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 […]
Section 21-2C-08 – Collection, Review, and Use of Transparency Data for Prescription Drug Products
(a) On or before December 31, 2021, the Board shall: (1) Collect and review publicly available information regarding prescription drug product manufacturers, health insurance carriers, health maintenance organizations, managed care organizations, wholesale distributors, and pharmacy benefits managers; and (2) (i) Identify states that require reporting on the cost of prescription drug products; and (ii) Initiate a process of entering into […]
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 […]
Section 21-259.2 – Prohibition on Certain Ingredients Knowingly Included in Cosmetic Products
** 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) […]
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 […]
Section 21-259.3 – Animal Testing Prohibited in Development of Cosmetic — Inapplicable to Certain Animal Testing — Local Law on Animal Testingprohibited — Civil Penalties — Enforcement
(a) (1) In this section the following words have the meanings indicated. (2) “Animal testing” means the internal or external application or exposure of a cosmetic or any component of a cosmetic to the skin, eye, or any other body part of a live nonhuman vertebrate. (3) “Ingredient” has the meaning stated in 21 C.F.R. § 700.3(e). (4) “Manufacturer” means […]
Section 21-2B-01 – Definitions
(a) In this subtitle the following words have the meanings indicated. (b) “Carrier” has the meaning stated in § 15–10A–01(c) of the Insurance Article. (c) “Eligible patient” means an individual who: (1) Has a terminal illness, attested to by the individual’s treating physician; (2) Has considered all other treatment options currently approved by the United States Food and Drug Administration; […]
Section 21-260 – Defenses to Alleged Violations; Burden of Proof
(a) Except as to an alleged violation that is enumerated under subsection (b)(2) of this section, a person may not be convicted of any violation of this part, if, with respect to the alleged violation, the person establishes by a preponderance of evidence that the person did not commit the alleged violation purposely, knowingly, recklessly, or […]
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 […]
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 […]