Rule-making notices
Notice of Hearing
Pharmacy Examining Board
Hearing Date, Time and Location
Date: September 7, 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 September 19, 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 minimum standards for the practice of pharmacy. The practice of pharmacy includes creating and maintaining accurate records and the transfer of prescription order information.
Related statute or rule: Current Wis. Admin. Code s.
Phar 7.05
Plain language analysis: The purpose of the proposed rule change is to provide greater clarity to guide pharmacists to differentiate between requirements for prescription recordkeeping generally versus the transfer of prescription order information. The use of a computer system for both purposes has components in common, but contain differences and limitations. The interplay of federal law was also more explicitly recognized by listing the additional requirements for the transfer of prescription order information necessary to comply with federal law.
SECTION 1 renumbers a section of the current rule regarding the period of time that pharmacy records must be kept and amends the rule to create consistent language usage between federal and state administrative rules.
SECTION 2 repeals sections of the current rule regarding the transfer of prescription order information.
SECTION 3 renumbers a section of the current rule and amends the rule to create consistent language usage between federal and state administrative rules and to segregate the requirements for general pharmacy recordkeeping.
SECTION 4 creates a new section to specify the requirements for the transfer of prescription order information. The requirements are delineated into four separate subsections; general requirements, non-controlled substances, controlled substances and the use of a computer system. The general requirements subsection applies to all transfers of prescription order information performed either verbally or by the use of a computer system, including the requirement that a pharmacist making a transfer or receiving a transfer must be licensed in the state in which they perform an act required to accomplish the transfer. The requirements subsection for non-controlled substances specifically delineates the information that must be recorded by the transferring and receiving pharmacist. The requirements subsection for controlled substances adds additional requirements for information to be recorded that is required by federal law.
Summary of factual data and analytical methodologies: The Pharmacy Examining Board reviewed adjacent state rules and federal law to determine how the impact of technology was influencing the practice of transferring prescription order information. The board became aware that greater clarity was needed to provide practice guidance to pharmacists to differentiate between prescription recordkeeping generally versus the transfer of prescription order information which uses and creates records. The use of a computer system for both purposes had become clouded in the rule in its present form as the rule had been amended piecemeal during the course of past years. Therefore, the board chose to repeal and recreate part of the rule related to the transfer of prescription order information, and to separate and update the current rule relating to the use of computer systems to maintain records generally in a pharmacy.
Anticipated costs incurred by private sector: The department finds that this rule has no significant fiscal effect on the private sector.
Fiscal estimate
The proposed rule will have minimal impact on the department's funds. The department will expend some training time and resources to update inspectors on these recordkeeping requirements.
Effect on small business
These proposed rules will be reviewed by the department's small business review advisory committee to determine whether they will have a 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.
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. 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, 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 September 19, 2005 to be included in the record of rule-making proceedings.
TEXT OF RULE
SECTION 1. Phar 7.05 (1) is renumbered Phar 7.05 (1m) and as renumbered is amended to read:
Phar 7.05 (1m) A record of all prescriptions dispensed shall be maintained for a period of 5 years after the date of the last renewal refill.
SECTION 2. Phar 7.05 (3) to (5) and the Note following 7.05 (5) are repealed.
SECTION 3. Phar 7.05 (6) is renumbered Phar 7.05 (1) and as renumbered Phar 7.05 (1) (intro.) and (b) are amended to read:
Phar 7.05 (1) (intro.) A computerized system may be used for maintaining a record required of prescription dispensing and transfers of prescription order information for the purposes of original or renewal refill dispensing if the system:
(b) Is equipped with an auxiliary procedure which, during periods of down-time, shall be used for documentation of prescription dispensing. The auxiliary procedure shall ensure that prescription renewals refills are authorized by the original prescription order, that the maximum number of prescription renewals refills has not been exceeded and that all of the appropriate data are retained for on-line entry as soon as the computer system is again available for use.
SECTION 4. Phar 7.055 is created to read:
Phar 7.055 Transfer of prescription order information. (1) GENERAL REQUIREMENTS. The transfer of prescription order information for the purpose of original or refill dispensing is permissible between pharmacies licensed in this state or another state pursuant to the following general requirements:
(a) The transfer shall be communicated directly between 2 pharmacists either by verbal transfer or by a computer system transfer meeting the requirements of sub. (4). Communication by facsimile machine is not allowed unless the prescription order information being transferred is verified verbally between 2 pharmacists.
