Rule-making notices
Notice of Hearing
Elections Board
NOTICE IS HEREBY GIVEN that pursuant to ss.
5.05 (1) (f) and
227.11 (2) (a), Stats., and interpreting ss.11.01 (1), (6), (15), (16), 11.05 (1), (7), 11.06 (1), (3), (4), (12), 11.07, 11.10 (4), 11.24 (2), 11.26 (4), (10), 11.38 (1), Stats., the State Elections Board will hold a public hearing on the adoption of the rule proposed in this notice on Wednesday,
May 18, 2005, beginning at 9:30 a.m., at the Brookfield City Hall, Common Council Chambers, located at 2000 North Calhoun Road, in the City of Brookfield, Wisconsin, on the 18
th of May, 2005, at 9:30 a.m., to consider amendment of rule s. ElBd 1.39, relating to use of federal campaign funds in a campaign for a Wisconsin elective office.
Analysis Prepared by State Elections Board
Statutory authority: ss.5.05 (1) (f) and 227.11 (2) (a)
Statutes interpreted: ss.11.01 (1), (6), (15), (16), 11.05 (1), (7), 11.06 (1), (3), (4), (12), 11.07, 11.10 (4), 11.24 (2), 11.26 (4), (10), 11.38 (1), Stats.
This amended rule interprets ss.11.01(1), (6), (15), (16), 11.05 (1), (7), 11.06 (1), (3), (4), (12), 11.07, 11.10 (4), 11.24 (2), 11.26 (4), (10), 11.38 (1), Stats. The rule prohibits the conversion of federal campaign committees into state campaign committees and limits the contributions from federal campaign committees to state campaign committees to the maximum contribution allowable from a single committee to a candidate for the office sought.
Since the Bi-Partisan Campaign Reform Act of 2002, (BICRA), transfers of funds from a federal campaign committee to a state campaign committee had not been authorized under federal law. In November, 2004, Congress amended the Federal Election Campaign Act, (H.R. 4818, s. 532 (3) and 532 (4), to permit the transfer of a federal candidate's campaign committee's funds to the candidate's state campaign committee, if state law permitted, and subject to the state law's requirements and restrictions.
Because of Congress' action in November, 2004, money which had not been available to a state committee under BICRA, and which might not have qualified for use for political purposes in a state campaign because of its source or because of other noncompliance with state law, could now be transferred to a state committee, if state law permitted. Wisconsin law, under the Board's current rule, s. ElBd 1.39, Wis. Adm. Code, allows for conversion of federal campaign committees, and their funds, to a state campaign committee without regard to the source of those funds and without regard to contribution limitations. Prohibiting conversions and restricting such transfers to the maximum permissible for any other single committee to a candidate for the same office is found to be in the public interest.
Pursuant to the authority vested in the State of Wisconsin Elections Board by ss.
5.05 (1) (f) and
227.(11) (2) (a), Stats., the Elections Board proposes to amend s. ElBd 1.39 interpreting ss.
11.01 (1),
(6),
(15),
(16),
11.05 (1),
(7),
11.06 (1),
(3),
(4),
(12),
11.07,
11.10 (4),
11.24 (2),
11.26 (4),
(10),
11.38 (1), Stats., as follows:
SECTION 1. ElBd 1.39 is amended to read:
ElBd 1.39 Conversion of federal campaign committee to state committee prohibited.
(2) A
candidate's federal campaign committee may
not convert to a state campaign committee
and but may use funds collected for federal purposes in
the candidate's
a state or local campaign
, not to exceed the maximum amount that may be contributed by a single committee to a candidate for the same office, by filing a campaign finance registration statement, pursuant to s.
11.05, Stats., with the appropriate filing officer and simultaneously filing a campaign finance disclosure report showing the sources of all funds
on hand being contributed at the time of the report, pursuant to the requirements of s.
11.06 (1) (a),
(b),
(c),
(d) and
(f), Stats. In determining the sources of funds
on hand being contributed and allocating those funds among the sources, the funds shall be treated on a last-in, last-out basis, so that they will be attributed in the report to the most recent sources, in the full amount received from each source.
Initial Regulatory Flexibility Analysis
The creation of this rule does not affect business.
Fiscal Estimate
The creation of this rule has no fiscal effect.
Contact Person
George A. Dunst
Legal Counsel, State Elections Board
17 West Main Street, P.O. Box 2973
Madison, Wisconsin 53701-2973
Phone 266-0136
Notice of Hearing
Insurance
Notice is hereby given that pursuant to the authority granted under s.
601.41 (3), Stats., and the procedures set forth in under s.
227.18, Stats., OCI will hold a public hearing to consider the adoption of the attached proposed rulemaking order affecting Sections
Ins 17.01 (3) and
17.28 (6), Wis. Adm. Code, relating to annual injured patients and families compensation fund fees for fiscal year beginning July 1, 2005.
Hearing Information
Date: Thursday, May 19, 2005
Time: 10:00 a.m.
or as soon thereafter as the matter may be reached
Place: OCI, Room 223
125 South Webster St 2nd Floor
Madison, WI
Written comments or comments submitted through the Wisconsin Administrative Rule website at:
https://adminrules.wisconsin.gov on the proposed rule will be considered. The deadline for submitting comments is 4:00 p.m. on the day after the date for the hearing stated in this Notice of Hearing.
