reglab/statecodes huggingface dataset:
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part VI - Enforcement of Subtitle; Prohibited Acts › Section 21-254 - Action Against Food That Poses Immediate Threat

(a)    (1)    For purposes of this section, an “immediate threat” exists if any meat, seafood, poultry, vegetable, fruit, or any other perishable substance that is intended for consumption as food:
(i)    Contains any filthy, decomposed, or putrid substance;
(ii)    Is poisonous or otherwise would be injurious to health if consumed; or
(iii)    Is otherwise unsafe.
(2)    If a food poses an immediate threat, it shall be considered a public nuisance.
(b)    If the Secretary finds that a food poses an immediate threat, the Secretary immediately shall destroy the food or otherwise make the food unusable for consumption by human beings.
(c)    The owner of a substance that is destroyed or otherwise made unusable under this section may bring a suit for damages against the Secretary.
(d)    The Secretary shall have the immunity from liability described under § 5-633 of the Courts and Judicial Proceedings Article.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part VI - Enforcement of Subtitle; Prohibited Acts › Section 21-255 - Reporting of Criminal Violations

(a)    Except as otherwise provided in this section, the Secretary shall report to the State’s Attorney any alleged criminal violation of this subtitle.
(b)    Before the Secretary reports any alleged violation of this subtitle to a State’s Attorney for the institution of a criminal proceeding, the Secretary shall give the alleged violator notice and an opportunity to present that person’s views to the Secretary either orally or in writing. The views of the alleged violator may be presented by counsel.
(c)    If the Secretary believes that there has been a violation of this subtitle, but that the violation was minor and the public interest would be served adequately in the circumstances by a written notice or warning, the Secretary may issue a written notice or warning instead of reporting the violation to the State’s Attorney.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part VI - Enforcement of Subtitle; Prohibited Acts › Section 21-256 - Prohibited Acts -- General Provisions

A person may not:
(1)    Manufacture or sell any food, drug, device, or cosmetic that is adulterated or misbranded;
(2)    Adulterate or misbrand any food, drug, device, or cosmetic;
(3)    Make a food, drug, device, or cosmetic become adulterated by altering, mutilating, destroying, obliterating, or removing any part of its labeling while the food, drug, device, or cosmetic is held for sale;
(4)    Receive in commerce any adulterated or misbranded food, drug, device, or cosmetic;
(5)    Deliver or offer for delivery any adulterated or misbranded food, drug, device, or cosmetic, whether or not for pay;
(6)    Disseminate any false advertisement;
(7)    Sell any food in violation of any requirement imposed under § 21-211 of this subtitle;
(8)    Fail to comply with § 21-249 or § 21-250 of this subtitle by refusing to permit:
(i)    An entry or inspection;
(ii)    The taking of a sample; or
(iii)    Access to or copying of any record;
(9)    Remove or dispose of any article that is detained or restricted under § 21-253 of this subtitle; or
(10)    Forge, counterfeit, simulate, falsely represent, or, without proper authority, use any mark, stamp, tag, label, or other identifying symbol that is authorized or required by any rule or regulation that is adopted under the provisions of the federal act or of this subtitle.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part VI - Enforcement of Subtitle; Prohibited Acts › Section 21-257 - Violation of Label and Packaging Requirements for Consumer Commodities

(a)    Except to the extent that the person is engaged in the packing or labeling of the commodity or specifies, by any means, the manner in which the commodity is packed or labeled, this section does not apply to any person who is engaged in business as a wholesale or retail distributor of a consumer commodity.
(b)    A person may not distribute a consumer commodity in commerce if:
(1)    The commodity is contained in a package that does not conform to a requirement that is imposed under this subtitle; or
(2)    A label that does not conform to a requirement imposed under this subtitle is attached to the commodity.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part VI - Enforcement of Subtitle; Prohibited Acts › Section 21-258 - Prohibited Acts -- Drugs and Devices

