reglab/housing_qa huggingface dataset:
MD. Health - General Code Ann. §  21-2A-04.1 (2021)
2021 Maryland Statutes|Health - General|Title 21 - Food, Drugs, and Cosmetics|Subtitle 2A - Prescription Drug Monitoring Program|Section 21-2A-04.1 - Registration of Prescribers With Program

    (a)    A prescriber shall be registered with the Program before obtaining a new or renewal registration with the Department under § 5–304(a) of the Criminal Law Article or by July 1, 2017, whichever is sooner.    (b)    A pharmacist shall be registered with the Program by July 1, 2017.    (c)    Before registering with the Program, a prescriber and a pharmacist shall complete a course of instruction and training developed by the Department, including the effective use of the Program.
MD. Health - General Code Ann. §  21-2A-04.3 (2021)
2021 Maryland Statutes|Health - General|Title 21 - Food, Drugs, and Cosmetics|Subtitle 2A - Prescription Drug Monitoring Program|Section 21-2A-04.3 - Authorization of Prescriber Delegate or Pharmacist Delegate to Request Prescription Monitoring Data

    A prescriber or pharmacist may authorize a prescriber delegate or pharmacist delegate to request prescription monitoring data on behalf of the prescriber or pharmacist if:        (1)    The prescriber or pharmacist takes reasonable steps to ensure that the prescriber delegate or pharmacist delegate is competent in the use of the Program;        (2)    The prescriber or pharmacist remains responsible for:            (i)    Ensuring that access to the Program by the prescriber delegate or pharmacist delegate is limited to purposes authorized by law;            (ii)    Protecting the confidentiality of the prescription monitoring data; and            (iii)    Any breach of confidentiality by the prescriber delegate or pharmacist delegate; and        (3)    The decision whether to prescribe or dispense a monitored prescription drug for a patient:            (i)    Remains with the prescriber or pharmacist; and            (ii)    Is reasonably informed by the prescription monitoring data obtained from the Program.
MD. Health - General Code Ann. §  21-2A-07 (2021)
2021 Maryland Statutes|Health - General|Title 21 - Food, Drugs, and Cosmetics|Subtitle 2A - Prescription Drug Monitoring Program|Section 21-2A-07 - Technical Advisory Committee

    (a)    There is a technical advisory committee to the Program.    (b)    The purpose of the technical advisory committee is to:        (1)    Review requests for information from the Program under § 21–2A–06(b)(3), (4), (5), (6), (8), or (9) of this subtitle; and        (2)    Provide clinical guidance and interpretation to the Program regarding indications of possible misuse or abuse of a monitored prescription drug or a possible violation of law or a possible breach of professional standards by a prescriber or a dispenser under § 21–2A–06(c) and (d) of this subtitle.    (c)    The technical advisory committee consists of members appointed by the Secretary, including:        (1)    A board certified anesthesiologist licensed and practicing in the State, nominated by the Maryland Society of Anesthesiologists;        (2)    A certified addiction medicine specialist licensed and practicing in the State, nominated by the Maryland Society for Addiction Medicine;        (3)    A pharmacist licensed and practicing in the State;        (4)    A medical professional, licensed and practicing in the State, who is treating cancer patients;        (5)    A board certified physician specializing in the treatment of patients with pain, licensed and practicing in the State, nominated by the Maryland Society of Physical Medicine and Rehabilitation;        (6)    Two medical professionals, licensed and practicing in the State with expertise or experience in providing care for patients with substance–related or mental health disorders;        (7)    A dentist licensed and practicing in the State; and        (8)    A medical professional licensed and practicing in the State in the field of internal medicine or family practice.
MD. Health - General Code Ann. §  21-2A-08 (2021)
2021 Maryland Statutes|Health - General|Title 21 - Food, Drugs, and Cosmetics|Subtitle 2A - Prescription Drug Monitoring Program|Section 21-2A-08 - Liability