Written comments should be sent to:
Alice M. Shuman-Johnson
Legal Unit - OCI Rule Comment for Rule Ins 17285 PCF fee rule
Office of the Commissioner of Insurance
PO Box 7873
Madison WI 53707-7873
Summary of Proposed Rule & Fiscal Estimate
For a summary of the rule see the analysis contained in the attached proposed rulemaking order. There will be no state or local government fiscal effect. The full text of the proposed changes, a summary of the changes and the fiscal estimate are attached to this Notice of Hearing.
Analysis Prepared by the Office of the Commissioner of Insurance (OCI)
Explanation of the OCI's authority to promulgate the proposed rule under these statutes: The commissioner of insurance, with the approval of the board of governors (board) of the injured patients and families compensation fund (fund), is required to establish by administrative rule the annual fees which participating health care providers must pay to the fund.
Related Statutes or rules: None.
The plain language analysis and summary of the proposed rule: This rule establishes the fees which participating health care providers must pay to the fund for the fiscal year beginning July 1, 2005. These fees represent a 30 % decrease compared with fees paid for the 2004-05 fiscal year. The board approved these fees at its meeting on February 23, 2005, based on the recommendation of the board's actuarial and underwriting committee and reports of the fund's actuaries.
The board is also required to promulgate by rule the annual fees for the operation of the injured patients and families compensation mediation system, based on the recommendation of the director of state courts. This rule implements the funding level recommendation of the board's actuarial and underwriting committee by establishing mediation panel fees for the next fiscal year at $34.00 for physicians and $2.00 per occupied bed for hospitals, representing an decrease from 2004-05 fiscal year mediation panel fees.
Summary of and preliminary comparison with any existing or proposed federal regulation that is intended to address the activities to be regulated by the proposed rule: To the fund board's and OCI's knowledge there is no existing or proposed federal regulation that is intended to address patient compensation fund rates, administration or activities.
Comparison of similar rules in adjacent states as found by OCI: To the fund board's and OCI's knowledge there are no similar rules in the adjacent states to compare this rule to as none of these states have a patients compensation fund created by statute where rates are directed to be established yearly by rule as is true in Wisconsin.
A summary of the factual data and analytical methodologies that OCI used in support of the proposed rule and how any related findings support the regulatory approach chosen for the proposed rule: None. This rule establishes annual fund fees pursuant to the requirements of the above-noted Wisconsin statutes—no new regulatory approach is involved.
Any analysis and supporting documentation that OCI used in support of OCI's determination of the rule's effect on small businesses under s.
227.114: None. Fund fees are being
decreased in this rule.
If these changes may have a significant fiscal effect on the private sector, the anticipated costs that will be incurred by private sector in complying with the rule: This rule change will have no significant effect on the private sector.
A description of the Effect on Small Business: This rule will have little or no effect on small businesses.
Agency contact person: A copy of the full text of the proposed rule changes, analysis and fiscal estimate may be obtained from the WEB sites at:
http://oci.wi.gov/ocirules.htm or by contacting Inger Williams, OCI Services Section, at:
Phone: (608) 264-8110
Address: 125 South Webster St – 2nd Floor
Madison WI 53702
Mail: PO Box 7873
Madison WI 53707-7873
Place where comments are to be submitted and deadline for submission: The deadline for submitting comments is 4:00 p.m. on the day after the date for the hearing stated in the Notice of Hearing.
Mailing address
Alice M. Shuman-Johnson
Legal Unit - OCI Rule Comment for Rule Ins 17285 PCF fee rule
Office of the Commissioner of Insurance
PO Box 7873
Madison WI 53707-7873
Street address:
Alice M. Shuman-Johnson
Legal Unit - OCI Rule Comment for Rule Ins 17285 PCF fee rule
Office of the Commissioner of Insurance
125 South Webster St – 2nd Floor
Madison WI 53702
Initial Regulatory Flexibility Analysis
This rule does not impose any additional requirements on small businesses.
OCI Small Business Regulatory Coordinator
The OCI small business coordinator is Eileen Mallow and may be reached at phone number (608) 266- 7843 or at email address
Eileen.Mallow@oci.state.wi.us
Contact Person
A copy of the full text of the proposed rule changes, analysis and fiscal estimate may be obtained from the OCI internet WEB site at
http://oci.wi.gov/ocirules.htm or by contacting Inger Williams, Services Section, OCI, at:
Inger.Williams@OCI.State.WI.US, (608) 264-8110, 125 South Webster Street – 2
nd Floor, Madison WI or PO Box 7873, Madison WI 53707-7873.
Notice of Hearing
Natural Resources
(Fish, Game, etc., Chs.
NR 1—)
NOTICE IS HEREBY GIVEN that pursuant to ss.
29.014,
29.024 (5),
29.885 (2),
29.889 (2),
169.02,
169.15 (5),
169.19 (6),
169.25 (6) and
227.11, Stats., interpreting ss.
29.014,
29.024 (5),
29.885 (2),
29.889 (2),
169.02,
169.15 (5),
169.19 (6),
169.20 (4) and
169.25 (6), Stats., the Department of Natural Resources will hold a public hearing on revisions to chs.