(b) If a verbal transfer of prescription order information is performed for a non-controlled substance, the pharmacist making the transfer may record the information required by sub. (2) on a computer system meeting the requirements of s.
Phar 7.05 (1) (a) and
(b).
(c) The pharmacist receiving the verbal transfer of prescription order information for either a controlled or a non-controlled substance shall record the transferred information in writing unless a computer system transfer meeting the requirements of sub. (4) is used.
(d) All original and transferred prescription orders shall be maintained for a period of 5 years from the date of the last refill.
(e) A written copy of any prescription order for a prescribed drug provided by a pharmacist shall be identified in writing as “COPY – FOR INFORMATION ONLY." No prescribed drug may be dispensed based on an information copy.
(f) A pharmacist making or receiving a transfer of prescription order information shall be licensed in the state in which they perform an act required by this section.
(2) NON-CONTROLLED SUBSTANCES. The transfer of prescription order information for non-controlled substances for the purposes of original or refill dispensing is permissible pursuant to the following requirements:
(a) The pharmacist making the transfer records the following information:
1. The word “VOID" is written on the face of the invalidated prescription order or recorded in a similar manner to “VOID" a prescription order in a computer system meeting the requirements of s.
Phar 7.05 (1) (a) and
(b).
2. The name and address of the pharmacy to which it was transferred, the name of the pharmacist receiving the prescription order, the date and the name of the pharmacist transferring the information are recorded on the reverse side of the invalidated prescription order or in a computer system meeting the requirements of s.
Phar 7.05 (1) (a) and
(b).
3. A transfer of prescription order information for a non-controlled substance for the purposes of refill dispensing is limited to the number of authorized refills.
(b) The pharmacist receiving the transferred prescription order information shall record in writing the following:
1. The word “TRANSFER" on the face of the transferred prescription order.
2. The name and address of the patient, the name and address of the prescribing practitioner, and the name and quantity and dosage form of the drug product or device prescribed and the directions for use.
3. The date of issuance of the original prescription order.
4. The original number of refills authorized on the original prescription order.
5. The date of original dispensing if the prescription order has previously been dispensed.
6. The number of valid refills remaining and the date of the last refill.
7. The pharmacy's name, address, and the prescription order number from which the prescription order information was transferred.
8. The name of the pharmacist making the transfer.
9. The name, address and telephone number of the pharmacy from which the original prescription order was transferred if different than subd. 7.
(3) CONTROLLED SUBSTANCES. The transfer of prescription order information for controlled substances for the purposes of refill dispensing is permissible pursuant to the following requirements:
(a) The transfer of prescription order information is permissible only on a one time basis unless a computer system meeting the requirements of sub. (4) is used.
(b) If a computer system meeting the requirements of sub. (4) is used a transfer of prescription order information for the purposes of refill dispensing is limited to the number of authorized refills.
(c) Unless a computer system meeting the requirements of sub. (4) is used the pharmacist making the transfer shall record in writing the following information:
1. The word “VOID" is written on the face of the invalidated prescription order.
2. The name, address and DEA registration number of the pharmacy to which it was transferred, the name of the pharmacist receiving the prescription order and the date and the name of the pharmacist transferring the information are recorded on the reverse side of the invalidated prescription order.
(d) Unless a computer system meeting the requirements of sub. (4) is used the pharmacist receiving the transferred prescription order information shall record in writing the following information:
1. The word “TRANSFER" on the face of the transferred prescription order.
2. The name and address of the patient, the name, address and DEA number of the prescribing practitioner, and the name and quantity and dosage form of the drug product or device prescribed and the directions for use.
3. The date of issuance of the original prescription order.
4. The original number of refills authorized on the original prescription order.
5. The date of original dispensing.
6. The number of valid refills remaining and the dates and locations of previous refills, if applicable.
7. The name, address, telephone number, DEA registration number and prescription order number of the pharmacy from which the prescription order information was transferred if different from the pharmacy from which the prescription order was originally dispensed.
8. The name of the pharmacist making the transfer.
9. The name, address, telephone number, DEA registration number and prescription order number of the pharmacy from which the prescription order was originally dispensed.
(4) USE OF COMPUTER SYSTEM. A computer system used for transferring prescription order information shall, in addition to meeting the requirements of s.
Phar 7.05 (1) (a) and
(b), contain a common central processing unit electronically sharing a real-time, on-line database to which both the transferring and receiving pharmacy have access.
Notice of Hearing
Public Instruction
NOTICE IS HEREBY GIVEN That pursuant to s.
227.11 (2) (a), Stats., and interpreting s.
