Notice of Comments Issued [32 Pa.B. 4406] Section 5(d) of the Regulatory Review Act (Act) (71 P. S. § 745.5(d)) provides that the designated standing Committees may issue comments within 20 days of the close of the public comment period, and the Independent Regulatory Review Commission (Commission) may issue comments within 10 days of the close of the Committee comment period. The Commission's comments are based upon the criteria contained in section 5.1(h) and (i) of the Act (71 P. S. § 745.5a(h) and (i)).
The Commission has issued comments on the following proposed regulations. The agency must consider these comments in preparing the final-form regulation. The final-form regulation must be submitted within 2 years of the close of the public comment period or it will be deemed withdrawn.
Reg No. Agency/Title Close of the Public Comment Period IRRC
Comments
Issued#16A-5712 State Board of Veterinary Medicine
Professional Conduct; Prescription Drugs7/22/02 8/22/02 (32 Pa.B. 2997 (June 22, 2002)) #6-274 Professional Standards and Practices Commission
Definitions of Statutory Terms7/22/02 8/22/02 (32 Pa.B. 2994 (June 22, 2002)) ____ State Board of Veterinary Medicine Regulation
No. 16A-5712Professional Conduct; Prescription Drugs August 22, 2002 We submit for consideration the following objections and recommendations regarding this regulation. Each objection or recommendation includes a reference to the criteria in the Regulatory Review Act (71 P. S. § 745.5a(h) and (i)) which have not been met. The State Board of Veterinary Medicine (Board) must respond to these Comments when it submits the final-form regulation. If the final-form regulation is not delivered within years of the close of the public comment period, the regulation will be deemed withdrawn.
Section 31.21. Rules of Professional Conduct for Veterinarians.
Principle 8. Drugs.
1. Subsection (a)--Definitions of ''drug'' and ''prescription drug''--Clarity.
In the version of the proposed rulemaking published in the Pennsylvania Bulletin, the definition of ''drug'' in subsection (a)(1) includes the phrase ''[f]or the purposes of Principle 8, the term 'drug' means . . . .'' The definition of ''prescription drug'' appears separately in subsection (a)(2). However, subsection (a)(2) does not contain the phrase ''for the purposes of Principle 8.'' In the final-form regulation, the phrase ''for the purposes of Principle 8'' should be added to subsection (a)(2).
2. Subsection (b)--''Under the veterinarian's care''--Clarity.
This subsection contains a definition for the phrase ''under the veterinarian's care.'' The second sentence of the subsection defines the phrase and begins with the words: ''For the purposes of this section. . .'' (emphasis added). The phrase ''under the veterinarian's care'' does not appear in the other Principles in § 31.21. Should the word ''section'' be replaced with ''Principle 8''?
3. Subsection (d)(6)--Cautionary statements required by Federal law--Clarity.
This subsection references ''the Federal Food, Drug and Cosmetic Act (21 U.S.C.A. §§ 301--397) and 21 CFR (relating to food and drugs).'' Title 21 of the CFR contains over 1,400 parts. This reference should identify the specific sections, parts or other provisions that are pertinent to cautionary statements that must be added to animal drug labels. Federal regulations may be incorporated by reference under 1 Pa.C.S. § 1937, 45 Pa.C.S. § 727 and 1 Pa. Code § 3.41.
4. Subsection (f)--Written prescriptions--Reasonableness; Need; Clarity.
This subsection requires a veterinarian to provide a client with a written prescription upon request from the client. The subsection includes an exemption from the requirement if the veterinarian has ''a good faith belief that the prescription may be misused.''
According to the Preamble, this exemption was included in response to concerns from commentators who work with farm animals. Veterinarians who dispense drugs in large, multiple doses were concerned that unless they dispensed the drugs themselves, it would be ''impossible for the veterinarian to have even minimal knowledge or control over the remaining quantity or expiration date of the drug.''
We question the need for the ''good faith belief'' exemption. The veterinarian determines whether medication is necessary and directs the course of the medication therapy. In the prescription, the veterinarian determines the substance, quantity, dosage and amount of refills, if any. Where the prescription is filled is an unrelated issue. Therefore, unless the Board can justify the need for this exemption, it should delete it from the final-form regulation.
Second, how will clients or consumers be notified that they can request written prescriptions rather than paying for drugs dispensed directly by veterinarians? The final-form regulation should require veterinarians to notify clients that they have the option of receiving a written prescription that can be filled elsewhere.
5. Recordkeeping.--Clarity.
The regulation should reference the recordkeeping requirements in § 31.22 and the specific recordkeeping requirements for controlled substances in Federal regulations at 21 CFR Part 1304.
____ Professional Standards and Practices Commission Regulation No. 6-274 Definitions of Statutory Terms August 22, 2002 We submit for consideration the following objections and recommendations regarding this regulation. Each objection or recommendation includes a reference to the criteria in the Regulatory Review Act (71 P. S. § 745.5a(h) and (i)) which have not been met. The Professional Standards and Practices Commission (Commission) must respond to these Comments when it submits the final-form regulation. If the final-form regulation is not delivered within 2 years of the close of the public comment period, the regulation will be deemed withdrawn.
Section 237.3. Immorality--Reasonableness; Clarity.
Morals of the Commonwealth
This section defines the term ''immorality'' as ''. . .conduct which offends the morals of the Commonwealth. . . .'' (Emphasis added.) The phrase ''morals of the Commonwealth'' is undefined and vague. Moreover, Pennsylvania is comprised of many diverse communities. Given the Commission's authority to discipline professional educators and charter school staff members which it has found guilty of ''immorality,'' standards of conduct should be established in clear and explicit terms.
Section 237.9. Crimes involving moral turpitude.--Clarity.
Moral turpitude
Subsection (a)(1) contains the following language used to describe the phrase ''moral turpitude'': ''private and social duties which a person owes to his fellow human beings or to society in general'' and ''an act of baseness, vileness or depravity, and contrary to the accepted and customary rule of right and duty between two human beings.''
This language is derived from case law. However, one of the purposes of regulations is to clarify the language used in both statutes and case law. Clarity would be improved by describing with more precision the actions which constitute ''moral turpitude,'' or providing examples in the final-form regulation.
Specific crimes
Subsection (c) sets forth a mechanism for the Commission to consider crimes added or deleted from the list of crimes in section 111(e)(1) of the Public School Code of 1949 to determine if the crimes involve moral turpitude per se. The process states ''The Commission will consider each additional or deleted crime to determine if the crime involves moral turpitude per se and will vote at a public meeting whether the crime will be designated as involving moral turpitude per se.'' We have two concerns.
First, the final-form regulation should specify how the Commission's decisions regarding crimes that are added or deleted to the list will be made available to the public. For example, will the Commission periodically publish a list of crimes that are considered crimes involving moral turpitude?
Second, the criteria the Commission will use for determining whether a crime involves moral turpitude per se are unclear. The Commission should include criteria for making this determination in the final-form regulation.
JOHN R. MCGINLEY, Jr.,
Chairperson[Pa.B. Doc. No. 02-1572. Filed for public inspection September 6, 2002, 9:00 a.m.]
