The proposed rule and fiscal estimate may be reviewed and comments electronically submitted at the following Internet site: adminrules.wisconsin.gov. Written comments on the proposed rule may be submitted via U.S. mail to Mr. Steve Dunn, Bureau of Air Management, P.O. Box 7921, Madison, WI 53707. Comments may be submitted until June 30, 2006. Written comments whether submitted electronically or by U.S. mail will have the same weight and effect as oral statements presented at the public hearings. A personal copy of the proposed rule and fiscal estimate may be obtained from Robert Eckdale, Bureau of Air Management, P.O. Box 7921, Madison, WI 53707.
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) (d), Stats., and interpreting ss.
450.02 (3) (d) and
(e) and
450.11 (8) (a), Stats., the Pharmacy Examining Board will hold a public hearing at the time and place indicated below to consider an order to amend Phar 8.02 (3) (f), relating to controlled substances theft and loss reporting requirements.
Hearing Date, Time and Location
Date: June 22, 2006
Time: 9:45 a.m.
Location: 1400 East Washington Avenue
(Enter at 55 North Dickinson Street)
Room 121A
Madison, Wisconsin
Appearances at the Hearing
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 the Department of Regulation and Licensing, Office of Legal Counsel, P.O. Box 8935, Madison, Wisconsin 53708. Written comments must be received by July 3, 2006, to be included in the record of rule-making proceedings.
Analysis prepared by the Department of Regulation and Licensing.
Explanation of agency authority: The board is authorized by statute to promulgate rules necessary for the administration and enforcement of chapters 450 and 961, Stats., and establishing minimum standards for the practice of pharmacy.
Related statute or rule: There are no related statutes or rules other than those listed above.
Plain language analysis: Wisconsin Administrative Code s.
Phar 8.02 (3) (f) currently requires pharmacies, practitioners and other federal drug enforcement administration (DEA) registrants authorized to possess controlled substances to notify the regional office of the DEA, the local police, and the Pharmacy Examining Board of
any theft or
any loss upon discovery. The DEA requires any theft to be reported but not any loss. Only significant losses must be reported to the DEA. The intent of this proposed rule change is to conform the state controlled substances theft and loss reporting requirement for pharmacies, practitioners or other DEA registrants to federal law. The proposed rule change will eliminate the reporting of drug losses, not based on theft, by pharmacies, practitioners or other DEA registrants if the losses are not considered significant under federal law.
SECTION 1 creates the requirement for the reporting of a loss or theft of a controlled substance to the board if a pharmacy, practitioner or other DEA registrant is required to file with the DEA a report of theft or loss of controlled substances.
Summary of, and comparison with, existing or proposed federal regulation:
Chapter
21 CFR 13.01.
74 (c) and 1301.76 (b). Federal law currently requires a DEA registrant to file a report with the DEA of any theft or significant loss of a controlled substance.
Comparison with rules in adjacent states:
Iowa
657—10.16(124) Report of theft or loss.
A registrant shall report in writing, on forms provided by the board, any theft or significant loss of any controlled substance upon discovery of the theft or loss. The report shall be submitted to the board office within two weeks of the discovery of the theft or loss. Thefts shall be reported whether or not the controlled substances are subsequently recovered or the responsible parties are identified and action is taken against them. A copy of the report shall be maintained in the files of the registrant.
Illinois
In every instance that a pharmacist-in-charge is required by federal law (
21 CFR 1301.76) to file with the U.S. Drug Enforcement Agency a Report of Theft or Loss of Controlled Substances, Form 106, a copy shall be sent to the Division. Failure to do so may result in discipline of the pharmacist.
Michigan
R 338.3141 Thefts and diversions.
Rule 41. (1) An applicant or licensee shall provide effective controls against theft and diversion of controlled substances.
(2) A licensee shall determine that a person is licensed to possess a controlled substance before distributing the substance to the person.
(3) Within 10 days following discovery of a theft or loss of any controlled substance, a licensee shall notify the administrator of the theft or loss by submitting a United States drug enforcement administration theft and loss report form 106, a copy thereof, or equivalent document, whether or not the controlled substance is subsequently recovered or the responsible party is identified and action is taken against the party, and whether or not it is also reported to the DEA.
Minnesota
6800.4800 Reporting Controlled Substance Losses.
Any pharmacy, drug wholesaler, drug manufacturer, or controlled substance researcher detecting the theft or significant loss of any controlled substance drug, where the loss is attributable to other than inadvertent error, must report the loss, in writing, to the board and to the Drug Enforcement Administration immediately. The report must include a description of how the loss occurred, if known, the date the loss occurred, if known, the steps being taken to prevent future losses, and an inventory of the missing drugs.
Summary of factual data and analytical methodologies:
Asserting there is no uniform, objective standard to determine whether a loss is significant, and therefore subject to reporting, the United States Drug Enforcement Administration (DEA) initiated rule-making to further define what constitutes a significant loss of controlled substances. A final rule became effective on September 12, 2005. In view of the federal amendment, the Pharmacy Examining Board reviewed the Wisconsin rule, which requires notification of the DEA, the local police, and the Wisconsin Pharmacy Examining Board of any theft or loss. After considering the usefulness of loss reports, ranging from small losses to carelessness or inadvertent error to larger losses incurred for a variety of reasons, an assessment of the statutes and rules of Wisconsin's neighbors, a comparison of the relative value of maintaining a state requirement that is more comprehensive than the federal protections, and the simplicity merits of a uniform reporting requirement, the board decided to follow the federal rule.
