RULES AND REGULATIONS
STATE BOARD OF VETERINARY MEDICINE
[49 PA. CODE CH. 31]
Rules of Professional Conduct for Veterinarians
[33 Pa.B. 5920] The State Board of Veterinary Medicine (Board) adopts an amendment to § 31.21 (relating to Rules of Professional Conduct for Veterinarians) to read as set forth in Annex A.
Notice of proposed rulemaking was published at 32 Pa.B. 2997 (June 22, 2002). Publication was followed by a 30-day public comment period during which the Board received one comment. On August 9, 2002, the House Professional Licensure Committee (HPLC) informed the Board that it would not be submitting comments to the proposed rulemaking. The Senate Consumer Protection and Professional Licensure Committee (SCP-PLC) made no comments. The Independent Regulatory Review Commission (IRRC) submitted comments to the proposed rulemaking on August 22, 2002.
Summary of Comments and Responses to Proposed Rulemaking
IRRC Comments
IRRC pointed out an inconsistency in the introductory language to definitions for ''drug,'' ''prescription drug'' and ''under the veterinarian's care.'' On some occasions, the Board prefaced the definition by stating the definition was applicable only for a particular subsection. The Board finds that these definitions are generally applicable to all of § 31.21, and strikes the prefatory language ''for purposes of this section'' in the final-form rulemaking.
Regarding proposed § 31.21, Principle 8(d)(6), IRRC requested the Board's references to the Federal Food, Drug and Cosmetic Act (21 U.S.C.A. §§ 301--397) and 21 CFR (relating to food and drugs) be made more specific as to what sections of the law and what parts of the Code of Federal Regulations apply. Upon review of IRRC's comments and concerns, the Board has determined that this subsection should be revised. First, veterinarians have an affirmative duty to comply with Federal and State laws and regulations pertaining to all aspects of drug dispensing including labeling. Thus, as IRRC suggested, the subsection would not provide necessary or useful information to the practicing veterinarian. Additionally, the specificity suggested by IRRC would require the Board to revise its regulations whenever the Federal government made substantial changes. Veterinarians receive training in both State and Federal drug labeling requirements and the Board's regulation does not need to specify the many State and Federal laws and regulations in this area. Therefore, the Board strikes all references to Federal laws and regulations.
Principle 8(f) would have required a veterinarian to provide a client with a written prescription, rather than dispense a drug, if the client requested a prescription. Principle 8(f) also provided that the veterinarian would not be subject to discipline if the veterinarian refused to give the client a written prescription because the veterinarian had a good faith belief that the prescription might be misused. IRRC questioned ''the need for the 'good faith belief' exemption,'' and stated that where a prescription was filled was an issue unrelated to whether the medication was necessary.
The good faith exemption applied to situations when the veterinarian had ''a good faith belief that the prescription would be misused.'' Any health care practitioner, including a veterinarian, with the authority to dispense or prescribe medications may legally refuse to give a prescription to a patient or client if the practitioner has a good faith belief the prescription may be misused. A veterinarian is only permitted to prescribe ''in good faith in the course of his professional practice.'' See section 111(e)(i) of The Controlled Substance, Drug Device and Cosmetic Act (35 P. S. § 780-111(e)(i)). If a veterinarian cannot in good faith give a client a written prescription because the veterinarian believes the prescription may be misused, the veterinarian may not provide a written prescription. The good faith exception is consistent with other State law.
The Board considered several types of possible misuse of a written prescription. First, a client might misuse a prescription by failing to promptly fill the prescription and administer the medication. In this case, dispensing the drug rather than issuing a written prescription would ensure that the animal's treatment began in a timely manner and the special duty of a veterinarian to attend to the welfare of the animal patient would be fulfilled. In the judgment of the professional members of the Board regarding the prescribing, dispensing and use of drugs in veterinary medicine, a veterinarian must have the ability to refuse to issue a prescription where in the veterinarian's professional judgment it would be detrimental to the health of the animal or the public welfare.