(a)    In this section, “counterfeit marking tool” means any punch, die, plate, stone, or other thing that is designed to print, imprint, or otherwise reproduce the trademark, trade name, imprint, symbol, or any other identifying mark of a drug, or a likeness of any of these markings, on a drug or on the container of a drug, other than the drug or container to which the marking belongs.
(b)    A person may not:
(1)    Sell any new drug in violation of § 21-223 of this subtitle;
(2)    On the labeling of any drug or in any advertisement relating to the drug, use any representation or suggestion that an application as to the drug is effective under § 21-223 of this subtitle, or that the drug complies with that section;
(3)    Fail to maintain and to provide to a health practitioner on request printed matter that relates to prescription drugs, as required under § 21-226 of this subtitle;
(4)    Place or cause to be placed on any drug or device or on its container, with intent to defraud, the trade name, imprint, or other identifying mark of any other drug or any likeness of any of these markings;
(5)    With knowledge that the trade name, imprint, or other identifying mark of another drug, or any likeness of any of these markings has been placed on a drug or device or its container in violation of item (4) of this subsection:
(i)    Sell, dispense, or dispose of the drug or device or its container;
(ii)    Cause the drug or device or its container to be sold, dispensed, or disposed of; or
(iii)    Conceal or keep possession, control, or custody of the drug or device or its container with intent to sell, dispense, or dispose of it;
(6)    Make, sell, or dispose of any counterfeit marking tool;
(7)    Cause any counterfeit marking tool to be made, sold, or disposed of;
(8)    Keep possession, control, or custody of any counterfeit marking tool;
(9)    Conceal any counterfeit marking tool;
(10)    Cause a drug to be a counterfeit drug;
(11)    Sell or dispense a counterfeit drug or hold a counterfeit drug for sale or dispensing;
(12)    Except as permitted under § 12-504 of the Health Occupations Article, dispense or cause to be dispensed, without the permission of the prescriber, a different drug or brand of drug instead of the drug or brand of drug prescribed;
(13)    Prescribe any drug on a written prescription form without clearly identifying the name of the prescriber;
(14)    Dispense any drug based on a prescription form that lacks the prescriber’s name and signature which:
(i)    May not be made by use of a rubber stamp; but
(ii)    Except as otherwise required by State law for a controlled dangerous substance, is not required for oral prescription orders; or
(15)    Fail to provide to the Secretary on request information about prescription drugs, as required under § 21-227 of this subtitle.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part VI - Enforcement of Subtitle; Prohibited Acts › Section 21-259 - Prohibited Acts -- False Reports; Misuse of Information

A person may not:
(1)    Make a written report that falsely certifies the results of any inspection, examination, or test that is made to determine if there is a violation of any provision of this part;
(2)    Use to that person’s own personal advantage any information that is acquired under authority of this subtitle and concerns any method or process that is entitled to protection as a trade secret; or
(3)    Other than to the Secretary, to the Secretary’s authorized representative, or to a court in a judicial proceeding under this subtitle, reveal any information that:
(i)    Is acquired under authority of this subtitle; and
(ii)    Concerns any method or process that is entitled to protection as a trade secret.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part VI - Enforcement of Subtitle; Prohibited Acts › Section 21-259.1 - Prohibited Acts -- Opening Closed Food Container

(a)    A person may not open a sealed, closed, or fastened food container in a food store or supermarket if opening the package or container will leave the item in an unsalable condition, unless the person:
(1)    Intends to purchase the item; or
(2)    Has received from the proprietor authority to open the item.
(b)    A person who violates this section is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $25.
(c)    The penalty provisions of Subtitle 12 of this title do not apply to this section.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part VI - Enforcement of Subtitle; Prohibited Acts › Section 21-259.2 - Prohibition on Certain Ingredients Knowingly Included in Cosmetic Products. [Effective January 1, 2025]