    (a)    With respect to the administration and operation of the Program, the Department and its agents and employees are not subject to liability arising from:        (1)    The inaccuracy of any information submitted to the Program in accordance with this subtitle; or        (2)    The unauthorized use or disclosure of prescription monitoring data by a person to whom the Program was authorized to provide the prescription monitoring data under this subtitle.    (b)    Except as provided in § 21–2A–09(b)(3) of this subtitle, a prescriber, prescriber delegate, pharmacist, or pharmacist delegate, acting in good faith, is not subject to liability or disciplinary action arising solely from:        (1)    Requesting or receiving, or failing to request or receive, prescription monitoring data from the Program; or        (2)    Acting, or failing to act, on the basis of prescription monitoring data provided by the Program.
MD. Health - General Code Ann. §  21-2A-09 (2021)
2021 Maryland Statutes|Health - General|Title 21 - Food, Drugs, and Cosmetics|Subtitle 2A - Prescription Drug Monitoring Program|Section 21-2A-09 - Violations

    (a)    A dispenser who knowingly fails to submit prescription monitoring data to the Program as required under this subtitle shall be subject to a civil penalty not exceeding $500 for each failure to submit required information.    (b)    (1)    A person who knowingly discloses, uses, obtains, or attempts to obtain by fraud or deceit, prescription monitoring data in violation of this subtitle shall be guilty of a misdemeanor and on conviction is subject to imprisonment not exceeding 1 year or a fine not exceeding $10,000 or both.        (2)    In addition to the penalties under paragraph (1) of this subsection, a prescriber, prescriber delegate, pharmacist, or pharmacist delegate who knowingly discloses or uses prescription monitoring data in violation of this subtitle shall be subject to disciplinary action by the appropriate licensing entity.        (3)    A prescriber or pharmacist who violates § 21–2A–04.1 or § 21–2A–04.2 of this subtitle shall be subject to disciplinary action by the appropriate licensing entity.        (4)    The release of prescription monitoring data by a prescriber, prescriber delegate, pharmacist, or pharmacist delegate to a licensed health care professional solely for treatment purposes in a manner otherwise consistent with State and federal law is not a violation of this subtitle.
MD. Health - General Code Ann. §  21-2B-02 (2021)
2021 Maryland Statutes|Health - General|Title 21 - Food, Drugs, and Cosmetics|Subtitle 2B - Right to Try Act|Section 21-2B-02 - Providing Investigational Drug, Biological Product, or Device

    (a)    A manufacturer of an investigational drug, biological product, or device may:        (1)    Provide the manufacturer’s investigational drug, biological product, or device to an eligible patient without compensation; or        (2)    Subject to subsection (b) of this section, require an eligible patient to pay the costs of or associated with the manufacture of the investigational drug, biological product, or device provided to the eligible patient.    (b)    (1)    Any payment required by a manufacturer under subsection (a)(2) of this section shall be limited to the recovery of the costs of or associated with the manufacture of the specific investigational drug or biological product dosages or devices provided to the eligible patient.        (2)    A manufacturer of an investigational drug, biological product, or device may not profit from providing an investigational drug, biological product, or device provided to an eligible patient.    (c)    After the date that an eligible patient begins taking or using the investigational drug, biological product, or device and during the time the eligible patient is taking or using the investigational drug, biological product, or device, the manufacturer shall notify the eligible patient and the eligible patient’s health care provider of any side effects or risks associated with the investigational drug, biological product, or device that are required to be disclosed to the United States Food and Drug Administration during the drug approval process.    (d)    (1)    The Office of the Attorney General shall develop an informed consent form that:            (i)    Complies with the requirements of  § 21–2B–01(e)(3) of this subtitle;            (ii)    Includes instructions for the physician or patient on how to complete the form; and            (iii)    Provides spaces for a physician to include the information relating to a particular patient and the physician’s recommendation for the patient.        (2)    This subsection may not be construed to prohibit a treating physician or a manufacturer of an investigational drug, biological product, or device from including additional information or advisements with the informed consent form developed under paragraph (1) of this subsection.
MD. Health - General Code Ann. §  21-2B-03 (2021)
2021 Maryland Statutes|Health - General|Title 21 - Food, Drugs, and Cosmetics|Subtitle 2B - Right to Try Act|Section 21-2B-03 - Actions Prohibited if Based on Recommendation Regarding Access to or Treatment With an Investigational Drug, Biological Product, or Device