NR 10,
12,
16,
17 and
19, Wis. Adm. Code, relating to permitting and applications, hunting, trapping, captive wildlife, agricultural damage and nuisance wildlife. These rule changes are minor in nature and non-controversial. The Department is proposing changes that clarify current rules, update definitions, increase management efficiency and alter limitations on hunters. This rule:
• Clarifies that cylinder loading black powder handguns may be used for hunting species other than deer or bear
•
Clarifies that doves are included under the definition of migratory game birds
•
Clarifies that a waterfowl blind also must be partially concealed when waterfowl hunting
• Creates a definition for rifle
•
Clarifies that hen pheasants held under ch.
29 or
169, Stats., authority are not considered protected
•
Clarifies that those unprotected species identified in ch.
169, Stats., may be taken live from the wild
•
Codifies the department position that pigeons are not considered wild animals
•
Clarifies that air guns may not be used for deer or bear hunting
•
Updates references to the submission of special permit applications necessary due to modified hours of operation for service centers
•
Codifies the issuance of special permits for those who incorrectly tag a deer
•
Clarifies that a structure, for the purposes of dry land body gripping type traps, is a single unit or structure
•
Updates rule language pertaining to use of cable restraints
•
Clarifies rules pertaining to turkey tagging and tag validation
•
Clarifies wildlife damage program regulations
NOTICE IS HEREBY FURTHER GIVEN that pursuant to s.
227.114, Stats., it is not anticipated that the proposed rule will have an economic impact on small businesses. The Department's Small Business Regulatory Coordinator may be reached at
SmallBusinessReg.Coordinator@dnr.state.wi.us or by calling (608) 266-1959.
NOTICE IS HEREBY FURTHER GIVEN that the Department has made a preliminary determination that this action does not involve significant adverse environmental effects and does not need an environmental analysis under ch.
NR 150, Wis. Adm. Code. However, based on the comments received, the Department may prepare an environmental analysis before proceeding with the proposal. This environmental review document would summarize the Department's consideration of the impacts of the proposal and reasonable alternatives.
NOTICE IS HEREBY FURTHER GIVEN that the hearing will be held on:
May 17, 2005 Room 511, GEF #2
Tuesday 101 South Webster Street, Madison
at 1:00 p.m.
NOTICE IS HEREBY FURTHER GIVEN that pursuant to the Americans with Disabilities Act, reasonable accommodations, including the provision of information material in an alternative format, will be provided for qualified individuals with disabilities upon request. Please call Kurt Thiede at (608) 267-2452 with specific information on your request at least 10 days before the date of the scheduled hearing.
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. Kurt Thiede, Bureau of Wildlife Management, P.O. Box 7921, Madison, WI 53707. Comments may be submitted until May 20, 2005. 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 Mr. Thiede.
Notice of Hearing
Natural Resources
(Fish, Game, etc., Chs.
NR 1—)
NOTICE IS HEREBY GIVEN that pursuant to ss.
77.06 (2),
77.91 (1) and
227.11 (2) (a), Stats., interpreting ss.
77.06 (2) and
77.91 (1), Stats., the Department of Natural Resources will hold a public hearing on the repeal and recreation of s.
NR 46.30 (2) (a) to
(c), Wis. Adm. Code, relating to the administration of the Forest Crop Law and Managed Forest Law. Sections
77.06 (2) and
77.91, Stats., require that the Department establish stumpage rates (values) used in calculating severance and yield taxes on timber harvested from land enrolled in the Forest Crop Law (FCL) and the Managed Forest Law (MCL). This rule would repeal and recreate s.
NR 46.30 (2) (a) to
(c) to revise the stumpage values to be used in calculating severance taxes and yield taxes for timber harvested during the period of November 1, 2005 and October 31, 2006. Thirteen separate zones reflect varying stumpage values for different species and products across the state. The average change for sawtimber is a 0.6% increase over current rates. The pulpwood prices, on average, would decrease 0.06%.
NOTICE IS HEREBY FURTHER GIVEN that pursuant to s.
227.114, Stats., the proposed rule may have an impact on small businesses. The initial regulatory flexibility analysis is as follows:
a. Types of small businesses affected: Small private forest landowners and forest industries enrolled under the Forest Crop Law and Managed Forest Law
b. Description of reporting and bookkeeping procedures required: No new procedures
c. Description of professional skills required: No new skills
The Department's Small Business Regulatory Coordinator may be contacted at SmallBusinessReg.Coordinator@dnr. state.wi.us or by calling (608) 266-1959.
NOTICE IS HEREBY FURTHER GIVEN that the Department has made a preliminary determination that this action does not involve significant adverse environmental effects and does not need an environmental analysis under ch.
NR 150, Wis. Adm. Code. However, based on the comments received, the Department may prepare an environmental analysis before proceeding with the proposal. This environmental review document would summarize the Department's consideration of the impacts of the proposal and reasonable alternatives.
NOTICE IS HEREBY FURTHER GIVEN that the hearing will be held on:
May 12, 2005 Wausau Service Center
Thursday 5301 Rib Mountain Drive, Wausau
at 10:00 a.m.
NOTICE IS HEREBY FURTHER GIVEN that pursuant to the Americans with Disabilities Act, reasonable accommodations, including the provision of information material in an alternative format, will be provided for qualified individuals with disabilities upon request. Please call Carol Nielsen at (608) 266-8019 with specific information on your request at least 10 days before the date of the scheduled hearing.
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 Ms. Carol Nielsen, Bureau of Forestry, P.O. Box 7921, Madison, WI 53707. Comments may be submitted until May 13, 2005. 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 Ms. Nielsen.
Notice of Hearing
Natural Resources
(Environmental Protection—Water Regulation, Chs.
