piers109uk/MN-Statutes huggingface dataset:
151.35 DRUGS, ADULTERATION.
A drug shall be deemed to be adulterated:
(1) if it consists in whole or in part of any filthy, putrid or decomposed substance; or if it has been produced, prepared, packed, or held under unsanitary conditions whereby it may have been rendered injurious to health, or whereby it may have been contaminated with filth; or if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice as required under the federal act to assure that such drug is safe and has the identity, strength, quality, and purity characteristics, which it purports or is represented to possess; or the facility in which it was produced was not registered by the United States Food and Drug Administration or licensed by the board; or, its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or it bears or contains, for purposes of coloring only, a color additive which is unsafe within the meaning of the federal act, or it is a color additive, the intended use of which in or on drugs is for the purposes of coloring only, and is unsafe within the meaning of the federal act;
(2) if it purports to be or is represented as a drug the name of which is recognized in the United States Pharmacopoeia or the National Formulary, and its strength differs from, or its quality or purity falls below, the standard set forth therein. Such determination as to strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in such compendium, or in the absence of or inadequacy of such tests or methods of assay, those prescribed under authority of the federal act. No drug defined in the United States Pharmacopoeia or the National Formulary shall be deemed to be adulterated under this paragraph because it differs from the standard of strength, quality, or purity therefor set forth in such compendium, if its difference in strength, quality, or purity from such standard is plainly stated on its label;
(3) if it is not subject to the provisions of paragraph (2) and its strength differs from, or its purity or quality differs from that which it purports or is represented to possess;
(4) if any substance has been mixed or packed therewith so as to reduce its quality or strength, or substituted wholly or in part therefor.
151.36 DRUGS, MISBRANDING.
A drug shall be deemed to be misbranded:
(1) if its labeling is false or misleading in any particular;
(2) if in package form and not dispensed pursuant to a prescription unless it bears a label containing (a) the name and place of business of the manufacturer, packer, or distributor, (b) a statement of ingredients, and (c) an accurate statement of the net quantity of the contents in terms of weight, measure, or numerical count, provided, however, that under (c) reasonable variations shall be permitted, and exceptions as to small packages shall be allowed in accordance with the federal act;
(3) if any word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs or devices, in the labeling) and in such terms as to render it to be read and understood by the ordinary individual under customary conditions of purchase and use;
(4) if it otherwise fails to meet the labeling requirements of the federal act.
151.34 PROHIBITED ACTS.
It shall be unlawful to:
(1) manufacture, sell or deliver, hold or offer for sale any drug that is adulterated or misbranded;
(2) adulterate or misbrand any drug;
(3) receive in commerce any drug that is adulterated or misbranded, and to deliver or proffer delivery thereof for pay or otherwise;
(4) refuse to permit entry or inspection, or to permit the taking of a sample, or to permit access to or copying of any record as authorized by this chapter;
(5) remove or dispose of a detained or embargoed article in violation of this chapter;
(6) alter, mutilate, destroy, obliterate, or remove the whole or any part of the labeling of, or to do any other act with respect to a drug, if such act is done while such drug is held for sale and results in such drug being adulterated or misbranded;
(7) use for a person's own advantage or to reveal other than to the board or its authorized representative or to the courts when required in any judicial proceeding under this chapter any information acquired under authority of this chapter concerning any method or process that is a trade secret and entitled to protection;
(8) use on the labeling of any drug any representation or suggestion that an application with respect to such drug is effective under the federal act or that such drug complies with such provisions;
(9) in the case of a manufacturer, packer, or distributor offering legend drugs for sale within this state, fail to maintain for transmittal or to transmit, to any practitioner licensed by applicable law to administer such drug who makes written request for information as to such drug, true and correct copies of all printed matter that is required to be included in any package in which that drug is distributed or sold, or such other printed matter as is approved under the federal act. Nothing in this paragraph shall be construed to exempt any person from any labeling requirement imposed by or under provisions of this chapter;
(10) conduct a pharmacy without a pharmacist in charge;
(11) dispense a legend drug without first obtaining a valid prescription for that drug;
(12) conduct a pharmacy without proper registration with the board;
(13) practice pharmacy without being licensed to do so by the board;
(14) sell at retail federally restricted medical gases without proper registration with the board except as provided in this chapter; or
(15) sell any compound, substance, or derivative that is not approved for human consumption by the United States Food and Drug Administration or specifically permitted for human consumption under Minnesota law, and, when introduced into the body, induces an effect similar to that of a Schedule I or Schedule II controlled substance listed in section 152.02, subdivisions 2 and 3, or Minnesota Rules, parts 6800.4210 and 6800.4220, regardless of whether the substance is marketed for the purpose of human consumption.
