Plain language analysis
This proposed rule-making will conform a pharmacy practice rule to recent statutory changes brought about by
2005 Wisconsin Act 195. In instances when a drug product equivalent is dispensed, the Act permits inclusion on the label of both the generic name and the brand name of the drug product equivalent specified in the prescription order. The brand name must be omitted from the label if the prescribing practitioner requests that it be omitted.
Comparison with federal regulation
There is no existing or proposed federal regulation for summary and comparison.
Comparison with rules in adjacent states
Iowa: Iowa Admin. Code r. 657-6.(10)(1), does not allow a container label to identify a name of a drug product other than that dispensed.
Illinois: 225 Ill. Comp. Stat. 85/25, does not allow a container label to identify a name of a drug product other than that dispensed. No administrative code provision exists.
Michigan: Mich. Admin. Code r. 338.479 (3), allows that if a drug is dispensed that is not the brand prescribed, the purchaser shall be notified and the prescription label shall indicate both the name of the brand prescribed and the brand dispensed. If the dispensed drug does not have a brand name, the label shall indicate the name of the brand prescribed followed by the generic name of the drug dispensed or the reference “G.Eq.," “generic," or “generic equivalent" in the case of multi-ingredient products. This does not apply when the prescriber indicates, “do not label."
Minnesota: Minn R. 6800.3400, the label must contain the generic or trade name of a drug and its strength, except when specified by the prescriber to the contrary.
Summary of factual data and analytical methodologies
The proposed rule will conform a pharmacy practice rule to recent statutory changes brought about by
2005 Wisconsin Act 195, which created Wis. Stat. s.
450.11 (4g) (b). Section
Phar 7.02, Wis. Adm. Code, is therefore being amended for conformity with statute.
Analysis and supporting documents used to determine effect on small business
The board did not consult supporting documents other than
2005 Wisconsin Act 195. It is merely updating its rules based on the legislative change.
Section
227.137, Stats., requires an “agency" to prepare an economic impact report before submitting the proposed rule-making order to the Wisconsin Legislative Council. The Department of Regulation and Licensing is not included as an “agency" in this section.
Initial Regulatory Flexibility Analysis
These proposed rules will have no significant economic impact on a substantial number of small businesses, as defined in s.
227.114 (1), Stats. The Department's Regulatory Review Coordinator may be contacted by email at
larry.martin@drl.state.wi.us, or by calling (608) 266-8608.
Anticipated Costs Incurred by Private Sector
The department finds that this rule has no significant fiscal effect on the private sector.
Fiscal Estimate
The department estimates that the proposed rule will have no significant fiscal impact.
Agency Contact Person
Pamela Haack, Paralegal, Department of Regulation and Licensing, Office of Legal Counsel, 1400 East Washington Avenue, Room 152, P.O. Box 8935, Madison, Wisconsin 53708-8935; telephone 608-266-0495; email
pamela.haack@drl.state.wi.us.
Text of Rule
SECTION 1. Phar 7.02 is amended to read:
Phar 7.02 Prescription label; name of drug or drug product dispensed. No prescription drug
product may be dispensed unless the prescription label discloses the brand name and strength, or the generic name, strength, and manufacturer or distributor of the drug or drug product dispensed unless the prescribing practitioner requests omission of the above information. The prescription label shall not contain the brand or generic name of any drug or drug product other than that actually dispensed. If a pharmacist, pursuant to a prescription order that specifies a drug product by its brand name, dispenses the drug product equivalent of the drug product specified in the prescription order, the prescription label may include both the generic name of the drug product equivalent and the brand name specified in the prescription order, unless the prescribing practitioner requests that the brand name be omitted from the label. If a brand name drug product is dispensed, the prescription label may contain both the brand name and the generic name of the drug product equivalent dispensed unless the prescribing practitioner requests that the generic name of the drug product equivalent be omitted from the label.
Notice of Hearing
Pharmacy Examining Board
NOTICE IS HEREBY GIVEN that pursuant to authority vested in the Pharmacy Examining Board in ss.
15.08 (5) (b),
227.11 (2) and
450.02 (3) (a),
(b),
(d) and
(e), Stats., and interpreting s.
450.02 (3) (a),
(b),.(d) and (e), Stats., the Pharmacy Examining Board will hold a public hearing at the time and place indicated below to consider an order to repeal Phar 7.015 (3) (d); and to create Phar 7.015 (2) (q), relating to the transfer of a prescription drug by a pharmacy technician.
Hearing Information
Date: December 5, 2007
Time: 9:30 a.m.
Location: 1400 East Washington Avenue
(Enter at 55 North Dickinson Street)
Room 121A
Madison, Wisconsin
Appearances at the Hearing and Submission of Written Comments
Interested persons are invited to present information at the hearing. Persons appearing may make an oral presentation but are urged to submit facts, opinions and argument in writing as well. Facts, opinions and argument may also be submitted in writing without a personal appearance by mail addressed to Pamela Haack, Paralegal, Department of Regulation and Licensing, 1400 East Washington Avenue, Room 152, P.O. Box 8935, Madison, Wisconsin 53708-8935, or by email at
pamela.haack@drl.state.wi.us. Comments must be received on or before December 7, 2007 to be included in the record of rule-making proceedings.
Analysis Prepared by Department of Regulation and Licensing
Statutes interpreted
Statutory authority
Explanation of agency authority
The Wisconsin Pharmacy Examining Board is granted the authority to protect the public health, safety and welfare by establishing minimum standards for the practice of pharmacy, which includes the practice activities for a pharmacist and for a pharmacy technician.
Related statutes or rule
Plain language analysis
Chapter
Phar 7 defines mandatory and permissible pharmacy practice activities for a pharmacist and for a pharmacy technician. The proposed rule change would amend provisions of the current rule that relate to when and how a technician may transfer a prescription to a patient or agent of a patient.