NR 300—)
NOTICE IS HEREBY GIVEN that pursuant to ss.
30.12 (1) and
(1p),
30.2035,
30.206,
227.11 (2) and
227.24, Stats., interpreting ss.
30.12 (1),
(1g),
(3) and
(3m) and
30.206, Stats., the Department of Natural Resources will hold a public hearing on Natural Resources Board Emergency Order No. FH-16-05(E) pertaining to the creation of ch.
NR 328, subch. III, Wis. Adm. Code, relating to shore erosion control on rivers and streams. This emergency order takes effect on May 1, 2005.
The purpose of this emergency order is to establish two general permits with appropriate conditions, and to establish standards for projects that may be authorized under an individual permit. There are no statutory exemptions for the placement of shore erosion control on the banks of rivers and streams. Standards for general permits and individual permits in this section are based on the science of fluvial geomorphology for determining erosive conditions at a site. Fluvial geomorphology involves studying the influence of flowing surface water on stream channels through the processes of erosion and deposition. This order establishes general permits for biological erosion control and integrated bank protection on waterways less than 35 feet wide and allows placement of these structures in “areas of special natural resource interest".
The Department's Small Business Regulatory Coordinator may be contacted at SmallBusinessReg.Coordinator@ dnr.state.wi.us or by calling (608) 266-1959.
NOTICE IS HEREBY FURTHER GIVEN that the hearing will be held on:
May 16, 2005 Room 413, GEF #2
Monday 101 South Webster Street, Madison
at 1:00 p.m.
NOTICE IS HEREBY FURTHER GIVEN that pursuant to the Americans with Disabilities Act, reasonable accommodations, including the provision of information material in an alternative format, will be provided for qualified individuals with disabilities upon request. Please call Liesa Lehmann at (608) 266-2997 with specific information on your request at least 10 days before the date of the scheduled hearing.
The emergency rule and fiscal estimate may be reviewed and at the following Internet site: adminrules.wisconsin.gov. Written comments on the rule may be submitted via U.S. Mail to Ms. Mary Ellen Vollbrecht, Bureau of Fisheries Management and Habitat Protection, P.O. Box 7921, Madison, WI 53707. Comments may be submitted until May 27, 2005. Written comments 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 Ms. Lehmann.
Notice of Hearing
Natural Resources
(Environmental Protection)
NOTICE IS HEREBY GIVEN that pursuant to ss.
289.05,
289.06,
289.21,
289.24,
289.30,
289.31,
289.33,
289.41,
289.43,
289.61,
289.63,
291.05,
291.07,
291.25,
299.53,
227.11 (2) (a) and
227.14 (1m), Stats., and interpreting Sections
227.14 (1m),
289.06,
289.24,
289.30,
289.41,
289.46 and
289.67, Stats., ch.
291, Stats., and s.
299.53, Stats., the Department of Natural Resources will hold public hearings on proposed Natural Resources Board Order No. WA-10-05 to repeal and recreate chs.
NR 590 and
NR 600 to
690, Wis. Adm. Code, regulating the generation, transportation, recycling, treatment, storage and disposal of used oil, universal waste and hazardous waste.
The proposed rules define the types of materials that are regulated as hazardous waste, universal waste and used oil. The rules describe the standards that apply to anyone who generates, transports or recycles these wastes, as well as to the facilities that treat, store and dispose of the wastes. Generators of hazardous waste are subject to a varying degree of regulation depending on the amounts and types of waste generated. Hazardous waste transporters are subject to licensing requirements and operating standards. Owners and operators of hazardous waste treatment, storage or disposal facilities are subject to licensing requirements that include department review and approval, and input from the public before receiving a license to operate the facilities. Recyclers of hazardous waste are conditionally exempt from most of the facility licensing requirements to encourage the recycling and reuse of hazardous waste that would otherwise be sent for disposal.
The proposed rules increase the hazardous waste plan review, license and manifest fees. The majority of the proposed fee increases represent about a 3% increase per year since 1994 to account for inflation, although some proposed fees represent a higher percentage increase and some fees are decreasing or being eliminated. In addition, the proposed rules create a per vehicle fee for vehicles under a Hazardous Waste Transportation Service License and increase the manifest fee from $2 to $6 per manifest.
The format for the proposed rules is similar to the federal regulations published in the code of federal regulations by U.S. Environmental Protection Agency (EPA). The proposed revisions incorporate updates based on federal rules that are already in effect. These revisions include provisions to facilitate legitimate recycling, paperwork reduction for business and flexibility in design and operation of hazardous waste management facilities. Some revisions are necessary to retain authorization from EPA to implement the federal hazardous waste program in Wisconsin.
NOTICE IS HEREBY FURTHER GIVEN that pursuant to s.
227.114, Stats., the proposed rules may have a direct impact on small businesses.
Initial Regulatory Flexibility Analysis
1. Describe the type of small business that will be affected by the rule. Small businesses that generate or transport hazardous waste will be affected by the proposed rules. The proposed rules reduce regulation in several areas, including reductions in paperwork and also provide conditional exemptions from the rules for businesses that legitimately recycle their wastes. Examples of the types of small businesses that could be affected by the rules are dry cleaners, automotive repair shops, printing companies that use certain solvent based inks or cleaners, and metal finishing companies, which includes electroplaters.