151.361 MANUFACTURER DISCLOSURE.
The manufacturer, packager, or distributor of any human use legend drug sold, delivered, or offered for sale in the state of Minnesota after January 1, 1976 must have printed on the label on the immediate container of the drug the name and address of the manufacturer of the finished dosage form of the drug.
(a) No legend drug in solid oral dosage form may be manufactured, packaged or distributed for sale in this state after January 1, 1983 unless it is clearly marked or imprinted with a symbol, number, company name, words, letters, national drug code or other mark uniquely identifiable to that drug product. An identifying mark or imprint made as required by federal law or by the federal Food and Drug Administration shall be deemed to be in compliance with this section.
(b) The Board of Pharmacy may grant exemptions from the requirements of this section on its own initiative or upon application of a manufacturer, packager, or distributor indicating size or other characteristics that render the product impractical for the imprinting required by this section.
Failure to comply with the requirements of this section shall subject a drug to embargo in accordance with section 151.38.
151.38 EMBARGOES.
(1) Whenever a duly authorized agent of the board finds or has probable cause to believe that any drug or medicine is adulterated, or so misbranded as to be dangerous or fraudulent, or is being sold, delivered, or offered for sale in violation of section 151.361, the agent shall affix thereto an appropriate marking, giving notice that the article is, or is suspected of being, adulterated, misbranded or sold, delivered, or offered for sale in violation of section 151.361 and has been embargoed, and warning that it is unlawful for any person to remove or dispose of the embargoed article by sale or otherwise without permission from the agent or the court.
(2) When an embargoed article has been found by the agent to be adulterated or misbranded, or is being sold, delivered, or offered for sale in violation of section 151.361, the board shall, within 30 days, petition the district court in whose jurisdiction the article is embargoed for an order of condemnation. When an embargoed article is not so found by the agent, the agent shall remove the marking.
(3) If the court finds that an embargoed article is adulterated or misbranded, or is being sold, delivered, or offered for sale in violation of section 151.361, the article shall be destroyed at the expense of the claimant thereof, who shall also pay all court costs and fees, storage and other proper expenses. If the adulteration or misbranding, or lack of manufacturer disclosure as required by section 151.361 can be corrected by proper labeling or processing of the article, or by filing the proper documents with the court, the court, after the costs, fees, and expenses have been paid and a sufficient bond has been executed, may order that the article be delivered to the claimant for labeling, processing or filing under supervision of an agent of the board. The expense of the supervision shall be paid by claimant. The bond shall be returned to the claimant on the representation to the court by the board that the article is no longer in violation of this chapter and that the expenses of supervision have been paid.
151.39 DISTRESSED DRUGS.
Distressed drugs shall mean drugs or medicines which have been subjected to accident, fire, flood, adverse temperatures, or other physical influences which could affect the potency, quality, purity, or efficacy of such drug or medicine could otherwise cause the drug or medicine to be adulterated or misbranded within the meaning of the provisions of this chapter.
No person shall sell, barter, vend, give away, or exchange distressed drugs until the board has determined that such drugs are not adulterated or misbranded within the meaning of this chapter.
Every person who owns or controls distressed drugs shall immediately notify the board of the existence of such drugs and the location thereof and the board shall promptly cause an inspection and examination to be made of such drugs.
No person may import distressed drugs into this state without notification to the board of the source, destination, kind and quantity of such drugs. Such drugs may not be sold or offered for sale without written approval of the board. The board shall grant such approval when the applicant has clearly demonstrated that such distressed drugs were inspected on the site within a reasonable period after the occurrence set forth in subdivision 1 by an agency of the foreign state satisfactory to the board and the furnishing of a written certification by such agency in such form as is satisfactory to the board indicating that there is no reasonable cause to believe the drugs are not adulterated or misbranded. Nothing herein shall be construed to prevent the board from exerting its authority and rights set forth in section 151.38 after such drugs have entered this state.
The board shall, within 30 days of such notification, indicate whether or not it has probable cause to believe that such drugs are adulterated or misbranded within the meaning of this chapter. If the board determines that no such probable cause exists, it shall furnish the owner or person having control of such drugs a written certificate to that effect. If the board has probable cause to believe that the drugs are adulterated or misbranded, it shall follow the procedure set forth in section 151.38.
152.152 STAYED SENTENCE LIMITED.
If a person is convicted under section 152.021, 152.022, 152.023, or 152.0262, and the Sentencing Guidelines grid calls for a presumptive prison sentence for the offense, the court may stay imposition or execution of the sentence only as provided in this section. The sentence may be stayed based on amenability to probation only if the offender presents adequate evidence to the court that the offender has been accepted by, and can respond to, a treatment program that has been approved by the commissioner of human services. The court may impose a sentence that is a mitigated dispositional departure on any other ground only if the court includes as a condition of probation incarceration in a local jail or workhouse.