Second, the Board considered the possibility that a client could misuse a prescription by altering the prescribed quantity to use the medication on animals that are not under the veterinarian's care, to use more than the prescribed amount on the animal for which the medication was prescribed, to sell the medication to others or to misuse the medication himself.
Third, the Board was cognizant of the responsibilities of a veterinarian that go beyond animal patient and the owner-client. For example, veterinarians who work with farm animals have a duty to protect this Commonwealth's milk and meat supply, and all veterinarians have a duty to protect the public health and welfare. The Board's regulation would not have changed the current law or acceptable and prevailing standards of veterinary medical practice and ethics. Therefore, the Board declined to strike the good faith exemption as proposed by IRRC.
IRRC further commented that the regulation would be improved by the addition of a provision in the final-form rulemaking that would require a veterinarian to notify clients that the clients could request a written prescription rather than a dispensed drug. IRRC's comment appears to be aimed at providing the consumer of veterinary services with options regarding the provision of drugs.
The Board gave careful consideration to IRRC's comment. The Board was concerned that it would be difficult to regulate a notice provision because of the variety of practice settings of veterinarians. For example, there is no equivalent in a mobile practice to posting a sign in the waiting room or examination room of a veterinary hospital. To require a veterinarian to provide oral notice would not be appropriate under certain circumstances. For example, if a client's terminally ill animal needed painkillers so that it could remain comfortable and the client could bring the animal home to die, it would be callous for the veterinarian to inquire whether the client wanted a written prescription. In addition, veterinarians, unlike physicians, are prohibited from selling professional veterinary products without a veterinarian/client relationship. See § 31.1 (relating to definitions) and § 31.21, Principle 3(d). Thus, depending on the type of medication, it may be difficult or impossible for the client to fill the prescription anyplace other than the prescribing veterinarian's office. In this case, it would be fruitless to require the veterinarian to notify the client that the client could obtain a written prescription. For these reasons, the Board declined to impose a general notice requirement on its licensees.
Finally, IRRC suggested that the regulation should reference the recordkeeping requirements in § 31.22 (relating to recordkeeping rationale) and the specific recordkeeping requirements for controlled substances in 21 CFR Part 1304 (relating to records and reports of registrants). The Board added a new section to the rulemaking specifying the duty of the veterinarian to keep appropriate records relating to drugs and prescription drugs and has added a new subsection to proposed Principle 8.
IRRC disapproved the Board's final-form rulemaking at its July 24, 2003, meeting. In its disapproval order, IRRC stated the following:
One issue, which we raised in our comments, remains a concern. Our comments suggested that the final-form regulation require veterinarians to inform clients that they have the option of receiving a written prescription that can be filled elsewhere. The Board did not include such a requirement in the final-form regulation.We believe that notification to the consumer of the opportunity to request a written prescription is in the public interest and will not impose an unreasonable burden upon veterinarians. (71 P. S. §§ 745.5b(b)(1)(i) and (ii), and (b)(3)).1We have determined this regulation is consistent with the statutory authority of the Board (63 P. S. § 485.5(2)) and the intention of the General Assembly. However, after considering all of the other criteria of the Regulatory Review Act discussed above, we find promulgation of this regulation is not in the public interest.Following IRRC's disapproval, the Board submitted a report to the Chairpersons of the HPLC and the SCP-PLC. The Board withdrew proposed subsection (f) to further study IRRC's concerns and whether the Board's regulations should include a notice requirement. The Board, following a suggestion by one Commissioner, also wished to further study what type of notice would be appropriate given: (1) the variety of settings in which veterinarians practice; (2) the health and welfare of the animals cared for by veterinarians; (3) the health and safety of the human public; and (4) the legality, availability and cost of obtaining veterinary drugs from sources other than from the treating veterinarian. Following submission of its report, IRRC met on September 25, 2003, and approved the amended final-form rulemaking, noting: ''We must assert that we are very displeased with the deletion of the written prescription provision. As stated previously, we were looking for further improvement of this provision, not its deletion.'' IRRC urged the Board to publish a proposed rulemaking addressing the written prescription and public notice issues at the earliest possible opportunity. The HPLC also approved the amended final-form rulemaking.