118.51 (3) (a) 1., Stats., the Department of Public Instruction will hold a public hearing as follows to consider the amending of s.
PI 36.03 (1) (d), relating to parental signatures on the open enrollment application.
The hearing will be held as follows:
Date and Time Location
August 29, 2005 Madison
5:00 – 6:00 p.m. GEF 3 Building
125 South Webster St.
Room 041
The hearing site is fully accessible to people with disabilities. If you require reasonable accommodation to access any meeting, please call Mary Jo Cleaver, open enrollment consultant, at (608) 267-9101 or leave a message with the Teletypewriter (TTY) at (608) 267-2427 at least 10 days prior to the hearing date. Reasonable accommodation includes materials prepared in an alternative format, as provided under the Americans with Disabilities Act.
Copies of Rule and Contact Person
Lori Slauson, Administrative Rules and Federal Grants Coordinator
Department of Public Instruction
125 South Webster Street
P.O. Box 7841
Madison, WI 53707
Written comments on the proposed rules received by Ms. Slauson at the above mailing or email address no later than August 31, 2005, will be given the same consideration as testimony presented at the hearing.
Analysis by the Department of Public Instruction
Explanation of agency authority:
The Department is responsible for administering the Public School Open Enrollment Program under s.
118.51, Stats. Section
118.51 (3) (a) 1., Stats., requires parents who wish to participate in the program to submit an application “on a form provided by the department . . ." Further, s.
118.51 (15), Stats., requires the department to prepare and make available to parents the application form required under sub. (3) (a) 1.
Chapter
PI 36 contains the administrative rules for the program, including requirements pertaining to submitting an application for open enrollment.
Because the department is responsible for administering the open enrollment program and the forms required under s.
118.51, Stats., s.
PI 36.03 (1) (d) is being amended pursuant to rule-making authority granted under s.
227.11 (2) (a) and
(b), Stats.
Related statute or rule: None.
Plain language analysis: Section
PI 36.03 (1) (d) requires a parent to sign the open enrollment application form. If parents are divorced or legally separated, both parents are required to sign the form.
This proposed rule would repeal the requirement that both custodial parents must sign the form.
Summary of, and comparison with, existing or proposed federal regulations: There are no similar existing or proposed federal regulations concerning inter-district open enrollment programs.
Comparison with rules in adjacent states:
Illinois has no open enrollment program. Michigan has a limited open enrollment program but there is no application available for review. Iowa and Minnesota have statewide open enrollment programs but do not require more than one signature on the application form.
Summary of factual data and analytical methodologies:
Current administrative rules require a parent to sign the open enrollment application. If parents are divorced or legally separated, both parents are required to sign the form. The Department proposes to repeal the requirement for both custodial parents to sign the form.
This provision was intended to require parents to keep each other informed and to keep school districts out of the middle of the situation. However, it has created a hardship in cases where one custodial parent cannot be located.
In other cases, the rule has had the opposite of the desired effect. The open enrollment period is only three weeks long and custody issues can be very complicated. Three weeks can be too short a time to have the issue resolved, especially when mediation and/or family court are involved. Requiring both signatures before the issue has been resolved reduces the child's educational options. And occasionally, school districts are drawn into the disagreement, rather than be insulated from it.
The open enrollment form is an application only. Allowing one of the custodial parents to sign the form, even without informing the other, is not determinative of where the child must go to school. That question must be resolved in the way all joint custodial decisions are made. But it keeps the open enrollment option open until such time as the parents can make a joint decision.
Analysis and supporting documents used to determine effect on small business or in preparation of economic impact report: None.
Anticipated costs incurred by private sector: None.
Effect on small business: The proposed rules will have no significant economic impact on small businesses, as defined in s.
227.114 (1) (a), Stats.
Fiscal Estimate
These proposed rules have no state or local fiscal effect. The proposed rules have no fiscal effect on small businesses.
Initial Regulatory Flexibility Analysis
The proposed rules are not anticipated to have a fiscal effect on small businesses as defined under s.
227.114 (1) (a), Stats.
Notice of Hearing
Public Instruction
NOTICE IS HEREBY GIVEN That pursuant to ss.
119.23 (2) (b) and
(11) and
227.11 (2) (a), Stats., and interpreting s.