151.43 SCOPE.
Sections 151.43 to 151.471 apply to any person engaging in the wholesale distribution of drugs within the state and to persons operating as third-party logistics providers.
152.205 LOCAL REGULATIONS.
Sections 152.01, subdivision 18, and 152.093 to 152.095 do not preempt enforcement or preclude adoption of municipal or county ordinances prohibiting or otherwise regulating the manufacture, delivery, possession, or advertisement of drug paraphernalia.
152.20 PENALTIES UNDER OTHER LAWS.
Any penalty imposed for violation of this chapter is in addition to, and not in lieu of, any civil or administrative penalty or sanction otherwise authorized by law.
151.46 PROHIBITED DRUG PURCHASES OR RECEIPT.
It is unlawful for any person to knowingly purchase or receive a prescription drug from a source other than a person or entity licensed under the laws of the state, except where otherwise provided. Licensed wholesale drug distributors and licensed third-party logistics providers shall not dispense or distribute drugs directly to patients. A person violating the provisions of this section is guilty of a misdemeanor.
152.23 LIMITATIONS.
(a) Nothing in sections 152.22 to 152.37 permits any person to engage in and does not prevent the imposition of any civil, criminal, or other penalties for:
(1) undertaking any task under the influence of medical cannabis that would constitute negligence or professional malpractice;
(2) possessing or engaging in the use of medical cannabis:
(i) on a school bus or van;
(ii) on the grounds of any preschool or primary or secondary school;
(iii) in any correctional facility; or
(iv) on the grounds of any child care facility or home day care;
(3) vaporizing or combusting medical cannabis pursuant to section 152.22, subdivision 6:
(i) on any form of public transportation;
(ii) where the vapor would be inhaled by a nonpatient minor child or where the smoke would be inhaled by a minor child; or
(iii) in any public place, including any indoor or outdoor area used by or open to the general public or a place of employment as defined under section 144.413, subdivision 1b; and
(4) operating, navigating, or being in actual physical control of any motor vehicle, aircraft, train, or motorboat, or working on transportation property, equipment, or facilities while under the influence of medical cannabis.
(b) Nothing in sections 152.22 to 152.37 require the medical assistance and MinnesotaCare programs to reimburse an enrollee or a provider for costs associated with the medical use of cannabis. Medical assistance and MinnesotaCare shall continue to provide coverage for all services related to treatment of an enrollee's qualifying medical condition if the service is covered under chapter 256B or 256L.
152.24 FEDERALLY APPROVED CLINICAL TRIALS.
The commissioner may prohibit enrollment of a patient in the registry program if the patient is simultaneously enrolled in a federally approved clinical trial for the treatment of a qualifying medical condition with medical cannabis. The commissioner shall provide information to all patients enrolled in the registry program on the existence of federally approved clinical trials for the treatment of the patient's qualifying medical condition with medical cannabis as an alternative to enrollment in the patient registry program.
152.26 RULEMAKING.
(a) The commissioner may adopt rules to implement sections 152.22 to 152.37. Rules for which notice is published in the State Register before January 1, 2015, may be adopted using the process in section 14.389.
(b) The commissioner may adopt or amend rules, using the procedure in section 14.386, paragraph (a), to implement the addition of dried raw cannabis as an allowable form of medical cannabis under section 152.22, subdivision 6, paragraph (a), clause (4). Section 14.386, paragraph (b), does not apply to these rules.
152.261 RULES; ADVERSE INCIDENTS.
(a) The commissioner of health shall adopt rules to establish requirements for reporting incidents when individuals who are not authorized to possess medical cannabis under sections 152.22 to 152.37 are found in possession of medical cannabis. The rules must identify professionals required to report, the information they are required to report, and actions the reporter must take to secure the medical cannabis.
(b) The commissioner of health shall adopt rules to establish requirements for law enforcement officials and health care professionals to report incidents involving an overdose of medical cannabis to the commissioner of health.
(c) Rules must include the method by which the commissioner will collect and tabulate reports of unauthorized possession and overdose.
151.461 GIFTS TO PRACTITIONERS PROHIBITED.
It is unlawful for any manufacturer or wholesale drug distributor, or any agent thereof, to offer or give any gift of value to a practitioner. A medical device manufacturer that distributes drugs as an incidental part of its device business shall not be considered a manufacturer, a wholesale drug distributor, or agent under this section. As used in this section, "gift" does not include:
(1) professional samples of a drug provided to a prescriber for free distribution to patients;
(2) items with a total combined retail value, in any calendar year, of not more than $50;
(3) a payment to the sponsor of a medical conference, professional meeting, or other educational program, provided the payment is not made directly to a practitioner and is used solely for bona fide educational purposes;
(4) reasonable honoraria and payment of the reasonable expenses of a practitioner who serves on the faculty at a professional or educational conference or meeting;
(5) compensation for the substantial professional or consulting services of a practitioner in connection with a genuine research project;
(6) publications and educational materials; or
(7) salaries or other benefits paid to employees.
