmacy.

Q:

  Can I get my pet's prescription medications from Canada?

A:

  No. Drugs from Canada are not approved by the federal government for use in the United States. It is illegal for you to get medications shipped from Canada for yourself or your pet.

Q:

  The pharmacy told me I don't need a prescription for a medication. Is that true? 

A:

  For some OTC medications, it is true. However, if your veterinarian tells you that you need a prescription for the medication but the pharmacy tells you that you don't need it, this might indicate that the pharmacy's staff is either confused or misinformed, or the pharmacy's ethics and standards are questionable. If this happens, talk to your veterinarian, contact the state board of pharmacy, or contact the U.S. Food and Drug Administration Center for Veterinary Medicine (FDA CVM)

Q:

  Why should I consider getting my pet's medications from my veterinarian?

A:

  There are several reasons you should consider getting your pet's medications from your veterinarian:

• If your veterinarian has the medication in stock, you immediately have it and you don't have to wait to get it from a pharmacy;
• Your veterinarian or a veterinary technician can answer your questions, provide you with instructions for use, and maybe even demonstrate how to give your pet the medication;
• If you order from a pharmacy and the medication isn't properly shipped (for example, it is allowed to get too hot or too cold) or isn't properly packaged, it could be ineffective or damaged and unusable; whereas if you get it from your veterinarian, you know it has been properly handled until it reaches you and they can inform you how to make sure you handle the medication properly.

Q:

  If I choose to get my pet's prescriptions filled elsewhere, can my veterinarian refuse to give me a prescription?

A:

  Your veterinarian might strongly recommend that you get the medication directly from them, but some states actually require veterinarians to write prescriptions for clients to have filled elsewhere if requested by the client. Some states do not require this of veterinarians.

There are certainly situations where it is in your pet's best interest to get the medication directly from your veterinarian, and we encourage you to discuss your options with your veterinarian. The AVMA's Principles of Veterinary Medical Ethics recommends that veterinarians comply with their client's wishes and provide written prescriptions if the client prefers having the prescription filled elsewhere.

Q:

  Can my veterinarian charge me a fee for writing a prescription for my pet?

A:

  There is no federal law preventing your veterinarian from charging you a fee for their services and time invested in writing a prescription. Some veterinarians charge a nominal fee for writing prescriptions, but others don't. Individual states might have specific guidance for veterinarians on prescription fees.

Q:

  My veterinarian is telling me that I have to bring my pet in for an examination before they'll write a prescription or authorize a refill. Why?

A:

  According to the AVMA Principles of Veterinary Medical Ethics, it is unethical, and in most states, unlawful, for a veterinarian to write a prescription or dispense a prescription drug outside a Veterinarian-Client-Patient Relationship (VCPR). For more information about the VCPR, including a definition, see Section III of the AVMA's Principles of Veterinary Medical Ethics. For a simpler explanation of the VCPR, read our "Frequently Asked Questions by Pet Owners about the Veterinarian-Client-Patient Relationship."

In order to maintain a VCPR, your veterinarian must see your pet regularly – how regularly they need to see your pet depends on your pet's health. If your pet is on a prescription medicine, your veterinarian may need to reexamine your pet, check blood work, or perform other tests to monitor your pet's response to treatment and determine if the medication needs to be changed. For example, a dog being treated for hypothyroidism needs to be reevaluated regularly to make sure the dosage is having the effect it needs to have.

Q:

  If I choose to get my pet's prescription filled elsewhere, will my veterinarian refuse to see my pet anymore?

A:

  That's not likely. We encourage you to talk to your veterinarian about your concerns and discuss what's best for your pet.

Q:

  Why do some medications cost more from my veterinarian than from an online store? 

A:

  Online pharmacies may buy larger volumes of the medications at a time, so they may get bulk pricing that might be lower (or much lower) than your veterinarian pays - so, even with a markup, some medications from an online source are being sold to you for less than your veterinarian pays to get the medication. Anybody who keeps medications in stock has to mark up the prices above what they paid because of the overhead costs involved in keeping those medications on the shelf and the losses if the medication expires and has to be discarded.

Q:

  What are the risks of ordering from an online pharmacy?

A:

  The amount of risk depends on the quality of the pharmacy. Human error is a risk with any source, but the risk is minimal if the proper procedures are in place.

When you order from an online pharmacy, the product must be shipped to you. If the medication isn't properly shipped (for example, it is allowed to get too hot or too cold) or isn't properly packaged, it could be ineffective or damaged and unusable.

If there is a problem with the medication received from an online pharmacy, there might be a period of time when your pet isn't getting its medication while you wait for the replacement medication to arrive.

Q:

  How do I know the pharmacy is trustworthy?

A:

  Prior experience with a pharmacy is a good indication – ask your veterinarian if there is a pharmacy they recommend. You can also inquire with the state board of pharmacy to determine whether a pharmacy is licensed within the state and the status of the pharmacy's license.

In addition, accreditation by independent bodies can give you more information about an online pharmacy. Two examples of third-party accreditation include the National Association Boards of Pharmacy Vet-VIPPS program and, for compounding pharmacies, the Pharmacy Compounding Accreditation Board. (Your prescription might be called in to a compounding pharmacy if your pet needs a medication tailored just for him or her – an example would be a flavored liquid medication for a cat who otherwise won't take the medication. It is NOT legal, however, to have a compounding pharmacy make a "cheaper" version of an identical product that has been approved by the FDA.)

Q:

  How will I know if there are problems with the medications I get from a pharmacy?

A:

  First of all, talk to your veterinarian about the signs of a problem with the medication. Make sure you know what to look for, and what to do if you see it. Don't hesitate to contact your veterinarian if you are concerned that your pet is having a problem with or a reaction to the medication.

If you receive a shipped medication and the package is damaged or it appears to have been allowed to get too hot or too cold, contact the pharmacy immediately and notify them of the problem. If you are not sure if the medication is safe to use in that condition, contact your veterinarian.

If you have concerns or complaints about a pharmacy's practices or the quality of its products, you can report the pharmacy to your state board of pharmacy.

Q:

  My veterinarian said that my pet needs to get a different dose than what the drug package insert says. Is this legal?

A:

  If your veterinarian thinks the labeled dose isn't right for your pet but a different dose is what your pet needs, this is a federally regulated activity called "extralabel drug use." Basically, if the medication is used in any other way than the label dictates, this is extralabel use, and it is legal as long as your veterinarian follows the regulations. Your veterinarian can also prescribe a human medication for your pet, and this is also considered extralabel use.

Please note that we're only talking about extralabel drug use in pets here. Extralabel use is legal in food-producing animals, but the rules are much more strict.

This FAQ was produced by the AVMA Scientific Activities and Communications Divisions, with assistance from the Council on Biologic and Therapeutic Agents and the Clinical Practitioners Advisory Committee.

Additional resources:

US Food and Drug Administration (FDA)

• Purchasing Pet Drugs Online: Buyer Beware (video)
• Online Pet Pharmacies: Protect Yourself and Your Pet: Be Online Pet Pharmacy A.W.A.R.E.