Manufacturers; licensure. 450.07(1)(1)
Except as provided under sub. (1m)
, no person may engage in manufacturing in this state unless the person obtains a manufacturer's license from the board. For the issuance of a license under this subsection, the applicant shall pay the initial credential fee determined by the department under s. 440.03 (9) (a)
A license is not required under this section for a person to engage in the manufacturing of hemp, as defined in s. 94.55 (1)
The issuance of licenses under this section is subject to rules the board adopts for the protection of the public health and safety.
The board shall adopt rules prescribing minimum standards for manufacturing and distributing drugs. Rules adopted under this paragraph may not impose requirements regarding the storage of a controlled substance in a safe, a steel cabinet, a vault, or any other secure storage compartment, area, room, or building unless one of the following applies:
The controlled substance is included in schedule I, II, III, or IV under ch. 961
The controlled substance is also a controlled substance under federal law.
The rules adopted by the board under par. (b)
shall require a manufacturer to maintain and to update at least once per month a list of the manufacturer's authorized distributors of record.
See also chs. Phar 12
, Wis. adm. code.
Wholesale distributors; licensure. 450.071(1)(1)
No person may engage in the wholesale distribution of a prescription drug in this state without obtaining a license from the board for each facility from which the person distributes prescription drugs. The board shall exempt a manufacturer that distributes prescription drugs or devices manufactured by the manufacturer from licensing and other requirements under this section to the extent the license or requirement is not required under federal law or regulation, unless the board determines that it is necessary to apply a requirement to a manufacturer.
An applicant shall submit a form provided by the board showing all of the following and swear or affirm the truthfulness of each item in the application:
The name, business address, and telephone number of the applicant.
All trade or business names used by the applicant.
Names, addresses, and telephone numbers of contact persons for all facilities used by the applicant for the storage, handling, and distribution of prescription drugs.
The type of ownership or operation for the applicant's business.
If the applicant's wholesale distribution business is a partnership, the name of each partner and the name of the partnership.
If the applicant's wholesale distribution business is a corporation, the name of each corporate officer and director, the name of the corporation, and the state of incorporation.
If the applicant's wholesale distribution business is a sole proprietorship, the name of the sole proprietor and the name of the business entity.
A list of all licenses and permits issued to the applicant by any other state that authorizes the applicant to purchase or possess prescription drugs.
The name, address, and telephone number of a designated representative.
For the person listed in par. (i)
, a personal information statement that contains all of the following:
The person's places of residence for the 7-year period immediately preceding the date of the application.
The person's occupations, positions of employment, and offices held during the 7-year period immediately preceding the date of the application.
The name and addresses for each business, corporation, or other entity listed in subd. 3.
A statement indicating whether the person has been, during the 7-year period immediately preceding the date of the application, the subject of any proceeding for the revocation of any business or professional license and the disposition of the proceeding.
A statement indicating whether the person has been, during the 7-year period immediately preceding the date of the application, enjoined by a court, either temporarily or permanently, from possessing, controlling, or distributing any prescription drug, and a description of the circumstances surrounding the injunction.
A description of any involvement by the person during the past 7 years with any business, including investments other than the ownership of stock in a publicly traded company or mutual fund, that manufactured, administered, prescribed, distributed, or stored pharmaceutical products or drugs, and a list of any lawsuits in which such a business was named as a party.
A description of any misdemeanor or felony criminal offense of which the person was, as an adult, found guilty, whether adjudication of guilt was withheld or the person pleaded guilty or no contest. If the person is appealing a criminal conviction, the application shall include a copy of the notice of appeal, and the applicant shall submit a copy of the final disposition of the appeal not more than 15 days after a final disposition is reached.
A photograph of the person taken within the 12-month period immediately preceding the date of the application.
A statement that each facility used by the applicant for the wholesale distribution of prescription drugs has been inspected in the 3-year period immediately preceding the date of the application by the board, a pharmacy examining board of another state, the National Association of Boards of Pharmacy, or another accrediting body recognized by the board, with the date of each such inspection.
The board shall grant a license to the applicant to engage in the wholesale distribution of prescription drugs if all of the following apply:
The inspections conducted pursuant to sub. (2) (k)
satisfy requirements adopted by the board for wholesale distribution facilities.
All of the following apply to each person identified by the applicant as a designated representative:
The person has been employed full time for at least 3 years in a pharmacy or with a wholesale prescription drug distributor in a capacity related to the dispensing and distribution of, and record keeping related to, prescription drugs.