152.291 TRIBAL MEDICAL CANNABIS PROGRAM MANUFACTURER TRANSPORTATION.
(a) A Tribal medical cannabis program manufacturer may transport medical cannabis to testing laboratories in the state and to other Indian lands.
(b) A Tribal medical cannabis program manufacturer must staff a motor vehicle used to transport medical cannabis with at least two employees of the manufacturer. Each employee in the transport vehicle must carry identification specifying that the employee is an employee of the manufacturer, and one employee in the transport vehicle must carry a detailed transportation manifest that includes the place and time of departure, the address of the destination, and a description and count of the medical cannabis being transported.
151.56 COUNTY RETURN OF UNUSED DRUGS OR MEDICAL DEVICES.
Notwithstanding Minnesota Rules, part 6800.2700, pharmacies may accept returns of and redispense unopened, unused drugs in board-approved unit dose packaging and medical devices from county jails and juvenile correctional facilities. In order to return unused drugs and medical devices, the county jail or juvenile correctional facility must have a correctional employee trained in the delivery and storage of medications on hand 24 hours a day, seven days a week, and the medication must be stored in a secured locked storage locker.
152.30 PATIENT DUTIES.
(a) A patient shall apply to the office for enrollment in the registry program by submitting an application as required in section 152.27.
(b) As a condition of continued enrollment, patients shall agree to:
(1) continue to receive regularly scheduled treatment for their qualifying medical condition from their health care practitioner; and
(2) report changes in their qualifying medical condition to their health care practitioner.
(c) A patient shall only receive medical cannabis from a registered manufacturer or Tribal medical cannabis program but is not required to receive medical cannabis products from only a registered manufacturer or Tribal medical cannabis program.
152.34 HEALTH CARE FACILITIES.
(a) Health care facilities licensed under chapter 144A, hospice providers licensed under chapter 144A, boarding care homes or supervised living facilities licensed under section 144.50, assisted living facilities, facilities owned, controlled, managed, or under common control with hospitals licensed under chapter 144, and other health facilities licensed by the commissioner of health, may adopt reasonable restrictions on the use of medical cannabis by a patient enrolled in the registry program who resides at or is actively receiving treatment or care at the facility. The restrictions may include a provision that the facility will not store or maintain the patient's supply of medical cannabis, that the facility is not responsible for providing the medical cannabis for patients, and that medical cannabis be used only in a place specified by the facility.
(b) Any employee or agent of a facility listed in this section or a person licensed under chapter 144E is not subject to violations under this chapter for possession of medical cannabis while carrying out employment duties, including providing or supervising care to a registered patient, or distribution of medical cannabis to a registered patient who resides at or is actively receiving treatment or care at the facility with which the employee or agent is affiliated. Nothing in this section shall require the facilities to adopt such restrictions and no facility shall unreasonably limit a patient's access to or use of medical cannabis to the extent that use is authorized by the patient under sections 152.22 to 152.37.
152.31 DATA PRACTICES.
(a) Government data in patient files maintained by the commissioner and the health care practitioner, and data submitted to or by a medical cannabis manufacturer, are private data on individuals, as defined in section 13.02, subdivision 12, or nonpublic data, as defined in section 13.02, subdivision 9, but may be used for purposes of complying with chapter 13 and complying with a request from the legislative auditor or the state auditor in the performance of official duties. The provisions of section 13.05, subdivision 11, apply to a registration agreement entered between the commissioner and a medical cannabis manufacturer under section 152.25.
(b) Not public data maintained by the commissioner may not be used for any purpose not provided for in sections 152.22 to 152.37, and may not be combined or linked in any manner with any other list, dataset, or database.
(c) The commissioner may execute data sharing arrangements with the commissioner of agriculture to verify licensing, inspection, and compliance information related to hemp growers and hemp processors under chapter 18K.
152.35 FEES; DEPOSIT OF REVENUE.
(a) The commissioner shall collect an application fee of $20,000 from each entity submitting an application for registration as a medical cannabis manufacturer. Revenue from the fee shall be deposited in the state treasury and credited to the state government special revenue fund.
(b) The commissioner shall establish and collect an annual fee from a medical cannabis manufacturer equal to the cost of regulating and inspecting the manufacturer in that year. Revenue from the fee amount shall be deposited in the state treasury and credited to the state government special revenue fund.
(c) A medical cannabis manufacturer may charge patients enrolled in the registry program a reasonable fee for costs associated with the operations of the manufacturer. The manufacturer may establish a sliding scale of patient fees based upon a patient's household income and may accept private donations to reduce patient fees.