2. Briefly explain the reporting, bookkeeping and other procedures required for compliance with the rule. Under both the current and proposed rules, entities that generate very small quantities of hazardous waste (less than 220 pounds per month) are exempt from most of the hazardous waste requirements. They must comply with the management standards for the safe storage of wastes in containers and tanks and properly recycle or dispose of wastes. For recordkeeping, very small quantity generators are only required to submit copies of final, signed manifests for hazardous waste shipped to out-of-state treatment, storage or disposal facilities, and keep final copies of the manifests for three years if the generator uses a manifest (the use of a manifest is not required). Additional recordkeeping requirements for businesses that are considered small quantity hazardous waste generators (220 to 2200 pounds per month) include submitting annual reports to the department. The reports summarize the amounts and types of waste generated, and how the waste was managed. These reports are significantly reduced in scope as compared to the reporting requirements for large quantity generators. There are also fewer administrative requirements for small generators than large generators. Examples are reduced requirements for employee training, and preparedness and prevention for emergency situations.
3. Describe the type of professional skills necessary for compliance with the rule. There are no special professional skills necessary to comply with the rules. No new skills are required to comply with the rules. Familiarity with computers and access to the Internet are helpful, but not essential. The rules are available from the Revisor, in print and on the department's web page. Guidance documents on a number of related topics are available on the department's web page, and staff in the DNR regional offices are available to provide assistance and answer questions.
NOTICE IS HEREBY FURTHER GIVEN that the Department has made a preliminary determination that this action does not involve significant adverse environmental effects and does not need an environmental analysis under ch.
NR 150, Wis. Adm. Code. However, based on the comments received, the Department may prepare an environmental analysis before proceeding with the proposal. This environmental review document would summarize the Department's consideration of the impacts of the proposal and reasonable alternatives.
NOTICE IS HEREBY FURTHER GIVEN that four public hearings will be held on:
Wednesday, May 11, 2005 at 9:00 a.m.
Room 413
WI Dept. of Natural Resources
101 South Webster Street
Madison
Thursday, May 12, 2005 at 2:30 p.m.
Video conference participation available at:
Room 139, State Office Building
718 W. Clairemont Ave.
Eau Claire
Room 220, Main Building
UW-Marathon Center
518 S. 7th Ave.
Wausau
Friday, May 13, 2005 at 9:00 a.m.
Room 151, State Office Building
141 NW Barstow Street
Waukesha
NOTICE IS HEREBY FURTHER GIVEN that pursuant to the Americans with Disabilities Act, reasonable accommodations, including the provisions of informational materials in an alternative format, will be provided for qualified individuals with disabilities upon request. Please call Ms. Pat Chabot at (608) 264-6015 with specific information on your request at least 10 days before the date of the scheduled hearing.
The proposed rules may be reviewed and comments electronically submitted at the following Internet site:
http://adminrules.wisconsin.gov. Electronic comments must be entered into the Administrative Rules System by May 30, 2005. Written comments on the proposed administrative rules may be submitted via U.S. Mail to Ms. Pat Chabot - WA/3, Bureau of Waste Management, P. O. Box 7921, Madison, WI 53707-7921. To be considered, written comments must be postmarked or received by 4:30 p.m. on May 30, 2005. Written and electronic comments will have the same weight and effect as oral statements presented at the hearings. Copies of the proposed rules and fiscal estimate may be obtained from Ms. Chabot.
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), Wis. Stats., and interpreting s.
450.09 (7m), Wis. Stats., the Pharmacy Examining Board will hold a public hearing at the time and place indicated below to consider an order to amend Phar 7.04 (2) (intro.) and (b); and to create Phar 7.04 (1) (c) to (f), (2) (d) and (e), (3m), (5), and two Notes following Phar 7.04 (5), relating to the return of exchange of health items.
Hearing Date, Time and Location
Date: June 22, 2005
Time: 9:30 A.M.
Location: 1400 East Washington Avenue
Room 179A
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, 1400 East Washington Avenue, Room 171, P.O. Box 8935, Madison, Wisconsin 53708. Comments must be received on or before July 6, 2005, 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 security standards for pharmacies, enforcing chapters 450 and 961, Stats, and establishing minimum standards for the practice of pharmacy and the dispensing of drugs. The return or exchange of health items is addressed specifically in the instance of state prisons, s.
450.09 (7m), Stats. The board also regulates this area of pharmacy practice in the non-state prison context in s.
Phar 7.04.
Related statute or rule: Cancer drug returns and redispensing are allowed provided the pharmacy follows the requirements in proposed ch.
HFS 148, which has not become final.
Plain language analysis: The Pharmacy Examining Board is amending the requirements of s.
Phar 7.04, pertaining to the return or exchange of health items, to allow for their return or exchange from community-based residential facilities (CBRFs), jails, and juvenile secured facilities. The amended rules set forth those circumstances under which a return or exchange of health items is allowed.
SECTION 1 adds new definitions for “original container," “resident health care patient," “secured institutional health care patient," and “tamper-resistant package."
SECTION 2 clarifies that health item returns may only be made to the pharmacy that dispensed them, and substitutes the term “beyond use date" for “expiration."
SECTION 3 lists the requirements for when health items may be returned to a pharmacy that dispensed them for the purpose of redispensing. The rule allows returns and redispensing of health items from secured institutional or resident health care patients, and for prepackaged non-narcotic, non-prescription drugs from any patient. Secured institutional patients include both jail inmates subject to the Department of Corrections approved policy and procedures manual for the control and administration of medications and juvenile patients residing in certain secured institutions whose health items are maintained by Department of Corrections staff.