Public Comment
The Board received one comment from the public regarding the proposed rulemaking from the Pennsylvania Society for Biomedical Research (Society). The Society stated that the proposed rulemaking ''would not and cannot apply to'' persons exempted from section 32(5) of the Veterinary Medical Practice Act (act) (63 P. S. § 485.32(5)) and that ''no rule or regulation issued by the State Board of Veterinary Medicine under 49 Pa. Code Ch. 31 applies to'' any persons exempted from section 32(5) of the act. The Board concurs that none of its regulations are enforceable against unlicensed persons exempted by this section of the act. However, if persons exempted from the act choose to be licensees of the Board, the Board believes that the act and its regulations would apply to those persons.
Statutory Authority
This final-form rulemaking is authorized under section 5(2) of the act (63 P. S. § 485.5(2)). Section 5(2) of the act empowers the Board to adopt regulations regarding professional conduct.
Fiscal Impact and Paperwork Requirements
This final-form rulemaking will have no fiscal impact on the Commonwealth or its political subdivisions. This final-form rulemaking will create no additional paperwork for the Board or the private sector.
Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), the Board submitted a copy of the notice of proposed rulemaking, published at 32 Pa.B. 2997, to IRRC and to the HPLC and the SCP-PLC. In compliance with section 5(c) of the Regulatory Review Act, the Board also provided IRRC and the HPLC and the SCP-PLC Committees with copies of all comments received, as well as other documents.
Publication of the notice of proposed rulemaking was followed by a 30-day public comment period during which the Board received one comment from the public. The Board also received comments from IRRC. In preparing this final-form rulemaking, the Board has considered all comments received from IRRC and the public.
This final-form rulemaking was approved by the HPLC and the SCP-PLC on June 24, 2003. IRRC met on July 24, 2003, and disapproved the proposed rulemaking, citing section 5.2(b)(1)(i), (ii) and (3) of the Regulatory Review Act. On September 5, 2003, the Board delivered its report to IRRC under the Regulatory Review Act and an amended final-form rulemaking. IRRC approved the amended final-form rulemaking on September 25, 2003. On October 8, 2003, the HPLC met and approved the final-form rulemaking. The final-form rulemaking was deemed approved by the SCP-PLC on October 9, 2003.
Additional Information
Individuals who need information about the final-form rulemaking may contact Robert Kline, Administrative Assistant, State Board of Veterinary Medicine, P. O. Box 2649, Harrisburg, PA 17105-2649.
Findings
The Board finds that:
(1) Public notice of intention to adopt this final-form rulemaking was given under sections 201 and 202 of the act of July 31, 1968 (P. L. 769, No 204) (45 P. S. §§ 1201 and 1202) and the regulations promulgated thereunder, 1 Pa. Code §§ 7.1 and 7.2.
(2) A public comment period was provided as required by law and all comments were considered.
(3) The regulation of the Board is necessary and appropriate for the administration of the act.
(4) The amendments to this final-form rulemaking do not enlarge the original purpose of the proposal at 32 Pa.B. 2997.
Order
The Board orders that:
(a) The regulations of the Board, 49 Pa. Code Chapter 31, are amended by amending § 31.21 to read as set forth in Annex A, with ellipses referring to the existing text of the regulation.
(b) The Board shall submit the order and Annex A to the Office of Attorney General and the Office of General Counsel for approval as required by law.
(c) The Board shall certify this order and Annex A and shall deposit them with the Legislative Reference Bureau as required by law.
(d) This order shall take effect upon publication in the Pennsylvania Bulletin.
BRIAN V. HARPSTER, V.M.D.,
Chairperson(Editor's Note: For the text of the order of the Independent Regulatory Review Commission relating to this document, see 33 Pa.B. 5149 (October 11, 2003).)
Fiscal Note: Fiscal Note 16A-5712 remains valid for the final adoption of the subject regulation.
Annex A
TITLE 49. PROFESSIONAL AND VOCATIONAL STANDARDS
PART I. DEPARTMENT OF STATE
Subpart A. PROFESSIONAL AND OCCUPATIONAL AFFAIRS
CHAPTER 31. STATE BOARD OF VETERINARY MEDICINE
PROFESSIONAL CONDUCT § 31.21. Rules of Professional Conduct for Veterinarians.