152.37 FINANCIAL EXAMINATIONS; PRICING REVIEWS.
A medical cannabis manufacturer shall maintain detailed financial records in a manner and format approved by the commissioner, and shall keep all records updated and accessible to the commissioner when requested.
A medical cannabis manufacturer shall submit the results of an annual certified financial audit to the commissioner no later than May 1 of each year for the calendar year beginning January 2015. The annual audit shall be conducted by an independent certified public accountant and the costs of the audit are the responsibility of the medical cannabis manufacturer. Results of the audit shall be provided to the medical cannabis manufacturer and the commissioner. The commissioner may also require another audit of the medical cannabis manufacturer by a certified public accountant chosen by the commissioner with the costs of the audit paid by the medical cannabis manufacturer.
(a) The commissioner or designee may examine the business affairs and conditions of any medical cannabis manufacturer, including but not limited to a review of the financing, budgets, revenues, sales, and pricing.
(b) An examination may cover the medical cannabis manufacturer's business affairs, practices, and conditions including but not limited to a review of the financing, budgets, revenues, sales, and pricing. The commissioner shall determine the nature and scope of each examination and in doing so shall take into account all available relevant factors concerning the financial and business affairs, practices, and conditions of the examinee. The costs incurred by the department in conducting an examination shall be paid for by the medical cannabis manufacturer.
(c) When making an examination under this section, the commissioner may retain attorneys, appraisers, independent economists, independent certified public accountants, or other professionals and specialists as designees. A certified public accountant retained by the commissioner may not be the same certified public accountant providing the certified annual audit in subdivision 2.
(d) The commissioner shall make a report of an examination conducted under this section and provide a copy to the medical cannabis manufacturer. The commissioner shall then post a copy of the report on the department's website. All working papers, recorded information, documents, and copies produced by, obtained by, or disclosed to the commissioner or any other person in the course of an examination, other than the information contained in any commissioner official report, made under this section are private data on individuals or nonpublic data, as defined in section 13.02.
153.01 DEFINITIONS.
Unless the language or context clearly indicates that a different meaning is intended, the following words, terms, and phrases, for the purposes of this chapter, shall be given the meanings subjoined to them.
"Podiatric medicine" means the diagnosis or medical, mechanical, or surgical treatment of the ailments of the human hand, foot, ankle, and the soft tissue of the lower leg distal to the tibial tuberosity. Medical or surgical treatment includes partial foot amputation and excludes amputation of the hand or fingers. Use of local anesthetics is within the scope of medical and surgical management in patient care. Use of anesthetics, other than local, is excluded, except as provided in section 153.26. Podiatric medicine includes the prescribing or recommending of appliances, devices, or shoes for the correction or relief of foot ailments. Podiatric medicine includes the prescribing or administering of any drugs or medications necessary or helpful to the practice of podiatric medicine as defined by this subdivision. For a podiatrist who has completed a residency, podiatric medicine includes the performance of all or part of the medical history and physical examination for the purpose of hospital admission for podiatric management or preoperative podiatric surgery.
"Board" means the Board of Podiatric Medicine of the state of Minnesota.
MS 1986 [Repealed, 1987 c 108 s 17]
153.03 EXPENSES.
The expenses of administering Laws 1987, chapter 108, sections 1 to 16, shall be paid from the appropriations made to the board.
153.02 BOARD OF PODIATRIC MEDICINE.
The governor shall appoint a Board of Podiatric Medicine consisting of two public members as defined by section 214.02 and five resident podiatrists. The podiatrists must each hold a degree of doctor of podiatric medicine and be licensed to practice podiatric medicine under this chapter. Membership terms, compensation of members, removal of members, the filling of membership vacancies, and fiscal year and reporting requirements shall be as provided in sections 214.07 to 214.09. The provision of staff, administrative services and office space; the review and processing of complaints; the setting of board fees; and other provisions related to board operations shall be as provided in chapter 214.
The board shall elect from among its members a president and a secretary-treasurer. The board may adopt rules as necessary to carry out the purposes of this chapter. The members of the board may administer oaths and take testimony as to matters pertaining to the duties of the board. Four members of the board shall constitute a quorum for the transaction of business. The board shall have a common seal, which shall be kept by the executive director.
153.17 PRACTICING WITHOUT LICENSE; PENALTY.
It is unlawful for any person not holding a valid license or permit issued in accordance with this chapter to practice podiatric medicine as defined in section 153.01, subdivision 2, in this state.
