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)
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)
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:
Provides false or fraudulent records to, or makes a false or fraudulent statement to, the board, a representative of the board, or a federal official.
Obtains or attempts to obtain a prescription drug by fraud, deceit, or misrepresentation, or engages in misrepresentation or fraud in the distribution of a prescription drug.
Manufactures, repackages, sells, transfers, delivers, holds, or offers for sale a prescription drug that is adulterated, misbranded, counterfeit, suspected of being counterfeit, or otherwise unfit for distribution, except for wholesale distribution by a manufacturer of a prescription drug that has been delivered into commerce pursuant to an application approved by the federal food and drug administration.
Adulterates, misbrands, or counterfeits a prescription drug, except for wholesale distribution by a manufacturer of a prescription drug that has been delivered into commerce pursuant to an application approved by the federal food and drug administration.
Receives a prescription drug that has been adulterated, misbranded, stolen, obtained by fraud or deceit, counterfeited, or suspected of being counterfeited, and delivers or proffers such a drug.
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.
(4) Subsection (3)
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
License renewal. 450.08(1)(1)
The renewal date for all licenses granted by the board is specified under s. 440.08 (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)
. Failure to obtain renewal within the time period specified under this paragraph terminates the right of the person to be licensed as a pharmacist, and such right can only be acquired by passing an examination to the satisfaction of the board.
A pharmacy, manufacturer's or distributor'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)
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 American Council on Pharmaceutical 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.
History: 1997 a. 68
; 1997 a. 237
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.
(2) 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.
(3) Pharmaceutical equipment.
Every pharmacy shall be equipped with proper pharmaceutical utensils for compounding and dispensing prescriptions. The board shall prescribe, by rule, minimum standards of professional and technical equipment.
(4) 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.
(5) Display of license.
Every original license issued by the board and the renewal license currently in force, if any, shall be displayed in the place of practice.
(6) 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.
(7) Selection of drugs.
Drug products purchased for subsequent sale and dispensing at a pharmacy shall be selected for purchase by a pharmacist.
(7m) State prisons.
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.
Except as provided under par. (b)
, 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.
Any person who violates sub. (5)
shall forfeit $10 for each separate offense. Each day of violation constitutes a separate offense.
History: 1985 a. 146
; 2003 a. 54
See also ch. Phar 7
, Wis. adm. code.
Duty to dispense contraceptives. 450.095(1)(a)
"Contraceptive drug or device" means any drug or device approved by the federal food and drug administration that is used to prevent pregnancy, including a contraceptive drug or device restricted to distribution by a pharmacy.
"Without delay" means within the usual and customary time frame reasonably expected at a pharmacy for dispensing or distributing a prescription that is not a contraceptive drug or device.
Unless one or more of the following applies, a pharmacy shall dispense lawfully prescribed contraceptive drugs and devices and shall deliver contraceptive drugs and devices restricted to distribution by a pharmacy to a patient without delay:
The prescription contains an obvious or known error or contains inadequate instructions.
The prescription is contraindicated for the patient, is incompatible with another drug or device prescribed for the patient, or is prohibited by state or federal law.
Any person who violates this section may be required to forfeit not less than $250 nor more than $2,500 for each violation.
Nothing in this section may be construed to abrogate a pharmacist's legal and ethical obligations to comply with the laws of this state.
History: 2009 a. 28
Disciplinary proceedings; immunity; orders. 450.10(1)(a)(a)
In this subsection, "unprofessional conduct" includes any of the following, but does not include the dispensing of an antimicrobial drug for expedited partner therapy as described in s. 450.11 (1g)
Making any materially false statement or giving any materially false information in connection with an application for a license or for renewal or reinstatement of a license.
Violating this chapter or, subject to s. 961.38 (4r)
, ch. 961
or any federal or state statute or rule which substantially relates to the practice of the licensee.
Practicing pharmacy while the person's ability to practice is impaired by alcohol or other drugs or physical or mental disability or disease.
Engaging in false, misleading or deceptive advertising.
Making a substantial misrepresentation in the course of practice which is relied upon by another person.
Engaging in conduct in the practice of the licensee which evidences a lack of knowledge or ability to apply professional principles or skills.