For returns of health items from secured institutional health care patients, the rules also require those items to be segregated and prohibits the pharmacy from redispensing those items other than to a secured institutional health care patient.
Exempted from the definition of a “return" is the delivery to a pharmacy of a drug or device that was previously dispensed if the purpose of the delivery is for destruction at the pharmacy or by another authorized person or entity.
Also added are two notes referring to cancer drug returns and state prison pharmacy returns, which are governed by different statutory and rule authority.
Summary of, and comparison with, existing or proposed federal regulation: 21 U.S.C. § 360 (g) (1) (registration and manufacturers) provides: The foregoing subsections of this section shall not apply to-
(1) pharmacies which maintain establishments in conformance with any applicable local laws regulating the practice of pharmacy and medicine and which are regularly engaged in dispensing prescription drugs or devices, upon prescriptions of practitioners licensed to administer such drugs or devices to patients under the care of such practitioners in the course of their professional practice, and which do not manufacture, prepare, propagate, compound, or process drugs or devices for sale other than in the regular course of their business of dispensing or selling drugs or devices at retail; (emphasis added)
2. Section 374(a)(2)(A) (inspection) (the Exemption) provides:
(2) The provisions of the third sentence of paragraph (1) shall not apply to-
(A) pharmacies which maintain establishments in conformance with any applicable local laws regulating the practice of pharmacy and medicine and which are regularly engaged in dispensing prescription drugs or devices, upon prescriptions of practitioners licensed to administer such drugs or devices to patients under the care of such practitioners in the course of their professional practice, and which do not, either through a subsidiary or otherwise, manufacture, prepare, propagate, compound, or process drugs or devices for sale other than in the regular course of their business of dispensing or selling drugs or devices at retail; (emphasis added)
3. The Drug Enforcement Agency does not permit the return of controlled substances from non DEA registrants.
Comparison with rules in adjacent states
Minnesota
6800.2700 RETURN OF DRUGS AND DEVICES.
Subpart 1. Reuse. Pharmacists and pharmacies are prohibited from accepting from patients or their agents for reuse, reissue, or resale any drugs, prescribed medications, chemicals, poisons, or medical devices; except that in a hospital with a licensed pharmacy, drugs, devices, or other items dispensed for hospital inpatient use may be returned to the pharmacy for disposition by a pharmacist in accordance with good professional practice.
Subp. 2. Drugs from nursing homes. Drugs from nursing homes may be returned to the dispensing pharmacy if:
A. the consultant pharmacist can assure proper storage conditions for the drugs in the facility as specified in the United States Pharmacopeia, (United States Pharmacopeial Convention, Inc., Rockville, Maryland);
B. the drugs are returned to the pharmacy which dispensed the drugs;
C. the integrity of such packaging remains intact (no reconstituted drugs, drugs requiring refrigeration, or controlled substances may be so returned); and
D. the drugs are received by the pharmacy in the original manufacturer's packaging or pharmacist packager's unit-dose, unit-of-use, or strip packaging with each tablet or capsule individually wrapped and labeled, or in blister cards, which indicate the drug name and strength, the packager's name, and the manufacturer's or packager's lot or batch number. Drugs packaged by a pharmacy may be returned only if the pharmacy can demonstrate to the board that its packaging material and procedures will provide a package that will meet or exceed the criteria for class B packaging established by the United States Pharmacopeia, (United States Pharmacopeial Convention, Inc., Rockville, Maryland), and that procedures have been developed and implemented to prevent the commingling of dosage units of different lot numbers.
Subp. 3. Commingling. Commingling of returned medication or mixing of lot numbers of returned medication, upon or prior to repackaging, shall result in such medication being deemed misbranded and subject to embargo under Minnesota Statutes, section 151.38. This prohibition shall not apply to the return of medical devices provided that proper sanitary procedures are used prior to the reuse, resale, or rerent thereof.
HIST: 18 SR 1145
Current as of 10/27/03
Illinois:
Section 1330.91 Division I Pharmacies
a) Retail pharmacies which engage in general community pharmacy practice and are open to, or offer pharmacy service to, the general public shall, in addition to any other requirements of the Act and this Part, comply with Section 1330.91. A retail pharmacy which, in addition to offering pharmacy services to the general public, provides pharmacy services to an institution or facility listed in Sections 1330.92 (a) need not register as a Division II pharmacy if the sales do not exceed 49% of total sales, but the pharmacy shall comply with requirements of Sections 1330.92 (b), (c) and (d).
f) Pharmacists and pharmacies are prohibited from accepting from patients or their agents for reuse, reissue or resale any dispensed medications, chemicals, poisons or medical devices except for:
1) Medical devices which can be properly sanitized prior to reuse, resale or rerent; and
2) Medications and medical devices that are dispensed and stored under conditions defined and supervised by the pharmacist and are unopened in sealed, intact and unaltered containers that meet the standards for light, moisture and air permeation as defined by the current United States Pharmacopoeia (U.S.P.)/National Formulary or by the United States Pharmacopeial Convention, Inc.