Analysis and supporting documents used to determine effect on small business or in preparation of economic impact report:
The rule change will result in less reporting for small business pharmacies, which currently must report any theft or loss to the local police, in addition to the United States Drug Enforcement Administration and the Wisconsin Pharmacy Examining Board. The board's revision adopts the federal criteria for significant loss, places local police reporting within the pharmacist's discretion, and allows two weeks from the date of filing with the United States Drug Enforcement Administration for filing with the Wisconsin Pharmacy Examining Board.
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.
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 of Regulation and Licensing estimates that this rule will require staff time in the Division of Management Services. The total staff salary and fringe is estimated at $872.
Effect on small business:
These proposed rules will have no significant economic impact on 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.
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.
Place where comments are to be submitted and deadline for submission:
Comments may be submitted 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 July 3, 2006 to be included in the record of rule-making proceedings.
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
450.04 (3) (b), Stats., and interpreting s.
450.04 (3) (b), Stats., the Pharmacy Examining Board will hold a public hearing at the time and place indicated below to consider an order to repeal ss.
Phar 17.04 (3) and
(5); to amend Phar 17.04 (2) and (4) and 17.05 (2); and to create Phar 2.02 (1) (c), relating to a foreign graduate internship.
Hearing Date, Time and Location
Date: June 22, 2006
Time: 10:00 a.m.
Location: 1400 East Washington Avenue
(Enter at 55 North Dickinson Street)
Room 121A
Madison, Wisconsin
Appearances at the Hearing
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 the Department of Regulation and Licensing, Office of Legal Counsel, P.O. Box 8935, Madison, Wisconsin 53708. Written comments must be received by July 3, 2006, to be included in the record of rule-making proceedings.
Analysis prepared by the Department of Regulation and Licensing.
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 granting of licenses to applicants for licensure as a pharmacist who have completed an internship in the practice of pharmacy.
Related statute or rule: Current Wis. Admin. Code ss.
Phar 2.02,
17.04.
Plain language analysis: The Pharmacy Examining Board requires foreign pharmacy graduates to submit proof of completion of at least 1500 hours of supervised internship prior to advancing in the application process toward the granting of a pharmacy license. The hours must be verified by the department. Wisconsin pharmacy rules require a graduate of a foreign pharmacy school to apply for a license as a pharmacist prior to beginning the required internship. Foreign Pharmacy Graduate Education Committee (FPGEC) certification, including passage of the examination, is not currently required unless the applicant exceeds 2000 internship hours. The current foreign graduate internship rules could be improved to ensure hours are adequately tracked by interns and supervisors and filed timely and accurately with the department. The rules do not require that a supervisor be identified prior to beginning an internship, resulting in incomplete reporting and difficulty in tracking internship hours.
The two primary objectives of this proposed rule-making are to: 1) require passage of the FPGEC prior to accumulation of any internship hours; and 2) improve procedures concerning the reporting of internship hours by foreign pharmacy graduate applicants and their supervisors.
The proposed rules would require completion of the examination offered by the FPGEC and submission of a report to the department identifying the intern's supervisor prior to the start of a foreign graduate internship.
SECTION 1 adds the application requirement that a person intending to engage in a foreign graduate internship must submit evidence satisfactory to the board of having obtained certification by the FPGEC and the disclosure of the person's supervising pharmacist. Any change of a supervising pharmacist must also be disclosed to the board by filing an amendment to the application. SECTION 1 also adds the requirement that prior to performing duties as an intern or to receiving credit for hours participating in a foreign graduate internship a person must file an application with the board for original licensure and submit evidence satisfactory to the board of having obtained certification by the FPGEC.
SECTION 2 adds the requirement that prior to performing duties as an intern or receiving credit for hours in an internship in the practice of pharmacy a supervising pharmacist shall be disclosed in the initial application and any change of a supervising pharmacist shall be disclosed to the board prior to further performing duties constituting the practice of pharmacy as an intern.
SECTION 3 repeals a provision allowing 2000 hours of practice as a pharmacy intern prior to receiving certification by the FPGEC.
SECTION 4 reduces the number of hours that may be practiced in a foreign graduate internship.
SECTION 5 repeals a grandfather provision that is no longer applicable.
SECTION 6 removes a typographical error.
Summary of, and comparison with, existing or proposed federal regulation: There is no existing or proposed federal regulation for summary and comparison.
Comparison with rules in adjacent states:
Iowa
Requires 1500 hours of internship. Foreign Pharmacy Graduate Examination Committee (FPGEC) certification required prior to internship credit being granted.
Illinois
Requires a minimum of 400 hours of internship. The applicant must obtain prior approval of the Board before enrolling in a course of clinical instruction.
Michigan
Requires a minimum of 1000 hours of internship and Foreign Pharmacy Graduate Examination Committee (FPGEC) certification required prior to internship license being granted, which is valid for a period of two years.