It is unlawful for any person not holding a valid license or permit issued in accordance with this chapter to:
(1) advertise, hold out to the public, or represent in any manner that the person is authorized to practice podiatric medicine in this state;
(2) use in the conduct of any occupation or profession pertaining to the diagnosis or medical, mechanical, or surgical treatment of the ailments of the human hand, foot, ankle, or soft tissue of the lower leg distal to the tibial tuberosity, the designation "doctor of podiatric medicine," "podiatrist," "DPM," "podiatric physician," "chiropodist," "foot specialist," or "foot doctor," or uses any title, degree, letter, syllable, word, or words that would tend to lead the public to believe that person was authorized to practice or assume duties incident to the practice of podiatric medicine.
Any person violating the provisions of subdivision 1 or 2 is guilty of a gross misdemeanor.
153.18 EXEMPTIONS.
Section 153.17 does not apply to, control, prevent, or restrict the practice, service, or activities of:
(1) a person who is a commissioned medical officer of, a member of, or employed by, the armed forces of the United States, the United States Public Health Service, the Veterans Administration, any federal institution or any federal agency while engaged in the performance of official duties within this state, if the person is licensed elsewhere;
(2) a person licensed by a health-related licensing board, as defined in section 214.01, subdivision 2, or registered by the commissioner of health under section 214.13, if the person's professional activities are confined within the scope of the license;
(3) a Christian Scientist or other person who endeavors to prevent or cure disease or suffering exclusively by mental or spiritual means or by prayer.
153.21 MENTAL EXAMINATION; ACCESS TO MEDICAL DATA.
If the board has probable cause to believe that a doctor of podiatric medicine falls within the provisions of section 153.19, subdivision 1, clause (12), it may direct the doctor to submit to a mental or physical examination or substance use disorder evaluation. For the purpose of this subdivision, a doctor of podiatric medicine licensed under this chapter is considered to have consented to submit to a mental or physical examination when directed in writing by the board and further to have waived all objections to the admissibility of the examiner's testimony or examination reports on the ground that the same constitute a privileged communication. Failure of a podiatrist to submit to an examination when directed constitutes an admission of the allegations against the podiatrist, unless the failure was due to circumstance beyond the podiatrist's control, in which case a default and final order may be entered without the taking of testimony or presentation of evidence. A podiatrist affected under this subdivision shall at reasonable intervals be given an opportunity to demonstrate that the podiatrist can resume the competent practice of podiatric medicine with reasonable skill and safety to patients. In any proceeding under this subdivision, neither the record of proceedings nor the orders entered by the board shall be used against a podiatrist in any other proceeding.
In addition to ordering a physical or mental examination or substance use disorder evaluation, the board may, notwithstanding section 13.384, 144.651, or any other law limiting access to medical or other health data, obtain medical data and health records relating to a licensee or applicant without the licensee's or applicant's consent if the board has probable cause to believe that a doctor of podiatric medicine falls within the provisions of section 153.19, subdivision 1, clause (12). The medical data may be requested from a provider, as defined in section 144.291, subdivision 2, paragraph (h), an insurance company, or a government agency, including the Department of Human Services. A provider, insurance company, or government agency shall comply with any written request of the board under this section and is not liable in any action for damages for releasing the data requested by the board if the data are released in accordance with a written request under this section, unless the information is false and the provider giving the information knew, or had reason to believe, the information was false.
153.20 PODIATRIST COOPERATION.
A podiatrist who is the subject of an investigation by or on behalf of the board shall cooperate fully with the investigation. Cooperation includes responding fully and promptly to any question raised by or on behalf of the board relating to the subject of the investigation and providing copies of patient medical records, as reasonably requested by the board, to assist the board in its investigation. The board shall pay for copies requested. If the board does not have a written consent from a patient permitting access to the patient's records, the podiatrist shall delete any data in the record that identifies the patient before providing it to the board. The board shall maintain any records obtained under this section as investigative data under chapter 13.
153.23 DISCIPLINARY INVESTIGATION.
Whenever the files maintained by the board show that a podiatric medical malpractice settlement or award to the plaintiff has been made against a podiatrist as reported by insurers, the executive director may initiate a complaint under section 214.10.
The board has access to hospital and medical records of a patient treated by the podiatrist under review if the patient signs a written consent permitting that access. If no consent form has been signed, the hospital or podiatrist shall first delete data in the record that identifies the patient before providing it to the board.
153.25 IMMUNITY.
Any person, health care facility, business, or organization is immune from civil liability or criminal prosecution for submitting a report to the board under section 153.24 or for otherwise reporting to the board violations or alleged violations of section 153.19. Reports are confidential data on individuals under section 13.02, subdivision 3, and are privileged communications.
(a) Members of the board and persons employed by the board or engaged in the investigation of violations and in the preparation and management of charges of violations of this chapter on behalf of the board are immune from civil liability and criminal prosecution for any actions, transactions, or publications in the execution of, or relating to, their duties under this chapter.