Rules of the Pharmacy Examining Board identify in s.
Phar 7.015 that pharmacy technicians may be assigned by a pharmacist certain tasks relating to receiving prescriptions and preparing and dispensing drugs. The proposed modification will clarify that a pharmacy technician may permissibly transfer a prescription order to a patient or an agent of the patient if the pharmacist has first provided a patient consultation.
SECTION 1 creates a provision allowing a pharmacy technician to transfer a prescription order to a patient or an agent of the patient if a pharmacist has first provided a patient consultation.
SECTION 2 repeals a provision prohibiting a pharmacy technician from transferring a prescription order to a patient or an agent of the patient.
Comparison with federal regulations
There is no existing or proposed federal regulation for summary and comparison.
Comparison with rules in adjacent states
Iowa: Rules: Although not explicitly addressed, by implication the transfer of prescriptions to patients is allowed as a delegated act by the pharmacist when the pharmacist is present in the pharmacy. Iowa Admin. Code r. 657-3.21, requires the pharmacist to be on site when delegating to technicians. Iowa Admin. Code r. 657-3.23, prohibits a technician from counseling but not from transferring the prescription. Iowa Admin. Code r. 657-3.22, the transfer of the prescription is not included in a list of technical functions a technician may perform, but the list is not exhaustive. Iowa Admin. Code r. 657-6.7(3), prohibits non technical dispensing activities in the absence of the pharmacist.
Illinois: Rules: Ill. Admin. Code tit. 68 § 1330.80, requires a pharmacist to be present when a prescription is distributed to the ultimate consumer. By implication a prescription transfer may occur from the technician to a patient as a non discretionary act.
Michigan: Rules: Mich. Admin. Code r. 338.490(5), outlines what a pharmacist shall do in delegating without specifying what can or cannot be delegated. Written procedures must be provided to the delegate. By implication the transfer of prescriptions to patients by technicians is allowed as a delegated act by the pharmacist.
Minnesota: Rules: Minn R. 6800.3100, does not include transfer in the list of what shall be done by the pharmacist. Minn R. 6800.3850, allows technicians to perform technician functions that do not involve professional pharmaceutical judgment. Technician tasks must be included as part of a pharmacy's written procedures. By implication a prescription transfer may occur from the technician to a patient as a non discretionary act.
Summary of factual data and analytical methodologies
The Pharmacy Examining Board has been made aware from reports from the profession and from investigations undertaken by the Department of Regulation and Licensing's Division of Enforcement, that in certain circumstances pharmacy technicians have been physically handing a prescription order to the patient and concluding the sale of the prescription order to the patient, after a pharmacist has provided a patient consultation to the patient or agent of the patient. The strict reading of s.
Phar 7.015 (3) (d) prohibits the pharmacy technician from transferring a prescription order under any circumstances. The board is therefore aware of the need to clarify this rule provision to clearly state that such a transfer of the prescription to the patient or agent of the patient is permissible provided that the pharmacist has first provided a patient consultation. Adjacent states allow the practice.
Analysis and supporting documents used to determine effect on small business
The board discussed the anticipated effect on pharmacies and decided that delegating the actual transfer without delegating the consultation would result in greater efficiencies for pharmacies. Some small businesses may benefit from the marginal increase in pharmacist availability for other tasks.
Section
227.137, Stats., requires an “agency" to prepare an economic impact report before submitting the proposed rule-making order to the Wisconsin Legislative Council. The Department of Regulation and Licensing is not included as an “agency" in this section.
Initial Regulatory Flexibility Analysis
These proposed rules will have no significant economic impact on a substantial number of small businesses, as defined in s.
227.114 (1), Stats. The Department's Regulatory Review Coordinator may be contacted by email at
larry.martin@drl.state.wi.us, or by calling (608) 266-8608.
Anticipated Costs Incurred by Private Sector
The department finds that this rule has no significant fiscal effect on the private sector.
Fiscal Estimate
The department estimates that the proposed rule will have no significant fiscal impact.
Agency Contact Person
Pamela Haack, Paralegal, Department of Regulation and Licensing, Office of Legal Counsel, 1400 East Washington Avenue, Room 152, P.O. Box 8935, Madison, Wisconsin 53708-8935. Telephone: (608) 266-0495. Email:
pamela.haack@drl.state.wi.us.
Text of Rule
SECTION 1. Phar 7.015 (2) (q) is created to read:
Phar 7.015 (2) (q) Transferring the prescription to the patient or agent of the patient, provided that the pharmacist has first provided a patient consultation.
SECTION 2. Phar 7.015 (3) (d) is repealed.
Notice of Proposed Rulemaking
Regulation and Licensing
NOTICE IS HEREBY GIVEN that pursuant to ss.
227.11 (2) and
458.24, Stats., and interpreting ss.
458.24 and
458.26 (3) (b), Stats., and according to the procedure set forth in s.
227.16 (2) (e), Stats., the Department of Regulation and Licensing will adopt the following rules as proposed in this notice, without public hearing unless, within 30 days after publication of this notice, on
November 15, 2007, the Department of Regulation and Licensing is petitioned for a public hearing by 25 natural persons who will be affected by the rule; a municipality which will be affected by the rule; or an association which is representative of a farm, labor, business or professional group which will be affected by the rule.
Analysis Prepared by the Department of Regulation and Licensing
Statutes interpreted
Statutory authority
Explanation of agency authority
The Department of Regulation and Licensing is authorized under ss.
227.11 (2) and
458.24, Stats., to promulgate rules establishing the standards for appraisal practice for licensed and certified appraisers.
Related statutes or rules
Plain language analysis