Preamble The Board is empowered under section 5(2) of the act (63 P. S. § 485.5(2)) to adopt rules and regulations of professional conduct appropriate to establish and maintain a high standard of integrity, skill and practice in the profession of veterinary medicine. In accordance with this authority, the Board has determined that the following rules are necessary in the public interest to protect the public against unprofessional conduct on the part of veterinarians. The Board therefore adopts this professional conduct code for veterinarians practicing veterinary medicine in this Commonwealth. Some of the rules of conduct are imperatives, cast in the terms, ''shall'' or ''may not.'' Veterinarians who fail to adhere to these rules will be subject to professional discipline. Other rules, generally cast in the terms ''may'' or ''should,'' are intended as aspirational goals and define areas under which the veterinarian has professional discretion. No disciplinary action will be taken when a veterinarian acts within the bounds of discretion. References throughout this professional conduct code to imperative conduct on the part of veterinarians also apply to applicants for licensure and temporary permit holders where these persons render services under qualified supervision.
* * * * * Principle 8. Drugs.
(a)(1) The term ''drug'' means:
(i) Substances recognized in the official United States Pharmacopoeia, official National Formulary, or Federal Food and Drug Administration Approved Animal Drug Products, or any supplement to them.
(ii) Substances intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals.
(iii) Substances (other than food) intended to affect the structure or any function of the human body or other animal body.
(iv) Substances intended for use as a component of any substance specified in subparagraph (i), (ii) or (iii), but not including devices as that term is defined in section 2 of The Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. § 780-102).
(2) The term ''prescription drug'' means any drug required by Federal law, including Federal regulation, to be dispensed only by a prescription.
(b) A veterinarian shall only prescribe prescription drugs to animals that are under the veterinarian's care. ''Under the veterinarian's care'' means that the veterinarian or one of the veterinarian's licensed associates has examined the animal or has made medically appropriate and timely visits to the premises where the animal is kept.
(c) Prescription drugs dispensed by a veterinarian, other than drugs for food animals, shall be dispensed in child resistant packaging or in the manufacturer's original packaging, except when the client specifically requests other packaging.
(d) Prescription drugs dispensed by a veterinarian shall be labeled with, at a minimum, the following information:
(1) The name, address and telephone number of the prescribing veterinarian and the name and telephone number of the dispenser, if different.
(2) The brand or generic name of the drug.
(3) The potency and the quantity of the drug.
(4) The number of refills allowed, if any.
(5) Adequate directions for use, which shall include quantity of dose, frequency of administration or application, duration of administration or application, and route or method of administration or application.
(6) Any cautionary statement specified by the veterinarian or required by law.
(7) The name of the patient, if applicable.
(8) The date the drug was dispensed.
(9) The expiration date of the drug.
(e) Veterinarians shall dispense or administer only drugs, including prescription drugs, that are within the expiration date specified by the manufacturer, and shall dispense or administer only drugs that will not expire within the prescribed treatment period.
(f) Veterinarians shall maintain records related to drugs in accordance with § 31.22 (relating to recordkeeping rationale).
[Pa.B. Doc. No. 03-2312. Filed for public inspection December 5, 2003, 9:00 a.m.] _______
1 Section 5.2 of the Regulatory Review Act, 71 P. S. §§ 745.5b, relates to criteria for review of regulations. Sections 5.2(b)(1)(i) and (ii) of the Regulatory Review Act, 71 P. S. §§ 745.5b(b)(1)(i) and 745.5b(b)(1)(ii), empower the Commission to consider direct and indirect costs to the Commonwealth, to its political subdivisions and to the private sector and the adverse effects on prices of goods and services, productivity or competition, in determining whether a rulemaking is in the public interest. Section 5.2(b)(3) of the Regulatory Review Act, 71 P. S. § 745b(b)(3), empowers the Commission to consider the clarity, feasibility and reasonableness of the regulation in determining whether the regulation is in the public interest.
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