(b) Members of the board and persons employed by the board or engaged in maintaining records and making reports regarding adverse health care events are immune from civil liability and criminal prosecution for any actions, transactions, or publications in the execution of or relating to their duties under section 153.255.
153.26 USE OF NITROUS OXIDE.
A podiatrist may use an oxygen-nitrous oxide mixture for sedation or analgesia only under the following conditions:
(1) the patient is not rendered unconscious;
(2) the nitrous oxide concentration is 70 percent of the mixture or less;
(3) the oxygen-nitrous oxide mixture is administered only by nasal inhalator equipped with scavenging system;
(4) an individual other than the attending podiatrist monitors the equipment and the patient during the administration of oxygen-nitrous oxide sedation and is medically directed and supervised by the podiatrist;
(5) the podiatrist and the individual referred to in clause (4) have successfully completed, after December 31, 1986, a course in nitrous oxide sedation approved by a school of podiatric medicine;
(6) the podiatrist and the individual referred to in clause (4) have completed, after December 31, 1986, a course in cardiopulmonary resuscitation;
(7) oxygen-nitrous oxide is not used in conjunction with any other analgesic or sedative; and
(8) the machine used for administering the oxygen-nitrous oxide mixture includes:
(i) an automatic shutoff valve in the event the oxygen concentration is less than three liters per minute;
(ii) an immediately available oxygen flush capability utilizing a positive pressure mask for pure oxygen delivery;
(iii) an automatic control over maximum nitrous oxide concentration which prevents oxygen concentration from falling below 30 percent of the mixture when nitrous oxide flow is maximal; and
(iv) color-coded valves, tanks, and knobs, and pin index and diameter index safety systems.
153.255 REPORTS TO COMMISSIONER OF HEALTH.
(a) The board shall maintain a record of an event that comes to the board's attention that, in the judgment of the board or a committee of the board, qualifies as an adverse health care event under section 144.7065.
(b) Within 30 days of making a determination under paragraph (a) that an event qualifies as an adverse health care event, the board shall forward to the commissioner of health a report of the event, including the facility involved, the date of the event, and information known to the board regarding the event. The report shall not include any identifying information for any of the health care professionals, facility employees, or patients involved.
153B.10 SHORT TITLE.
This chapter may be cited as the "Minnesota Orthotist, Prosthetist, and Pedorthist Practice Act."
153B.20 EXCEPTIONS.
Nothing in this chapter shall prohibit:
(1) a physician, osteopathic physician, or podiatric physician licensed by the state of Minnesota from providing services within the physician's scope of practice;
(2) a health care professional licensed by the state of Minnesota, including, but not limited to, chiropractors, physical therapists, and occupational therapy practitioners from providing services within the professional's scope of practice, or an individual working under the supervision of a licensed physician or podiatric physician;
(3) the practice of orthotics, prosthetics, or pedorthics by a person who is employed by the federal government or any bureau, division, or agency of the federal government while in the discharge of the employee's official duties;
(4) the practice of orthotics, prosthetics, or pedorthics by:
(i) a student enrolled in an accredited or approved orthotics, prosthetics, or pedorthics education program who is performing activities required by the program;
(ii) a resident enrolled in an NCOPE-accredited residency program; or
(iii) a person working in a qualified, supervised work experience or internship who is obtaining the clinical experience necessary for licensure under this chapter; or
(5) an orthotist, prosthetist, prosthetist orthotist, pedorthist, assistant, or fitter who is licensed in another state or territory of the United States or in another country that has equivalent licensure requirements as approved by the board from providing services within the professional's scope of practice subject to this chapter, if the individual is qualified and has applied for licensure under this chapter. The individual shall be allowed to practice for no longer than six months following the filing of the application for licensure, unless the individual withdraws the application for licensure or the board denies the license.
153B.25 ORTHOTICS, PROSTHETICS, AND PEDORTHICS ADVISORY COUNCIL.
(a) There is established an Orthotics, Prosthetics, and Pedorthics Advisory Council that shall consist of seven voting members appointed by the board. Five members shall be licensed and practicing orthotists, prosthetists, or pedorthists. Each profession shall be represented on the advisory council. One member shall be a Minnesota-licensed doctor of podiatric medicine who is also a member of the Board of Podiatric Medicine, and one member shall be a public member.
(b) The council shall be organized and administered under section 15.059.
The advisory council shall:
(1) advise the board on enforcement of the provisions contained in this chapter;
(2) review reports of investigations or complaints relating to individuals and make recommendations to the board as to whether a license should be denied or disciplinary action taken against an individual;
(3) advise the board regarding standards for licensure of professionals under this chapter; and
(4) perform other duties authorized for advisory councils by chapter 214, as directed by the board.
The council must elect a chair from among its members.
