(3) Appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, devices, and/or or logs shall be utilized to document proper storage of prescription drugs and devices.
(4) The recordkeeping requirements in s.
Phar 13.14 shall be followed for all stored drugs
and devices.
SECTION 18. Phar 13.12 (1) to (3) are amended to read:
Phar 13.12 Examination of materials requirements. (1) Upon receipt by a facility, each outside shipping container shall be visually examined for identity and to prevent the acceptance of contaminated prescription drugs or devices, or prescription drugs or devices that are otherwise unfit for distribution. This examination shall be adequate to reveal container damage that would suggest possible contamination or other damage to the contents.
(2) Each outgoing shipment from a facility shall be carefully inspected for identity of the prescription drug or device and to ensure that there is no delivery of prescription drugs or devices that have been damaged in storage or held under improper conditions.
(3) The recordkeeping requirements in s.
Phar 13.14 shall be followed for all incoming and outgoing prescription drugs
and devices at a facility.
SECTION 19. Phar 13.13 (title) and (1) to (4) are amended to read:
Phar 13.13 (title) Returned, damaged and outdated prescription drug and device requirements. (1) Prescription drugs and devices in a facility that are outdated, damaged, deteriorated, misbranded, or adulterated shall be quarantined and physically separated from other prescription drugs and devices until they are destroyed or returned to their supplier.
(2) Any prescription drugs or devices in a facility whose immediate or sealed outer or sealed secondary containers have been opened or used shall be identified as such, and shall be quarantined and physically separated from other prescription drugs and devices until they are either destroyed or returned to the supplier.
(3) If the conditions under which a prescription drug or device has been returned to a facility cast doubt on the product's safety, identity, strength, quality, or purity, then the product shall be destroyed, or returned to the supplier, unless examination, testing, or other investigation proves that the product meets appropriate standards of safety, identity, strength, quality, and purity. In determining whether the conditions under which a product has been returned cast doubt on its safety, identity, strength, quality, or purity, the distributor shall consider, among other things, the conditions under which the product has been held, stored, or shipped before or during its return and the condition of the product and its container, carton, or labeling, as a result of storage or shipping.
(4) The recordkeeping requirements in s.
Phar 13.14 shall be followed for all outdated, damaged, deteriorated, misbranded, or adulterated prescription drugs
and devices.
SECTION 20. Phar 13.14 (1) (intro.) and (a) to (c), and (2) are amended to read:
Phar 13.14 Recordkeeping requirements. (1) (intro.) A distributor shall establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of prescription drugs and devices. These records shall include the following information:
(a) The source of the drugs or device, including the name and principal address of the seller or transferor, and the address of the location from which the drugs or devices were shipped;
(b) The identity and quantity of the drugs or devices received and distributed or disposed of; and
(c) The dates of receipt and distribution or other disposition of the drugs or devices.
(2) Inventories and records shall be made available for inspection and copying by the board, its authorized representatives, and authorized representatives of federal, state and local law enforcement agencies for a period of 2 3 years following distribution or other disposition of the drugs or devices.
SECTION 21. Phar 13.15 (intro.), (1), (2) (intro.) and (b), and (4) are amended to read:
Phar 13.15 Written policies and procedures. (intro.) A distributor shall establish, maintain, and adhere to written policies and procedures, which shall be followed for the receipt, security, storage, inventory, and distribution of prescription drugs and devices, including policies and procedures for identifying, recording, and reporting losses or thefts, and for correcting all errors and inaccuracies in inventories. A distributor shall include in their written policies and procedures the following:
(1) A procedure to ensure that the oldest approved stock of a prescription drug or device is distributed first. The procedure may permit deviation from this requirement if the deviation is temporary and appropriate.
(2) (intro.) A procedure to be followed for handling recalls and withdrawals of prescription drugs and devices. The procedure shall be adequate to deal with recalls and withdrawals due to:
(b) Any voluntary action by the manufacturer to remove defective or potentially defective drugs or devices from the market; or
(4) A procedure to ensure that any outdated prescription drugs or devices are segregated from other products and either returned to the manufacturer or destroyed. This procedure shall provide for written documentation of the disposition of outdated prescription drugs or devices. This documentation shall be maintained for 2 3 years after disposition of the outdated drugs or devices.
SECTION 22. Phar 13.16 is amended to read:
Phar 13.16 Responsible persons. A distributor shall establish and maintain lists of officers, directors, managers, and other persons the designated representative in charge of wholesale drug and device distribution, storage, and handling, including a description of their duties and a summary of their qualifications.
SECTION 23. Phar 13.17 (1) is amended to read:
Phar 13.17 Compliance with federal, state and local laws. (1) A distributor shall operate in compliance with applicable federal, state, and local laws and regulations. A distributor shall operate in compliance with any applicable federal electronic track and trace pedigree system implemented after July 1, 2011, unless an earlier implementation date is mandated by federal law which explicitly preempts state law. A distributor that deals in controlled substances shall register with the drug enforcement administration.
Notice of Hearing
Public Instruction
NOTICE IS HEREBY GIVEN That pursuant to ss.
115.42 (4) and
227.11 (2) (a), Stats., and interpreting ss.