** TAKES EFFECT JANUARY 1, 2025 PER CHAPTER 490 OF 2021 **
(a)    In this section:
(1)    “Ingredient” means any single chemical entity or mixture used as a component in the manufacture of a cosmetic product; and
(2)    “Ingredient” does not include an incidental ingredient, as described in 21 C.F.R. § 701.3(l).
(b)    Except as provided in subsection (c) of this section, a person may not knowingly manufacture, sell, deliver, hold, or offer for sale in the State a cosmetic product that contains any of the following intentionally added ingredients:
(1)    Dibutyl phthalate (CAS no. 84–74–2);
(2)    Diethylhexyl phthalate (CAS no. 117–81–7);
(3)    Formaldehyde (CAS no. 50–00–0);
(4)    Paraformaldehyde (CAS no. 30525–89–4);
(5)    Methylene glycol (CAS no. 463–57–0);
(6)    Quaternium–15 (CAS no. 51229–78–8);
(7)    Mercury (CAS no. 7439–97–6);
(8)    Isobutylparaben (CAS no. 4247–02–3);
(9)    Isopropylparaben (CAS no. 4191–73–5);
(10)    m–Phenylenediamine and its salts (CAS no. 108–45–2);
(11)    o–Phenylenediamine and its salts (CAS no. 95–54–5); or
(12)    The following per– and polyfluoroalkyl substances (PFAS) and their salts:
(i)    Perfluorooctane sulfonate (PFOS) or heptadecafluorooctane–1–sulfonic acid (CAS no. 1763–23–1);
(ii)    Potassium perfluorooctanesulfonate or potassium heptadecafluorooctane–1–sulfonate (CAS no. 2795–39–3);
(iii)    Diethanolamine perfluorooctane sulfonate (CAS no. 70225–14–8);
(iv)    Ammonium perfluorooctane sulfonate or ammonium heptadecafluorooctanesulfonate (CAS no. 29081–56–9);
(v)    Lithium perfluorooctane sulfonate or lithium heptadecafluorooctanesulfonate (CAS no. 29457–72–5);
(vi)    Perfluorooctanoic acid (PFOA) (CAS no. 335–67–1);
(vii)    Ammonium pentadecafluorooctanoate (CAS no. 3825–26–1);
(viii)    Nonadecafluorodecanoic acid (CAS no. 335–76–2);
(ix)    Ammonium nonadecafluorodecanoate (CAS no. 3108–42–7);
(x)    Sodium nonadecafluorodecanoate (CAS no. 3830–45–3);
(xi)    Perfluorononanoic acid (PFNA) (CAS no. 375–95–1);
(xii)    Sodium heptadecafluorononanoate (CAS no. 21049–39–8); or
(xiii)    Ammonium perfluorononanoate (CAS no. 4149–60–4).
(c)    A person is not in violation of this section if the person manufactures, sells, delivers, holds, or offers for sale in the State a cosmetic product that:
(1)    Was manufactured through a process intended to comply with this section; and
(2)    Contains a technically unavoidable trace quantity of an ingredient listed in subsection (b) of this section due to:
(i)    An impurity of a natural or synthetic ingredient;
(ii)    The manufacturing process;
(iii)    Storage; or
(iv)    Packaging.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part VI - Enforcement of Subtitle; Prohibited Acts › Section 21-261 - Abatement Orders

(a)    If the Department believes that a person is violating any provision of this subtitle or any regulation adopted under this subtitle, the Department may have the person served with a written order that directs the person served to abate the violation within a time specified in the order.
(b)    Except as otherwise provided in the Administrative Procedure Act, the Department shall give any person served with an order under this section an opportunity for a hearing before the Department.
(c)    After a hearing under this section, the Department may affirm, modify, or withdraw the order.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2A - Prescription Drug Monitoring Program › Section 21-2A-02 - Program

(a)    There is a Prescription Drug Monitoring Program in the Department.
(b)    The mission of the Program is to:
(1)    Assist prescribers, pharmacists, and public health professionals in:
(i)    The identification and prevention of prescription drug abuse; and
(ii)    The identification and investigation of unlawful prescription drug diversion; and
(2)    Promote a balanced use of prescription monitoring data to assist appropriate law enforcement activities while preserving the professional practice of health care providers and the access of patients to optimal pharmaceutical care.
(c)    To carry out its mission, the Program shall monitor the prescribing and dispensing of all Schedule II, Schedule III, Schedule IV, and Schedule V controlled dangerous substances and the dispensing of naloxone medication by all prescribers and dispensers in the State.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2A - Prescription Drug Monitoring Program › Section 21-2A-03 - Implementation and Operation; Prescription Monitoring Data

(a)    The Department shall implement the Program, subject to the availability of funds.
(b)    The Secretary may:
(1)    Assign responsibility for the operation of the Program to any unit in the Department;
(2)    Contract with any qualified person for the efficient and economical operation of the Program; and
(3)    Identify and publish a list of monitored prescription drugs that have a low potential for abuse by individuals.
(c)    Except as provided in subsection (d) of this section, each dispenser shall submit prescription monitoring data and naloxone medication data to the Program by electronic means, in accordance with regulations adopted by the Secretary.
(d)    The Secretary, for good cause shown, may authorize a dispenser to submit prescription monitoring data or naloxone medication data by an alternative form of submission.
(e)    The Secretary, in consultation with the Maryland Health Care Commission and the Board, shall:
(1)    Determine the appropriate technology to support the operation of the Program; and
(2)    Educate dispensers, prescribers, pharmacists, prescriber delegates, pharmacist delegates, and consumers about the purpose and operation of the Program.
(f)    (1)    The Secretary shall grant a waiver to a pharmacy that dispenses medications to an inpatient hospice from reporting to the Program prescription monitoring data for hospice inpatients if:
(i)    The pharmacy demonstrates how it will distinguish hospice inpatients from other consumers receiving medications from the pharmacy; and
(ii)    The pharmacy agrees that it will be subject to onsite, unannounced inspections by the Department to verify its reporting of the prescription data of consumers who are not hospice inpatients.
(2)    A waiver granted under this subsection may remain in effect for up to 2 years.
(3)    The Secretary may establish an application process for a pharmacy to apply for a waiver under this subsection.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2A - Prescription Drug Monitoring Program › Section 21-2A-04 - Regulations