119.23 (2) (b), Stats., the Department of Public Instruction will hold a public hearing as follows to consider emergency rules amending of Chapter
PI 35, relating to the prorate method to be used under the Milwaukee Parental Choice Program. The emergency rules became effective August 1, 2005. The hearing will be held as follows:
Date and Time Location
August 31 , 2005 Milwaukee
4:00 – 6:00 p.m. Milwaukee Area Technical College
700 W. State St.
Room S-120
The hearing site is fully accessible to people with disabilities. If you require reasonable accommodation to access any meeting, please contact Lisa Geraghty, Consultant, Milwaukee Parental Choice Program,
elisabeth.geraghty@dpi.state.wi.us, (608) 266-0523, or leave a message with the Teletypewriter (TTY), (608) 267-2427 at least 10 days prior to the hearing date. Reasonable accommodation includes materials prepared in an alternative format, as provided under the Americans with Disabilities Act.
Copies of Rule and Contact Person
Lori Slauson, Administrative Rules and Federal Grants Coordinator
Department of Public Instruction
125 South Webster Street
P.O. Box 7841
Madison, WI 53707
Written comments on the proposed rules received by Ms. Slauson at the above mailing or email address no later than September 2, 2005, will be given the same consideration as testimony presented at the hearing.
Analysis by the Department of Public Instruction
Explanation of agency authority:
Under s.
119.23 (2) (b), Stats., no more than 15% of the Milwaukee Public Schools' membership may attend private schools participating in the program. If in any school year there are more spaces available in the participating private schools than the maximum number of pupils allowed to participate, the department is required to prorate the number of spaces available at each participating private school. Because the department is interpreting the provisions of this statute and administers/enforces the program governed by it, s.
227.11 (2) (a), Stats., gives the department general rule-making authority.
Section
119.23 (11), Stats., gives the department authority to promulgate rules to implement and administer the entire program.
Court decisions directly relevant: None.
Related statute or rule: None.
Plain language analysis:
Under s.
119.23 (2) (b), Stats., no more than 15% of Milwaukee Public School's (MPS) membership (approximately 15,000 students) may attend private schools under the MPCP. The department is required to prorate the number of spaces available at each participating private school if in any school year there are more spaces available than the maximum number of students allowed to participate in the program.
The proposed rules establish a process by which the number of seats will be prorated among all participating private schools if there are more pupil applications submitted than the statutory limit permits to participate. Under the proposed rule, the application periods for students applying to start school in the fall of 2005 would end by August 20, 2005. The department would calculate the number of spaces available after processing eligible student applications and the private school's 3rd Friday in September membership reports received at the department by October 1, 2005, and divide any remaining spaces by the number of eligible private schools interested in accepting additional students. Each interested school would receive an equal number of spaces. Participating private schools would fill the seats first from their established waiting lists, if applicable, and second from applications accepted in November and December.
Summary of, and comparison with, existing or proposed federal regulations: None.
Comparison with rules in adjacent states: None.
Summary of factual data and analytical methodologies:
The department anticipates the program reaching the 15% cap in the 2005-06 school year. By October 25, 2005, the department will determine the number of seats available, prorate any remaining seats equally among all participating private schools, and notify the private schools of pupils each private school may enroll in the program for the remainder of the school year. The department would like the rule in place as soon as possible in order to provide adequate notice to participating schools and parents.
The prorating process established in this emergency rule is different from that proposed in Clearinghouse Rule (CHR) 04-069 which was objected to by the Assembly Education Reform Committee on October 20, 2004, and the Joint Committee for Review of Administrative Rules on December 16, 2004. To prohibit the department from selecting pupils for the Milwaukee Parental Choice Program on a random basis as proposed in CHR 04-059, Senate Bill 8 and Assembly Bill 8 were introduced in the legislature on January 13 and 18, 2005, respectively. The bills were introduced as required under s.
227.19 (5) (e), Stats., in support of the objection of the committees.
Analysis and supporting documents used to determine effect on small business or in preparation of economic impact report: None.
Anticipated costs incurred by private sector: None.
Fiscal Estimate
Section
119.23 (2) (b), Stats., requires the department to establish a proration method to utilize when there are more spaces available in the participating private schools than the maximum number of pupils allowed to participate. No more than 15% of Milwaukee Public School's (MPS) membership (approximately 15,000 students) may attend private schools under the MPCP. The rules establish a process by which the number of seats will be prorated among all participating private schools if there are more pupil applications submitted than the statutory limit permits to participate.
These rules will not have a fiscal effect on the private schools participating in the program, MPS, the department, or small businesses.
Initial Regulatory Flexibility Analysis
The proposed rules are not anticipated to have a fiscal effect on small businesses as defined under s.
227.114 (1) (a), Stats.
