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 […]
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 […]
Section 21-263 – Short Title
This subtitle may be cited as the “Maryland Food, Drug, and Cosmetic Act”.
Section 21-2A-01 – Definitions
(a) In this subtitle the following words have the meanings indicated. (b) “Board” means the Advisory Board on Prescription Drug Monitoring. (c) (1) “Dispense” has the meaning stated in § 12–101 of the Health Occupations Article. (2) “Dispense” does not include: (i) Directly administering a monitored prescription drug to a patient; or (ii) Giving out prescription drug samples. (d) (1) “Dispenser” means a person […]
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 […]