(a)    The Secretary, in consultation with the Board, shall adopt regulations to carry out this subtitle.
(b)    The regulations adopted by the Secretary shall:
(1)    Specify the prescription monitoring data and naloxone medication data required to be submitted under § 21–2A–03 of this subtitle;
(2)    Specify the electronic or other means by which information is to be submitted:
(i)    Without unduly increasing the workload and expense on dispensers; and
(ii)    In a manner as compatible as possible with existing data submission practices of dispensers;
(3)    Specify that the information be submitted by dispensers once every 24 hours;
(4)    Specify that the Program:
(i)    Shall provide the information technology software to dispensers necessary to upload prescription drug monitoring data and naloxone medication data to the Program; and
(ii)    May not impose any fees or other assessments on prescribers or dispensers to support the operation of the Program;
(5)    Identify the mechanism by which:
(i)    Prescription monitoring data are disclosed to a person, in accordance with § 21–2A–06 of this subtitle; and
(ii)    Naloxone medication data are disclosed to a person, in accordance with § 21–2A–06.1 of this subtitle;
(6)    Identify the circumstances under which a person may disclose prescription monitoring data or naloxone medication data received under the Program;
(7)    Specify the process for the Program’s review of prescription monitoring data and naloxone medication data and reporting of:
(i)    Possible misuse or abuse of a monitored prescription drug under § 21–2A–06(c) of this subtitle; or
(ii)    A possible violation of law or possible breach of professional standards under § 21–2A–06(d) of this subtitle;
(8)    Establish requirements for Program retention of prescription monitoring data and naloxone medication data for 3 years; and
(9)    Require that:
(i)    Confidential or privileged patient information be kept confidential; and
(ii)    Records or information protected by a privilege between a health care provider and a patient, or otherwise required by law to be held confidential, be filed in a manner that, except as otherwise provided in §§ 21–2A–06 and 21–2A–06.1 of this subtitle, does not disclose the identity of the person protected.
2023 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.
2023 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.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2A - Prescription Drug Monitoring Program › Section 21-2A-06.1 - Naloxone Medication Data -- Confidential and Privileged -- Disclosure of Data Pursuant to Regulations

(a)    Naloxone medication data:
(1)    Are confidential and privileged, and not subject to discovery, subpoena, or other means of legal compulsion in civil litigation;
(2)    Are not public records; and
(3)    Except as provided in subsection (b) of this section or as otherwise by law, may not be disclosed to any person.
(b)    (1)    The Program shall disclose naloxone medication data, in accordance with regulations adopted by the Secretary, for public health surveillance, research, analysis, public reporting, and education after redaction of all information that could identify a patient, prescriber, dispenser, or any other individual.
(2)    The Secretary may require submission of an abstract explaining the scope and purpose of the research, analysis, public reporting, or education before disclosing naloxone medication data under paragraph (1) of this subsection.
2023 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.
2023 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 or naloxone medication data by a person to whom the Program was authorized to provide prescription monitoring data or naloxone medication 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.
2023 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 or naloxone medication 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 or naloxone medication 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 or naloxone medication 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.
2023 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.
2023 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.
2023 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.
2023 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.
2023 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.
2023 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.
2023 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.
2023 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.
2023 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.
2023 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.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2C - Prescription Drug Affordability Board › Section 21-2C-13 - Process for Setting 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.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2C - Prescription Drug Affordability Board › Section 21-2C-14 - Eligible Drug Products; Limit Amount; Drug Product Availability

(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.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2C - Prescription Drug Affordability Board › Section 21-2C-15 - Remedies

(a)    A person aggrieved by a decision of the Board may request an appeal of the decision within 30 days after the finding of the Board.
(b)    The Board shall hear the appeal and make a final decision within 60 days after the appeal is requested.
(c)    Any person aggrieved by a final decision of the Board may petition for judicial review as provided by the Administrative Procedure Act.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2C - Prescription Drug Affordability Board › Section 21-2C-16 - Report

