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Phar 13.13 (title) Returned, damaged and outdated prescription drug and device requirements. (1) Prescription drugs and devices in a facility that are outdated, damaged, deteriorated, misbranded, or adulterated shall be quarantined and physically separated from other prescription drugs and devices until they are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.
Finding of Emergency
The board has made a finding of emergency. The board finds that failure to have the proposed rules in effect on June 1, 2008, the effective date of the applicable provisions of
2007 Wisconsin Act 20, will create a danger to the public health, safety and welfare, by disrupting the wholesale distribution of prescription drugs in the state of Wisconsin.
Notice of Hearing
Pharmacy Examining Board
NOTICE IS HEREBY GIVEN that the Pharmacy Examining Board will hold a public hearing at the time and place indicated below to consider an order to repeal sections
Phar 13.02 (11) (b) to
(e),
13.03,
13.04 and
13.06 (3); to renumber section
Phar 13.02 (11) (f); to renumber and amend section
Phar 13.02 (6); to amend sections
Phar 13.02 (8),
(9),
(11) (intro.) and
(a),
13.05 (2),
13.08,
13.09 (intro.) and
(3),
13.10 (3),
13.11 (1) to
(4),
13.12 (1) to
(3),
13.13 (title) and
(1) to
(4),
13.14 (1) (intro.),
(a) to
(c), and
(2),
13.15 (4),
13.16 and
13.17 (1); and to create sections
Phar 13.02 (3m),
(11) (b) to
(d),
(f) to
(m) and
13.055, relating to the regulation of wholesale prescription drug distributors.
Hearing Information
Date: July 23, 2008
Time: 9:45 a.m.
Location: 1400 East Washington Avenue
(Enter at 55 North Dickinson Street)
Room 121A
Madison, Wisconsin
Appearances at Hearing and Submission of Written Comments
Interested persons are invited to present information at the hearing. Persons appearing may make an oral presentation but are urged to submit facts, opinions and argument in writing as well. Facts, opinions and argument may 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 or by email at
pamela.haack@drl.state.wi.us. Written comments must be received by July 25, 2008, to be included in the record of rule-making proceedings.
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; telephone 608-266-0495; email at pamela.haack@ drl.state.wi.us.
Analysis Prepared by the Department of Regulation and Licensing
Statutes interpreted
Statutory authority
Explanation of agency authority
The Wisconsin Pharmacy Examining Board has authority under ch.
450, Stats., as amended by
2007 Wisconsin Act 20, to promulgate rules for the regulation of wholesale prescription drug distributors.
Related statutes or rules
Plain language analysis
This proposed rule-making order implements the statutory changes set forth in the drug distributor portions of
2007 Wisconsin Act 20. Several key areas are addressed by this proposed rule-making, including, newly required enhanced qualifications for distributor licensing, inspection requirements, identification and qualification of a designated representative, bonding requirements and additional recordkeeping requirements including where appropriate, the maintaining of drug distribution pedigrees.
SECTION 1 requires a licensed manufacturer to maintain and update at least once per month a list of the manufacturer's authorized distributors of record.
SECTION 2 defines “department."
SECTION 3 amends the definition of “wholesale distributor."
SECTION 4 amends the definitions of “facility" and “manufacturer."
SECTION 5 amends the definition of “wholesale distribution."
SECTION 6 repeals portions of the definition of “wholesale distribution" which are no longer applicable.
SECTION 7 amends the definition of “wholesale distribution."
SECTION 8 renumbers and SECTION 9 creates additional provisions for the definition of “wholesale distribution."
SECTION 10 repeals two licensure provisions no longer statutorily required.
SECTION 11 amends a licensure requirement to require proof of an inspection.
SECTION 12 creates a licensure requirement to require a surety bond or irrevocable letter of credit to be filed with the department.
SECTION 13 repeals a requirement that is not statutorily required.
SECTIONS 14 to 19 remove the reference to “devices."
SECTION 20 amends a recordkeeping requirement.
SECTION 21 amends a recordkeeping requirement.
SECTION 22 adds “designated representative" to the list of required responsible persons.
SECTION 23 amends compliance with federal, state and local laws to include the requirement of an electronic track and trace drug pedigree under certain conditions.
Comparison with rules in adjacent states
Minnesota:
Statutes: Ch.
151 - Each separate facility is required to be licensed (with an annual renewal) and must satisfy a number of conditions relating to storage, security, container labeling, records retention (must be separately maintained and available for inspection within 2 working days of a board request), management and ownership, inspection procedures. An annual report to the board is required. The board may adopt reciprocity rules if the other state has comparable legal standards and that state would also extend reciprocal treatment.
Rules: § 6800 – 1400 - Distributors must track the source of all drugs, along with the name and address of the seller or transferor and the address of the location from where the shipment was sent. Records must be kept for two years, and lists of responsible persons must be maintained with a description of duties and qualifications.
Iowa:
Rules: § 657 - An annual renewal is required. Board inspectors inspect new distribution locations in Iowa. Minimum qualifications are specified in rule. Lists of officers, directors, managers and others in charge must be maintained. Distributors must verify the authority of the person or business to whom the distribution is intended prior to distribution. If distribution is to sales or manufacturers' representatives, distributors must ensure they maintain distribution records. There are facility, security, storage and record-keeping requirements included. Transaction records must include the source of the drug, name and address of seller/transferor, and the address from where it is shipped, in addition to the recipient, the name and address of the purchaser or transferee and the address where drugs are shipped. Records must be maintained for two years. The code contains an ethical conduct provision.
Illinois:
Rules: Chapter
111 - It is unlawful to distribute a drug for less than fair market value not in accordance with law.
Michigan:
Statute: Chapter
333 - May designate an individual to be the pharmacy, manufacturer, or wholesale distributor licensee.
Rules: § 338 - All locations used in connection with distribution must be listed in the application. Includes requirements for storage, handling and records. Inspections may be performed “at reasonable times in reasonable places." A manufacturer or distributor may only distribute to persons licensed by the board or licensed to prescribe. Procedures for examining containers received and sent for identity to prevent contamination and ensure fitness for distribution. Must record the source and address of the seller or transferor and the location from where the drugs were shipped. Records must be maintained for two years. There must be written policies for receipt, security, storage, inventory and distribution of drugs, plus a crisis management policy. Identity information for persons in charge of distribution, storage and handling must be maintained.
Summary of factual data and analytical methodologies
Department staff reviewed the portions of
2007 Wisconsin Act 20 that pertain to drug distributorships and laws and rules from other states prior to preparing this proposed rule-making order.
Analysis and supporting documents used to determine effect on small business
The statute requires an inspection of drug distributors to be completed prior to the June 1, 2008 effective date of the rule. A review of the department's license files revealed there are approximately 100 distributors licensed in Wisconsin that may not have been inspected within the three years prior to being licensed. The board set the bond or letter of credit amount at $5,000 after a review of the statutory language and other states' requirements.
Section
227.137, Stats., requires an “agency" to prepare an economic impact report before submitting the proposed rule-making order to the Wisconsin Legislative Council. The Department of Regulation and Licensing is not included as an “agency" in this section.
Initial Regulatory Flexibility Analysis
These rules will have no significant economic impact on a substantial number of small businesses, as defined in s.
227.114 (1), Stats. The $5,000 bond or letter of credit is estimated to cost $200.00 to purchase. The Department's Regulatory Review Coordinator may be contacted by email at
larry.martin@drl.state.wi.us, or by calling 608-266-8608.
Fiscal Estimate