    (a)    A health occupations board may not revoke, fail to renew, suspend, or take any action against a health care provider’s license based solely on the health care provider’s recommendation to an eligible patient regarding access to or treatment with an investigational drug, biological product, or device.    (b)    The Department may not take action against a health care provider’s Medicare certification based solely on the health care provider’s recommendation that an eligible patient have access to an investigational drug, biological product, or device or the health care provider’s treatment of an eligible patient with an investigational drug, biological product, or device.
MD. Health - General Code Ann. §  21-2B-04 (2021)
2021 Maryland Statutes|Health - General|Title 21 - Food, Drugs, and Cosmetics|Subtitle 2B - Right to Try Act|Section 21-2B-04 - Blocking Access by Official, Employee, or Agent of the State Prohibited

    (a)    An official, employee, or agent of the State may not block or attempt to block an eligible patient’s access to an investigational drug, biological product, or device.    (b)    This section does not prohibit a licensed health care provider from providing counsel, advice, or a recommendation that is consistent with medical standards of care.
MD. Health - General Code Ann. §  21-2B-05 (2021)
2021 Maryland Statutes|Health - General|Title 21 - Food, Drugs, and Cosmetics|Subtitle 2B - Right to Try Act|Section 21-2B-05 - Private Cause of Action Not Created

    This subtitle does not create a private cause of action against a manufacturer of an investigational drug, biological product, or device or against another person involved in the care of an eligible patient using the investigational drug, biological product, or device for any harm to the eligible patient resulting from the investigational drug, biological product, or device if the manufacturer or other person is complying in good faith with this subtitle and has exercised reasonable care.
MD. Health - General Code Ann. §  21-2B-06 (2021)
2021 Maryland Statutes|Health - General|Title 21 - Food, Drugs, and Cosmetics|Subtitle 2B - Right to Try Act|Section 21-2B-06 - Health Insurance Coverage Not Affected

    This subtitle does not affect the coverage requirements under Title 15, Subtitle 8 of the Insurance Article.
MD. Health - General Code Ann. §  21-2C-01 (2021)
2021 Maryland Statutes|Health - General|Title 21 - Food, Drugs, and Cosmetics|Subtitle 2C - Prescription Drug Affordability Board|Section 21-2C-01 - Definitions

    (a)    In this subtitle the following words have the meanings indicated.    (b)    “Biologic” means a drug that is produced or distributed in accordance with a biologics license application approved under 42 C.F.R. § 447.502.    (c)    “Biosimilar” means a drug that is produced or distributed in accordance with a biologics license application approved under 42 U.S.C. § 262(k)(3).    (d)    “Board” means the Prescription Drug Affordability Board.    (e)    (1)    “Brand name drug” means a drug that is produced or distributed in accordance with an original new drug application approved under 21 U.S.C. § 355(c).        (2)    “Brand name drug” does not include an authorized generic as defined by 42 C.F.R. § 447.502.    (f)    “Generic drug” means:        (1)    A retail drug that is marketed or distributed in accordance with an abbreviated new drug application, approved under 21 U.S.C. § 355(j);        (2)    An authorized generic as defined by 42 C.F.R. § 447.502; or        (3)    A drug that entered the market before 1962 that was not originally marketed under a new drug application.    (g)    “Manufacturer” means an entity that:        (1)    (i)    Engages in the manufacture of a prescription drug product; or            (ii)    Enters into a lease with another manufacturer to market and distribute a prescription drug product under the entity’s own name; and        (2)    Sets or changes the wholesale acquisition cost of the prescription drug product it manufactures or markets.    (h)    “Prescription drug product” means a brand name drug, a generic drug, a biologic, or a biosimilar.    (i)    “Stakeholder Council” means the Prescription Drug Affordability Stakeholder Council.
MD. Health - General Code Ann. §  21-2C-02 (2021)
2021 Maryland Statutes|Health - General|Title 21 - Food, Drugs, and Cosmetics|Subtitle 2C - Prescription Drug Affordability Board|Section 21-2C-02 - Prescription Drug Affordability Board