On or before December 1, 2023, the Board, in consultation with the Stakeholder Council, shall report to the Senate Finance Committee and the House Health and Government Operations Committee, in accordance with § 2–1257 of the State Government Article, on:
(1)    The legality, obstacles, and benefits of setting upper payment limits on all purchases and payor reimbursements of prescription drug products in the State; and
(2)    Recommendations regarding whether the General Assembly should pass legislation to expand the authority of the Board to set upper payment limits to all purchases and payor reimbursements of prescription drug products in the State.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 3 - Food Establishments › Part I - Definitions; General Provisions › Section 21-302 - Scope of Subtitle

This subtitle does not apply to the manufacture of milk, milk products as defined in § 21–401 of this title, or frozen desserts as defined in § 21–801 of this title.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 3 - Food Establishments › Part I - Definitions; General Provisions › Section 21-303 - Purpose of Subtitle

The purpose of this subtitle is to provide that all food establishments in this State are constructed, operated, and maintained in a manner that assures that all food manufactured, processed, stored, or prepared for human consumption is done so under conditions necessary to protect the public health, safety, and welfare.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 3 - Food Establishments › Part I - Definitions; General Provisions › Section 21-304.1 - Written Notice of Intention to Serve Food to Public

(a)    A volunteer fire company that meets the requirements of an excluded organization under § 21-301(e) of this subtitle shall provide written notice to the Department that the volunteer fire company intends to serve food to the public for up to 30 consecutive days.
(b)    The written notice shall include the dates on which the food will be prepared, the methods of storing and serving the food, and the methods or procedures to be followed to ensure food safety and security.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 3 - Food Establishments › Part I - Definitions; General Provisions › Section 21-304.2 - Outdoor Dining -- Allowing Dogs With Patrons

(a)    A restaurant with an outdoor dining area may allow a patron’s dog to accompany the patron in the outdoor dining area during the hours designated by the owner of the restaurant.
(b)    The owner of a restaurant:
(1)    Shall provide written notice to the local health department that the owner intends to allow a patron’s dog to accompany the patron in the outdoor dining area of the restaurant not less than 30 days prior to the day on which dogs will be allowed in the outdoor dining area;
(2)    May determine the location and the amount of space in the outdoor dining area designated for a patron accompanied by a dog;
(3)    May establish limits on the size and type of dogs and any other limitations relating to dogs that may accompany a patron into the outdoor dining area of a restaurant;
(4)    May deny entry to the restaurant or eject from the restaurant any patron accompanied by a dog at the discretion of the owner; and
(5)    Shall place on permanent display a written notice that is in a typeface that is large enough to be easily legible to the average person from a distance of 8 feet and that is in a location that is plainly visible to the patrons of the restaurant notifying the patrons of the policy of the restaurant allowing dogs in the outdoor dining area.
(c)    A patron accompanied by a dog:
(1)    May not allow the dog to travel through an indoor space of a restaurant to enter or exit an outdoor dining area;
(2)    Shall keep the dog on a leash at all times with the patron at the table at which the patron is seated;
(3)    May not leave the dog unattended at any time in the restaurant;
(4)    Shall be an adult who is responsible for the behavior of the dog; and
(5)    Is liable for any damages caused by the dog to the restaurant or any other patron of the restaurant.
(d)    This section does not affect the right of an individual to use a service animal, as defined in § 7–701 of the Human Services Article.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 3 - Food Establishments › Part II - Licensing › Section 21-306 - Applications for License

(a)    To apply for a license, an applicant shall submit an application to the Department on the form that the Department requires.
(b)    The application form shall include:
(1)    The applicant’s name and address;
(2)    The location of the food establishment for which application is made;
(3)    The type of food establishment that the applicant proposes to operate; and
(4)    Any other information the Department requires.
2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 3 - Food Establishments › Part II - Licensing › Section 21-307 - Qualifications of Applicants; Inspections

(a)    To qualify for a license, an applicant shall:
(1)    Comply with the requirements of this subtitle and the rules and regulations adopted under this subtitle;
(2)    Agree to permit access to the food establishment for the purpose of any inspection permitted or required under this subtitle; and
(3)    Pay the license fee assessed under § 21-308 of this subtitle, unless exempted from the fee under this subtitle or any rule or regulation adopted under this subtitle.
(b)    Before issuing a license, the Department may inspect the food establishment identified in the application to determine if the food establishment meets the requirements for a license.