The person is employed by the applicant full time in a managerial level position.
The person is physically present at the wholesale prescription drug distributor's facility during regular business hours and is involved in and aware of the daily operation of the wholesale prescription drug distributor. This subdivision does not preclude the designated representative from taking authorized sick leave and vacation time or from being absent from the facility for other authorized business or personal purposes.
The person is actively involved in and aware of the daily operations of the wholesale distributor.
The person is a designated representative for only one applicant at any given time. This subdivision does not apply if more than one wholesale distributor is located at the facility and the wholesale distributors located at the facility are members of an affiliated group.
The person has not been convicted of violating any federal, state, or local law relating to wholesale or retail prescription drug distribution or distribution of a controlled substance.
The person submits to the department 2 fingerprint cards, each bearing a complete set of the applicant's fingerprints. The department of justice shall provide for the submission of the fingerprint cards to the federal bureau of investigation for the purposes of verifying the identity of the applicant and obtaining the applicant's criminal arrest and conviction record. This subdivision does not apply to a person accredited by the national association of boards of pharmacy's verified-accredited wholesale distributor program.
Notwithstanding subs. (2)
, the board may grant a license to engage in the wholesale distribution of prescription drugs to a person who is domiciled in another state and is licensed to engage in the wholesale distribution of prescription drugs in another state, if the board determines that the standards for licensure in the state in which the person is licensed are at least as stringent as the standards for licensure under this section.
The board may set, by rule, continuing education requirements for designated representatives under this section.
The board shall require every wholesale distributor to submit a surety bond acceptable to the board in an amount not to exceed $100,000 or other equivalent means of security acceptable to the board, except that the board shall not require submission of a bond or other security under this subsection by a chain pharmacy warehouse that is engaged only in intracompany transfers. A wholesale distributor that operates more than one facility is not required to submit a bond or other security under this paragraph for each facility.
The bond or other security under this subsection shall be used to secure payment of fees or costs that relate to the issuance of a license under this section and that have not been paid within 30 days after the fees or costs have become final. No claim may be made against a wholesale distributor's bond or other security under this subsection more than one year after the date on which the wholesale distributor's license expires.
Applications for licensure under this section are not subject to inspection or copying under s. 19.35
, and may not be disclosed to any person except as necessary for compliance with and enforcement of the provisions of this chapter.
History: 2007 a. 20
; 2009 a. 180
Wholesale distributors; restrictions on transactions. 450.072(1)(1)
A wholesale distributor shall receive prescription drug returns or exchanges from a pharmacy, a person authorized to administer or dispense drugs, or a pharmacy's intracompany warehouse pursuant to the terms and conditions of the agreement between the wholesale distributor and the pharmacy or chain pharmacy warehouse. A wholesale distributor that receives returns of expired, damaged, recalled, or otherwise nonsaleable prescription drugs may distribute the prescription drugs only to the original manufacturer of the products or to a 3rd party returns processor. Notwithstanding s. 450.073
, returns or exchanges of saleable or nonsaleable prescription drugs, including any redistribution by a receiving wholesaler, are not subject to pedigree requirements under s. 450.073
if the returns or exchanges are exempt from the pedigree requirement under the federal food and drug administration's current guidance on the federal prescription drug marketing act. A person licensed under s. 450.071
or a pharmacy or other person authorized to administer or dispense drugs shall ensure that the person or pharmacy's return process is secure and does not permit the entry of adulterated and counterfeit products.
A manufacturer or wholesale distributor may not deliver prescription drugs to a person unless the person is licensed under s. 450.071
or by the appropriate licensing authority of another state or unless the person is a faculty member of an institution of higher education, as defined in s. 36.32 (1)
, and is obtaining the prescription drugs for the purpose of lawful research, teaching, or testing and not for resale. A manufacturer or wholesale distributor may not deliver prescription drugs to a person that is not known to the manufacturer or wholesale distributor unless the manufacturer or wholesale distributor has verified with the board or with the licensing authority of the state in which the person is located that the person is licensed to receive prescription drugs or unless the person is a faculty member of an institution of higher education, as defined in s. 36.32 (1)
, and is obtaining the prescription drugs for the purpose of lawful research, teaching, or testing and not for resale.
A manufacturer or wholesale distributor may distribute a prescription drug only to the premises listed on the person's license or authorization, except that a manufacturer or wholesale distributor may distribute the prescription drugs to an authorized agent of the person at the premises of the manufacturer or wholesale distributor if all of the following are true:
The manufacturer or wholesale distributor documents the authorized agent's name and address.