The Board of Podiatric Medicine must provide meeting space and administrative services for the council.
153B.30 LICENSURE.
An application for a license shall be submitted to the board in the format required by the board and shall be accompanied by the required fee, which is nonrefundable.
(a) To be eligible for licensure as an orthotist, prosthetist, or prosthetist orthotist, an applicant shall meet orthotist, prosthetist, or prosthetist orthotist certification requirements of either the American Board for Certification in Orthotics, Prosthetics, and Pedorthics or the Board of Certification/Accreditation in effect at the time of the individual's application for licensure and be in good standing with the certifying board.
(b) To be eligible for licensure as a pedorthist, an applicant shall meet the pedorthist certification requirements of either the American Board for Certification in Orthotics, Prosthetics, and Pedorthics or the Board of Certification/Accreditation that are in effect at the time of the individual's application for licensure and be in good standing with the certifying board.
(c) To be eligible for licensure as an orthotic or prosthetic assistant, an applicant shall meet the orthotic or prosthetic assistant certification requirements of the American Board for Certification in Orthotics, Prosthetics, and Pedorthics that are in effect at the time of the individual's application for licensure and be in good standing with the certifying board.
(d) To be eligible for licensure as an orthotic fitter, an applicant shall meet the orthotic fitter certification requirements of either the American Board for Certification in Orthotics, Prosthetics, and Pedorthics or the Board of Certification/Accreditation that are in effect at the time of the individual's application for licensure and be in good standing with the certifying board.
A license to practice is valid for a term of up to 24 months beginning on January 1 or commencing after initially fulfilling the license requirements and ending on December 31 of the following year.
153A.13 DEFINITIONS.
The definitions in this section apply to sections 153A.13 to 153A.18.
"Commissioner" means the commissioner of the Department of Health or a designee.
"Hearing aid " means an instrument as defined in section 148.512, subdivision 10a.
"Hearing aid dispensing" has the meaning given in section 148.512, subdivision 10b.
"Dispenser of hearing aids " means a natural person who engages in prescription hearing aid dispensing, whether or not certified by the commissioner of health or licensed by an existing health-related board, except that a person described as follows is not a dispenser of prescription hearing aids:
(1) a student participating in supervised field work that is necessary to meet requirements of an accredited educational program if the student is designated by a title which clearly indicates the student's status as a student trainee; or
(2) a person who helps a dispenser of prescription hearing aids in an administrative or clerical manner and does not engage in prescription hearing aid dispensing.
A person who offers to dispense a prescription hearing aid, or a person who advertises, holds out to the public, or otherwise represents that the person is authorized to dispense prescription hearing aids, must be certified by the commissioner except when the person is an audiologist as defined in section 148.512.
"Advisory council" means the Minnesota Hearing Aid Dispenser Advisory Council, or a committee of the council, established under section 153A.20.
"ANSI" means American National Standard Specification for Audiometers as defined in the United States Food and Drug Administration, Code of Federal Regulations, title 21, section 874.1050.
"Certification number" means the number assigned to each certification by the commissioner.
"Supervision" means monitoring activities of, and accepting responsibility for, the prescription hearing aid dispensing activities of a trainee.
"Direct supervision" or "directly supervised" means the on-site and contemporaneous location of a supervisor and trainee, when the supervisor observes the trainee engaging in prescription hearing aid dispensing with a consumer.
"Indirect supervision" or "indirectly supervised" means the remote and independent performance of prescription hearing aid dispensing by a trainee when authorized under section 153A.14, subdivision 4a, paragraph (b).
"Over-the-counter hearing aid" or "OTC hearing aid" has the meaning given in section 148.512, subdivision 10c.
"Prescription hearing aid" has the meaning given in section 148.512, subdivision 13a.
153B.35 EMPLOYMENT BY AN ACCREDITED FACILITY; SCOPE OF PRACTICE.
A licensed orthotist, prosthetist, pedorthist, assistant, or orthotic fitter may provide limited, supervised orthotic or prosthetic patient care services beyond their licensed scope of practice if all of the following conditions are met:
(1) the licensee is employed by a patient care facility that is accredited by a national accrediting organization in orthotics, prosthetics, and pedorthics;
(2) written objective criteria are documented by the accredited facility to describe the knowledge and skills required by the licensee to demonstrate competency to provide additional specific and limited orthotic or prosthetic patient care services that are outside the licensee's scope of practice;
(3) the licensee provides orthotic or prosthetic patient care only at the direction of a supervisor who is licensed as an orthotist, pedorthist, or prosthetist who is employed by the facility to provide the specific orthotic or prosthetic patient care or services that are outside the licensee's scope of practice; and
(4) the supervised orthotic or prosthetic patient care occurs in compliance with facility accreditation standards.