    (a)    (1)    There is a Prescription Drug Affordability Board.        (2)    (i)    The Board is a body politic and corporate and is an instrumentality of the State.            (ii)    The Board is an independent unit of State government.            (iii)    The exercise by the Board of its authority under this subtitle is an essential governmental function.    (b)    The purpose of the Board is to protect State residents, State and local governments, commercial health plans, health care providers, pharmacies licensed in the State, and other stakeholders within the health care system from the high costs of prescription drug products.
MD. Health - General Code Ann. §  21-2C-05 (2021)
2021 Maryland Statutes|Health - General|Title 21 - Food, Drugs, and Cosmetics|Subtitle 2C - Prescription Drug Affordability Board|Section 21-2C-05 - Disclosure of Conflicts of Interest

    (a)    (1)    A conflict of interest shall be disclosed:            (i)    By the Board when hiring Board staff;            (ii)    By the appointing authority when appointing members and alternate members to the Board and members to the Stakeholder Council; and            (iii)    By the Board, when a member of the Board is recused in any final decision resulting from a review of a prescription drug product.        (2)    A conflict of interest shall be disclosed:            (i)    In advance of the first open meeting after the conflict is identified; or            (ii)    Within 5 days after the conflict is identified.    (b)    (1)    A conflict of interest disclosed under subsection (a) of this section shall be posted on the website of the Board unless the chair of the Board recuses the member from any final decision resulting from a review of a prescription drug product.        (2)    A posting under paragraph (1) of this subsection shall include the type, nature, and magnitude of the interests of the member involved.
MD. Health - General Code Ann. §  21-2C-06 (2021)
2021 Maryland Statutes|Health - General|Title 21 - Food, Drugs, and Cosmetics|Subtitle 2C - Prescription Drug Affordability Board|Section 21-2C-06 - Acceptance of Gratuities Prohibited

    Members and alternate members of the Board, Board staff, and third–party contractors may not accept any gift or donation of services or property that indicates a potential conflict of interest or has the appearance of biasing the work of the Board.
MD. Health - General Code Ann. §  21-2C-07 (2021)
2021 Maryland Statutes|Health - General|Title 21 - Food, Drugs, and Cosmetics|Subtitle 2C - Prescription Drug Affordability Board|Section 21-2C-07 - Study and Report -- Pharmaceutical Distribution and Payment System in State; Policy Options Used in Other States and Countries

    On or before December 31, 2021, the Board, in consultation with the Stakeholder Council, shall:        (1)    Study:            (i)    The entire pharmaceutical distribution and payment system in the State; and            (ii)    Policy options being used in other states and countries to lower the list price of pharmaceuticals, including:                1.    Setting upper payment limits;                2.    Using a reverse auction marketplace; and                3.    Implementing a bulk purchasing process; and        (2)    Report its findings and recommendations, including findings for each option studied under item (1)(ii) of this section and any legislation required to implement the recommendations, to the Senate Finance Committee and the House Health and Government Operations Committee in accordance with § 2–1257 of the State Government Article.
MD. Health - General Code Ann. §  21-2C-10 (2021)
2021 Maryland Statutes|Health - General|Title 21 - Food, Drugs, and Cosmetics|Subtitle 2C - Prescription Drug Affordability Board|Section 21-2C-10 - Confidentiality

    (a)    All information and data obtained by the Board under this subtitle, that is not otherwise publicly available:        (1)    Is considered to be a trade secret and confidential and proprietary information; and        (2)    Is not subject to disclosure under the Public Information Act.    (b)    Only Board members and staff may access trade secrets and confidential and proprietary data and information obtained under this subtitle that is not otherwise publicly available.    (c)    The provisions of Title 11, Subtitle 12 of the Commercial Law Article shall apply to any trade secrets and confidential and proprietary data and information obtained under this subtitle that is not otherwise publicly available.
MD. Health - General Code Ann. §  21-2C-11 (2021)
2021 Maryland Statutes|Health - General|Title 21 - Food, Drugs, and Cosmetics|Subtitle 2C - Prescription Drug Affordability Board|Section 21-2C-11 - Funding Source