Section 1330.92 Division II Pharmacies
a) Pharmacies which are not located in the facilities they serve and whose primary service is to provide services to patients or residents of facilities licensed under the Nursing Home Care Reform Act of 1979 or the Hospital Licensing Act, or the University of Illinois Hospital Act shall, in addition to any other requirements of the Act and this Part, comply with this Section.
f) Pharmacists and pharmacies are prohibited from accepting from patients or their agents for reuse, reissue or resale any dispensed medications, chemicals, poisons or medical devices except for:
1) Medical devices which can be properly sanitized prior to reuse, resale or rerent; and
2) Medications and medical devices that are dispensed and stored under conditions defined and supervised by the pharmacist and are unopened in sealed, intact and unaltered containers that meet the standards for light, moisture and air permeation as defined by the current United States Pharmacopoeia (U.S.P.)/National Formulary or by the United States Pharmacopoeial Convention, Inc.
Section 1330.93 Division III Pharmacies
a) Pharmacies which are located in facilities licensed under the Nursing Home Care Reform Act of 1979, the Hospital Licensing Act, or the University of Illinois Hospital Act, or are operated by the Department of Human Services or the Department of Corrections, and which provide pharmacy services to residents, patients, employees, prescribers and students of these facilities, shall, in addition to other requirements of the Act and this Part, comply with this Section.
d) Staffing of the Pharmacy
8) Pharmacists and pharmacies are prohibited from accepting from patients or their agents for reuse, or resale dispensed medications, chemicals, poisons or medical devices except for:
A) Medical devices which can be properly sanitized prior to reuse, resale or rerent; and
B) Medications that are dispensed and stored under conditions defined and supervised by the pharmacist and are unopened in sealed, intact and unaltered containers that meet the standards for light, moisture and air permeation as defined by a current United States Pharmacopoeia/National Formulary published by the United States Pharmacopoeial Convention, Inc.
Section 1330.94 Division IV Pharmacies
a) Pharmacies which provide and/or offer for sale radiopharmaceuticals shall in addition to any other requirements of the Act and this Part comply with this Section 1330.94.
(NONE)
Section 1330.95 Division V Pharmacies
a) Pharmacies Required to Hold Division V Licenses
1) Pharmacies which are located in or provide service to ambulatory care facilities, schools of veterinary medicine or other institutions or facilities. In addition to other requirements of the Act and this Part, these pharmacies shall comply with this Section.
2) Pharmacies that hold Division II licenses and provide pharmacy services to the general public. In addition to other requirements of the Act and Rules, these pharmacies shall comply with Section 1330.92 and this Section.
3) Pharmacies that hold Division III licenses and provide pharmacy services to the general public. In addition to other requirements of the Act and Rules, these pharmacies shall comply with Section 1330.93 and this Section.
f) Pharmacists and pharmacies are prohibited from accepting from patients or their agents for reuse, or resale any dispensed medications, chemicals, poisons or medical devices except for:
1) Medical devices that can be properly sanitized prior to reuse, resale or rerent; and
2) Medications and medical devices that are dispensed and stored under conditions defined and supervised by the pharmacist and are unopened in sealed, intact and unaltered containers that meet the standards for light, moisture and air permeation as defined by the current United States Pharmacopoeia (U.S.P.)/National Formulary or by the United States Pharmacopoeial Convention, Inc.
IOWA:
657—6.15(124,126) Return of drugs and other items. For the protection of the public health and safety, prescription drugs and devices, controlled substances, and items of personal contact may be returned to the pharmacy for reuse or resale only as herein provided:
6.15(1) Integrity maintained. Prescription drugs and devices may be returned, exchanged, or resold only if, in the professional judgment of the pharmacist, the integrity of the prescription drug has not in any way been compromised.
6.15(2) Controlled substances. Under no circumstances shall pharmacy personnel accept from a patient or a patient's agent any controlled substances for return, exchange, or resale except to the same patient.
6.15(3) Noncontrolled substance returns. Prescription drugs, excluding controlled substances, may be returned and reused as authorized in 657—subrule 11.1(6).
6.15(4) Personal contact items. Pharmacy personnel shall not accept for reuse or resale any items of personal contact nature that have been removed from the original package or container after sale.
Indiana-returns
856 IAC 1-21 Resale of returned substances
Authority: IC 25-26-13-4
Affected: IC 25-26-13-25
Sec. 1. (a) This section implements and interprets IC 25-26-13-15(h) concerning the resale or redistribution of medications.
(b) For a medication to have been properly stored and securely maintained according to sound pharmacy practices, the storage and administration of medications in the institutional facility must be under the immediate control of licensed nursing personnel.
(c) If the medication was originally packaged by the dispensing pharmacy, it cannot be resold or redistributed unless:
(1) the medication has been repackaged into unit-dose packaging using packaging materials that meets Class A or Class B standards, found in the United States Pharmacopeia (U.S.P.), page 1574, published by the United States Pharmacopeia, 22nd Revision, January 1, 1990, United States Pharmacopeia Convention, Inc., 12601 Twinbrook Parkway, Rockville, Maryland 20852, which standards are incorporated herein by reference; and
(2) the repackaging process complies with the standards as found in the “Proper Treatment of Products Subjected to Additional Manipulations, Section 1191" of the United States Pharmacopeia, page 1705, 22nd Revision, 1990, which section is incorporated herein by reference.