115.42, Stats., the Department of Public Instruction will hold a public hearing as follows to consider emergency and proposed permanent rules amended under Chapter
PI 37, relating to grants for national teacher certification and master educator licensure. The hearing will be held as follows:
Hearing Information
Date and Time Location
July 23, 2008 Madison
3:00 - 4:30 p.m. GEF 3 Building, Room 041
125 South Webster Street
The hearing site is fully accessible to people with disabilities. If you require reasonable accommodation to access any meeting, please call Tammy Huth, Assistant Director, Teacher Education, Professional Development and Licensing, at (608) 266-1788 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
Submission of Written Comments
Written comments on the proposed rules received by Ms. Slauson at the above mail or email address no later than July 29, 2008, will be given the same consideration as testimony presented at the hearing.
Agency Contact Person
Tammy Huth, Assistant Director, Teacher Education, Professional Development and Licensing, (608) 266-1788 or
tammy.huth@dpi.wi.gov.
Analysis Prepared by the Department of Public Instruction
Statute interpreted
Statutory authority
Explanation of agency authority
Section
115.42 (4), Wis. Stats., requires the department to promulgate rules to implement and administer this program, including all of the following:
•
The application process, including necessary documentation.
•
The selection process for grant recipients.
•
The number of times that a teacher may be exempt from continuing professional education requirements.
Related statute or rule
Chapter
PI 34, Wis. Admin. Code.
Plain language analysis
There are two ways an individual may receive a grant under the national teacher certification or master educator licensure program under s.
115.42, Stats.:
•
Through a national process by obtaining a national certificate issued by the National Board for Professional Teaching Standards (NBPTS).
•
Through a state process by completing the Wisconsin master educator assessment process.
Previous language under s.
115.42, Stats., allowed only persons certified through the national process to be awarded grants of up to $2,000 for the first year and $2,500 annually for nine years thereafter if certain conditions were met.
2007 Wisconsin Act 20, the biennial budget bill, modified s.
115.42, Stats., to allow persons receiving master educator licenses through the state process to also receive the grants. In addition, the Act provided an incentive to grant recipients to work in high poverty schools. Finally, the Act allows master educators through the state process to be exempt from continuing education requirements as are teachers certified through the national process.
To reflect statutory language, Chapter
PI 37, Wis. Admin. Code, relating to Grants for National Teacher Certification, is being modified to: 1) allow master educators that have completed the Wisconsin master educator assessment process to receive a grant under the program, 2) allow master educators receiving licenses through the state process or teachers certified through the national process to receive $5,000 (rather than $2,500) if they work in a school in which at least 60 percent of the pupils enrolled are eligible for free or reduced-price lunch, and 3) allow master educators receiving licenses through the state process to be exempt from continuing education requirements.
The rules are also being modified to clarify that:
•
The term “teacher" includes school psychologists, school counselors, and school social workers who are not under contract as an administrator.
•
A teacher must be working as an instructor, school psychologist, school counselor, or school social worker for a minimum of 40 percent full-time equivalency for at least 180 days in a school year to qualify for a grant.
•
A teacher may renew his or her 10-year national board certification or Wisconsin master educator license and continue receiving a grant under this program.
The provisions allowing teachers who have completed the state process to receive grants under this program first applies to persons who were licensed as Wisconsin master educators by the department on or after July 1, 2005.
The provision allowing teachers to receive $5,000, rather than $2,500, if employed in high poverty districts first applies to persons applying for a grant on or after July 1, 2007.
The provision requiring an applicant to work 40 percent full-time equivalency for at least 180 days in a school year first applies to persons applying for a grant on or after July 1, 2008.
Emergency rules were promulgated effective May 17, 2008, in order to establish the new application criteria and procedures to award grants to eligible applicants in the 2007-08 school year.
Comparison with federal regulations
None
Comparison with rules in adjacent states
Michigan and Minnesota - do not have rules relating to grants for national board certified teachers or state certified master educators.
Iowa - As of December 31, 2007, funds will no longer be available to new candidates. However, Iowa did provide a grant program to national board certified teachers (NBCTs) prior to that date. NBCTs that received the grant will be able to complete the 10 year grant process. To be eligible, an applicant must meet all of the following:
•
The individual is a national board certified (NBC) teacher.
•
The individual is a teacher.
•
The individual is employed by a school district in Iowa.
•
The individual receives a salary as a classroom teacher.
•
The individual completes the application process.
•
The individual has not received an NBC annual award for more than ten years.
The initial award is for one-half of the reimbursement fee charged by the NBPTS, or a prorated amount, if funds are not available.
An eligible teacher who received NBC certification prior to May 1, 2000, will receive an annual award of up to $5,000 or a prorated amount for a period of ten years or until the teacher's total state annual award amount reaches $50,000. An eligible teacher who received NBC certification after May 1, 2000 will receive an annual award of up to $2,500 or a prorated amount for a maximum of ten years. An otherwise eligible teacher who possesses a teaching contract that is less than full-time shall receive an award prorated to reflect the type of contract (i.e. half-time, quarter-time, etc.).
It is unclear as to whether Iowa has a state master educator certification process.
Illinois – Requires persons holding a certificate issued by the NBPTS to apply for a master certificate. Holders of an Illinois master certificate who are employed for no less than the equivalent of half of the school year as a teacher or school counselor in a public school setting are eligible for a $3,000 stipend. If funding is limited, this amount may be prorated and grant awards may be prioritized. Holders of an Illinois master certificate shall be eligible for an annual incentive payment for each year during which:
•
He or she holds a certificate issued by the NBPTS.