    (a)    On or before December 31, 2020, the Board shall determine a funding source for the Board.    (b)    In determining a funding source, the Board shall consider:        (1)    Assessing and collecting a fee on manufacturers, pharmacy benefits managers, health insurance carriers, wholesale distributors, or other entities;        (2)    Using rebates the State or local government receives from manufacturers; and        (3)    Any other method it determines appropriate for funding the Board.    (c)    On or before December 31, 2020, in accordance with § 2–1257 of the State Government Article, the Board shall report back to the Senate Finance Committee and the House Health and Government Operations Committee with a recommendation on legislation necessary to establish a funding source for the Board.    (d)    The Board shall be established using general funds, which shall be repaid to the State with the funds from the funding source determined by the Board under subsection (a) of this section.
MD. Health - General Code Ann. §  21-2C-12 (2021)
2021 Maryland Statutes|Health - General|Title 21 - Food, Drugs, and Cosmetics|Subtitle 2C - Prescription Drug Affordability Board|Section 21-2C-12 - Enforcement

    The Office of the Attorney General may pursue any available remedy under State law when enforcing this subtitle.
MD. Health - General Code Ann. §  21-2C-13 (2021)
2021 Maryland Statutes|Health - General|Title 21 - Food, Drugs, and Cosmetics|Subtitle 2C - Prescription Drug Affordability Board|Section 21-2C-13 - Drafting Action Plan for Implementing Process to Set Upper Payment Limits for Prescription Drug Products

    (a)    On or after January 1, 2022, the Board may set upper payment limits for prescription drug products that are:        (1)    Purchased or paid for by a unit of State or local government or an organization on behalf of a unit of State or local government, including:            (i)    State or county correctional facilities;            (ii)    State hospitals; and            (iii)    Health clinics at State institutions of higher education;        (2)    Paid for through a health benefit plan on behalf of a unit of State or local government, including a county, bicounty, or municipal employee health benefit plan; or        (3)    Purchased for or paid for by the Maryland State Medical Assistance Program.    (b)    The upper payment limits set under subsection (a) of this section shall:        (1)    Be for prescription drug products that have led or will lead to an affordability challenge; and        (2)    Be set in accordance with the criteria established in regulations adopted by the Board.    (c)    (1)    The Board shall:            (i)    Monitor the availability of any prescription drug product for which it sets an upper payment limit; and            (ii)    If there becomes a shortage of the prescription drug product in the State, reconsider whether the upper payment limit should be suspended or altered.        (2)    An upper payment limit set under subsection (a) of this section may not be applied to a prescription drug product while the prescription drug product is on the federal Food and Drug Administration prescription drug shortage list.
MD. Health - General Code Ann. §  21-2C-14 (2021)
2021 Maryland Statutes|Health - General|Title 21 - Food, Drugs, and Cosmetics|Subtitle 2C - Prescription Drug Affordability Board|Section 21-2C-14 - Setting Upper Payment Limits for Prescription Drug Products

    (a)    On or after January 1, 2022, the Board, in accordance with the plan of action approved under § 21–2C–13 of this subtitle, may set upper payment limits for prescription drug products that are:        (1)    Purchased or paid for by a unit of State or local government or an organization on behalf of a unit of State or local government, including:            (i)    State or county correctional facilities;            (ii)    State hospitals; and            (iii)    Health clinics at State institutions of higher education;        (2)    Paid for through a health benefit plan on behalf of a unit of State or local government, including a county, bicounty, or municipal employee health benefit plan; or        (3)    Purchased for or paid for by the Maryland State Medical Assistance Program.    (b)    The upper payment limits set under subsection (a) of this section shall:        (1)    Be for prescription drug products that have led or will lead to an affordability challenge; and        (2)    Be set in accordance with the criteria established in regulations adopted by the Board.    (c)    (1)    The Board shall:            (i)    Monitor the availability of any prescription drug product for which it sets an upper payment limit; and            (ii)    If there becomes a shortage of the prescription drug product in the State, reconsider whether the upper payment limit should be suspended or altered.        (2)    An upper payment limit set under subsection (a) of this section may not be applied to a prescription drug product while the prescription drug product is on the federal Food and Drug Administration prescription drug shortage list.