(d) A medication repackaged under the provisions of subsection (c) shall be labeled with an expiration date of not greater than one (1) year until the manufacturer's expiration date, whichever is earlier. (Indiana Board of Pharmacy; Reg 21, Sec 1; filed Jun 18, 1962, 10:00 a.m.: Rules and Regs. 1963, p. 128; filed Mar 31, 1992, 5:00 p.m.: 15 IR 1391; readopted filed Dec 2, 2001, 12:35 p.m.: 25 IR 1334)
Michigan-returns
R 338.472 Prescription drugs and devices; returns or exchange for resale prohibited,
Rule 2. For the protection of the public health and safety, prescription drugs or devices which have been dispensed and which have left the control of the pharmacist shall not be returned or exchanged for resale.
Summary of factual data and analytical methodologies: In view of rising health care costs in general and the escalating cost of pharmaceuticals in particular, the Pharmacy Examining Board recognized the need to change its rules to allow for the return and redispensing of prescription drugs and devices that were previously destroyed. The board considered correspondence from policy makers and legislators, the experience of its own members, expertise provided by other state agencies, and legal counsel summarization of current rules and regulations that apply to resident health care patients and secured institutional health care patients, in addition to recent legislation governing the return of cancer drugs and drugs from patients in state prisons.
Determination of significant fiscal effect on the private sector: The department finds that this rule has no significant fiscal effect on the private sector.
Fiscal estimate
The proposed rule will have no impact on the department's funds.
Effect on small business: These proposed rules will have no significant economic impact on a substantial number of small businesses, as defined in s.
227.114 (1) (a), Stats. The Department's Regulatory Review Coordinator may be contacted by email at
christopher.klein@drl.state.wi.us, or by calling (608) 266-8608.
Agency contact person
Pamela Haack
Department of Regulation and Licensing
Office of Legal Counsel
1400 East Washington Avenue, Room 171
P.O. Box 8935
Madison, Wisconsin 53708-8935
Telephone: (608) 266-0495
Place where comments are to be submitted and deadline for submission
Comments may be submitted to Pamela Haack, Department of Regulation and Licensing, 1400 East Washington Avenue, Room 171, 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 6, 2005 to be included in the record of rule-making proceedings.
TEXT OF RULE
SECTION 1. Phar 7.04 (1) (c) to (f) are created to read:
Phar 7.04 (1) (c) “Original container" means the container in which a health item was sold, distributed or dispensed.
(d) “Resident health care patient" means a patient residing in a community-based residential facility that controls a resident's prescribed and over-the-counter medications as specified by s.
HFS 83.33 (3) (b) 2.
(e) “Secured institutional health care patient" means any of the following:
1. A jail inmate patient whose dispensed health items are maintained under the custody and control of the jail pursuant to an approved policy and procedure manual under s.
DOC 350.17, containing policies and procedures for the control and administration of medications complying with s.
DOC 350.20.
2. A juvenile patient who resides in a secured correctional facility, as defined in s.
938.02 (15m), Stats.; a secured child caring institution, as defined in s.
938.02 (15g), Stats.; a secured group home, as defined in s.
938.02 (15p), Stats.; a secured detention facility, as defined in s.
938.02 (16), Stats.; or a juvenile portion of a county jail whose dispensed health items are maintained under the custody and control of the health services staff as defined in s.
DOC 316.02 (6) and provided to a juvenile patient under the provisions of s.
DOC 316.03.
(f) “Tamper-resistant package" means a container that is sealed so that the contents cannot be used without obvious destruction of the seal.
SECTION 2. Phar 7.04 (2) (intro.) and (b) are amended to read:
Phar 7.04 (2) (intro.) No health items after taken from a pharmacy where sold, distributed or dispensed, may be returned to that pharmacy, except for any of the following:
(b) Where the health items were dispensed in error, were defective, adulterated, misbranded, or dispensed beyond their expiration beyond use date.
SECTION 3. Phar 7.04 (2) (d) and (e), (3m), (5) and two Notes following Phar 7.04 (5) are created to read:
Phar 7.04 (2) (d) For a secured institutional health care patient or resident health care patient where:
1. The health item was never in the possession and control of the patient.
2. The health item was sold, distributed or dispensed in a tamper-resistant package and for a drug includes the beyond use date and manufacturer's lot number.
3. The health item is not commingled with a different health item unless the health item will be repackaged and redispensed to the same patient.
4. The health item is in its original container and the pharmacist determines the contents are not adulterated or misbranded.
(e) A non-narcotic nonprescription drug that is prepackaged for consumer use and labeled in compliance with all applicable state and federal laws where:
1. The pharmacist determines that the original package is unopened, sealed and intact and that package labeling is unaltered.
2. In the professional judgment of the pharmacist the contents are not adulterated.
(3m) Health items returned from a secured institutional health care patient to a pharmacy pursuant to sub. (2) (d), must be segregated in the pharmacy and may not be sold, resold, or repackaged and sold or resold, given away, or otherwise sold, distributed or redispensed other than to a secured institutional health care patient.
(5) It is not a “return" for a patient or agent of a patient to deliver a previously dispensed drug or device to a pharmacy for the purpose of destruction at the pharmacy or other disposal by an authorized person or entity.
Note: Cancer drug returns and redispensing pursuant to ch.
HFS 148 are allowed provided the pharmacy follows the requirements in ch.
HFS 148.
Note: A prescription drug that is returned to a pharmacy that primarily serves patients confined in a state prison not addressed in this rule may be redispensed to a patient in a state prison provided the requirements of s.
450.09 (7m), Stats., are satisfied.