Distribution to an authorized agent is necessary to promote or protect the immediate health or safety of the authorized agent's patient.
A manufacturer or wholesale distributor may distribute a prescription drug to a hospital pharmacy receiving area if a licensed pharmacist or another authorized recipient signs, at the time of the distribution, a receipt that shows the type and quantity of prescription drugs distributed. If there is a discrepancy between the type and quantity of prescription drugs indicated on the receipt and the type and quantity of prescription drugs received at the hospital pharmacy receiving area, the discrepancy shall be reported to the manufacturer or wholesale distributor that distributed the prescription drugs no later than the day immediately following the date on which the prescription drugs were distributed to the hospital pharmacy receiving area.
No manufacturer or wholesale distributor may accept payment for, or allow the use of, a person's credit to establish an account for the purchase of a prescription drug from any person other than the owner of record, the chief executive officer, or the chief financial officer identified on the license or authorization of a person who may receive prescription drugs. Any account established for the purchase of prescription drugs shall bear the name of the licensed or authorized person.
History: 2007 a. 20
; 2011 a. 100
Wholesale distributors; pedigree. 450.073(1)(1)
A wholesale distributor shall establish and maintain a pedigree for each prescription drug that leaves, or has ever left, the normal distribution channel. Before a wholesale distribution of a prescription drug leaves the normal distribution channel, a wholesale distributor shall provide a copy of the pedigree to the person receiving the drug. This section does not apply to a retail pharmacy or pharmacy intracompany warehouse unless the pharmacy or pharmacy intracompany warehouse engages in the wholesale distribution of prescription drugs.
A pedigree shall contain all necessary identifying information concerning each sale in the chain of the distribution of the prescription drug from the manufacturer of the prescription drug or the manufacturers 3rd-party logistics provider, colicensed product partner, or exclusive distributor until final sale or distribution to a pharmacy or a person dispensing or distributing the prescription drug. The pedigree shall include all of the following:
The name, address, telephone number, and, if available, electronic mail address of each recipient or distributor of the prescription drug in the chain of distribution, until the final sale or distribution described in sub. (2) (intro.)
The name and address of each facility from which the prescription drug was distributed, if different from the address provided in par. (a)
A certification that every recipient has authenticated the pedigree before distribution of the prescription drug to the next point in the chain of distribution.
The name, dosage strength, size and number of containers, lot number, and name of the manufacturer for each prescription drug.
The board shall promulgate rules implementing an electronic track and trace pedigree system. Not later than July 1, 2010, the board shall determine the date on which the system will be implemented. The system may not be implemented before July 1, 2011, and the board may delay the implementation date in increments if the board determines that the technology to implement the system is not yet universally available across the prescription drug supply chain or is not capable of adequately protecting patient safety.
A person who is engaged in the wholesale distribution of a prescription drug, including a repackager but not including the original manufacturer of the prescription drug, who possesses a pedigree for the prescription drug, and who intends to further distribute the prescription drug, shall verify that each transaction recorded on the pedigree has occurred before the person may distribute the prescription drug.
A pedigree shall be maintained by a person who purchases prescription drugs identified in the pedigree and by a wholesale distributor who distributes prescription drugs identified in the pedigree for not less than 3 years from the date of sale or distribution.
A person maintaining a pedigree under par. (a)
shall make the pedigree available for inspection or use by a law enforcement officer within 7 days after the law enforcement officer's request.
History: 2007 a. 20
Wholesale distributors; prohibited actions, enforcement, penalties. 450.074(1)(1)
If the board finds that there is a reasonable probability that a wholesale distributor, other than a manufacturer, has done any of the following, that continued distribution of a prescription drug involved in the occurrence could cause death or serious adverse health consequences, and that additional procedures would result in an unreasonable delay, the board shall issue an order requiring that distribution of a prescription drug in this state cease immediately:
Falsified a pedigree or sold, distributed, transferred, manufactured, repackaged, handled, or held a counterfeit prescription drug intended for human use.
If the board issues an order under sub. (1)
, the board shall provide the person who is the subject of the order an opportunity for an informal hearing not more than 10 days after the date on which the order is issued. If, after a hearing, the board determines that the order was issued without sufficient grounds, the board shall vacate the order.
Any person who knowingly does any of the following is guilty of a Class H felony: