Alters, mutilates, destroys, obliterates, or removes any part of the labeling of a prescription drug or commits another act that results in the misbranding of a prescription drug.
does not apply to a prescription drug manufacturer or an agent of a prescription drug manufacturer, if the manufacturer or agent is obtaining or attempting to obtain a prescription drug for the sole purpose of testing the authenticity of the prescription drug.
History: 2007 a. 20
Third-party logistics providers; licensure. 450.075(1)(1)
A person acting as a 3rd-party logistics provider or an out-of-state 3rd-party logistics provider of any drug or device may apply to obtain a license from the board under this section. If operations are conducted at more than one facility, a person acting as a 3rd-party logistics provider or out-of-state 3rd-party logistics provider may apply to obtain a license from the board for each such facility.
An applicant for a license under this section 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 warehousing, distribution, or other services on behalf of the manufacturer of prescription drugs.
The type of ownership or operation for the applicant's business.
If the applicant's 3rd-party logistics provider business is a partnership, the name of each partner and the name of the partnership.
If the applicant's 3rd-party logistics provider 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 3rd-party logistics provider 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 warehouse or distribute prescription drugs.
The name, address, and telephone number of a designated representative.
For the person identified as the designated representative in par. (i)
, a personal information statement that contains all of the following:
The person's place 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 person 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 3rd-party logistics provider services 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 an applicant to act as a 3rd-party logistics provider or an out-of-state 3rd-party logistics provider if all of the following apply:
The inspections conducted pursuant to sub. (2) (k)
satisfy requirements adopted by the board for 3rd-party logistics providers or out-of-state 3rd-party logistics providers.
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 of and distribution of, and record keeping related to, prescription drugs.
The person is employed by the applicant full time in a managerial position.
The person is physically present at the 3rd-party logistics provider's or out-of-state 3rd-party logistics provider's facility during regular business hours and is involved in and aware of the daily operation of the 3rd-party logistics provider or the out-of-state 3rd-party logistics provider. This subdivision does not preclude the person 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 operation of the 3rd-party logistics provider or the out-of-state 3rd-party logistics provider.
The person is a designated representative for only one applicant at any given time. This subdivision does not apply if more than one 3rd-party logistics provider or out-of-state 3rd-party logistics provider is located at the facility and the 3rd-party logistics providers or out-of-state 3rd-party logistics providers 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 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 purposes of verifying the identity of the person and obtaining the person's criminal arrest and conviction record.
The applicant satisfies any other requirements established by the board by rule.
The board shall promulgate rules implementing this section. The rules shall ensure compliance with the federal drug supply chain security act, 21 USC 360eee
, et seq. The board may not promulgate rules that impose requirements more strict than the federal drug supply chain security act or any regulations passed under the federal drug supply chain security act. The board may not promulgate rules that require a license under this section.
Access to records.
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.
A 3rd-party logistics provider or an out-of-state 3rd-party logistics provider shall allow the board and authorized federal, state, and local law enforcement officials to enter and inspect its facilities and delivery vehicles, to audit its records and written operating procedures, and to confiscate prescription drugs and records to the extent authorized by law, rule, or regulation.
If the federal government establishes a licensing program for 3rd-party logistics providers, the board shall evaluate the federal licensing program to determine whether licensing by this state of resident 3rd-party logistics providers is required for a resident 3rd-party logistics provider to provide 3rd-party logistics provider services in another state. If the board determines under this subsection that licensing by this state is not required, this section does not apply.
By April 17, 2023, and biennially thereafter, the board shall evaluate whether continued licensing by this state of resident 3rd-party logistics providers is required for a resident 3rd-party logistics provider to provide 3rd-party logistics provider services in another state and, if the board determines licensing in this state is required, submit to the legislative reference bureau for publication in the Wisconsin Administrative Register a notice continuing the licensing under this section. This section does not apply unless the board submits the notice under this paragraph.
History: 2021 a. 25
; s. 35.17 correction in (1), (4).
Home medical oxygen providers; licensure. 450.076(1)(a)
“Home medical oxygen provider" means a person that provides medical oxygen directly to a consumer or patient in this state for that consumer's or patient's own use.
“Licensed provider" means a home medical oxygen provider licensed under this section.
“Medical oxygen" means oxygen that is a prescription drug.
Except as provided in par. (b)
, no person may operate as a home medical oxygen provider, use the title “home medical oxygen provider" or any similar title, or hold itself out as a home medical oxygen provider unless the person is a licensed provider.
No license under this section is required for any of the following:
A hospital, excluding any home medical oxygen provider that is owned or operated by a hospital.
An employee or agent of a licensed provider acting within the scope of his or her employment or agency.
The board may grant a license to act as a home medical oxygen provider to a person that does all of the following:
Submits an application for licensure on a form provided by the board.
Satisfies any other requirements established by the board by rule.
The board shall promulgate rules implementing this section. The rules shall include rules governing the professional conduct of licensed providers and their employees and agents.
History: 2015 a. 3
License renewal. 450.08(1)(1)
The renewal date for all licenses granted by the board is specified under s. 440.08 (2) (a)
. Except as provided under sub. (2) (a)
, only a holder of an unexpired license may engage in his or her licensed activity.
A pharmacist's license may be renewed by complying with continuing education requirements under s. 450.085
and paying the applicable fee determined by the department under s. 440.03 (9) (a)
on or before the applicable renewal date specified under s. 440.08 (2) (a)
. Notwithstanding s. 440.08 (3) (a)
, if a pharmacist fails to obtain renewal by that date, the board may suspend the pharmacist's license, and the board may require the pharmacist to pass an examination to the satisfaction of the board to restore that license.
A pharmacy, manufacturer's, distributor's, or home medical oxygen provider's license may be renewed by paying the applicable fee determined by the department under s. 440.03 (9) (a)
on or before the applicable renewal date specified under s. 440.08 (2) (a)
Continuing education. 450.085(1)(1)
An applicant for renewal of a license under s. 450.08 (2) (a)
shall submit proof that he or she has completed, within the 2-year period immediately preceding the date of his or her application, 30 hours of continuing education in courses conducted by a provider that is approved by the Accreditation Council for Pharmacy Education or in courses approved by the board. Courses specified in s. 450.035 (1r)
are courses in continuing education for purposes of this subsection. This subsection does not apply to an applicant for renewal of a license that expires on the first renewal date after the date on which the board initially granted the license.
The board may waive all or part of any requirement in sub. (1)
if it finds that exceptional circumstances such as prolonged illness, disability or other similar circumstances have prevented a pharmacist from meeting the requirement.
See also ch. Phar 16
, Wis. adm. code.
Pharmacy practice. 450.09(1)(a)(a)
Every pharmacy shall be under the control of the managing pharmacist who signed the pharmacy license application, the most recent license renewal application or the most recent amended schedule of operations. The managing pharmacist shall be responsible for the professional operations of the pharmacy. A pharmacist may be the managing pharmacist of not more than one community and one institutional pharmacy at any time and shall be engaged in the practice of pharmacy at each location he or she supervises. The board shall by rule define community pharmacy and institutional pharmacy for the purposes of this section.
If the managing pharmacist anticipates being continuously absent for a period of more than 30 days from a pharmacy he or she supervises, the managing pharmacist shall delegate the supervisory responsibility to another pharmacist for the duration of the absence by written power of attorney which shall be kept on file in the pharmacy to which the power of attorney applies. The pharmacist designated to assume the supervisory responsibility for the pharmacy during the managing pharmacist's absence shall be engaged in the practice of pharmacy at the pharmacy to which the power of attorney applies.
Presence of pharmacist.
No pharmaceutical service may be provided to any person unless a pharmacist is present in the pharmacy to provide or supervise the service.
Condition of pharmacy.
The pharmacy shall be maintained in a clean and orderly manner and the professional service area shall be equipped with proper fixtures and equipment for sanitation.
Medication profile record system.
Every pharmacy shall maintain a medication profile record system of all drug products dispensed for a particular patient according to the minimum standards for such systems established by the board by rule. Every practitioner shall maintain a record of all drug products dispensed to each patient according to standards established by the appropriate examining board by rule. The standards established by each examining board shall require the recording of all renewal dispensing information required by federal and state law and related rules and regulations.
Selection of drugs.
Drug products purchased for subsequent sale and dispensing at a pharmacy shall be selected for purchase by a pharmacist.
A prescription drug that is returned to a pharmacy that primarily serves patients confined in a state prison may be dispensed to any patient in any state prison, but only if all of the following are satisfied:
The prescription drug was never in the possession of the patient to whom it was originally prescribed.
The prescription drug is returned in its original container.
A pharmacist determines that the prescription drug has not been adulterated or misbranded.
Any person who violates this section may be assessed a forfeiture of not less than $25 nor more than $50 for each separate offense. Each day of violation constitutes a separate offense.