§ 21-224. Exemption of new drugs from application requirements
West's Annotated Code of MarylandHealth--General
MD Code, Health - General, § 21-224
§ 21-224. Exemption of new drugs from application requirements
(a)(1) A new drug is not subject to the requirements of § 21-223 of this subtitle if it is exempted by a rule or regulation adopted under this section.
(b) The Secretary shall adopt rules and regulations to exempt from the requirements of § 21-223 of this subtitle any drug that is intended only for investigational use by experts who are qualified by scientific training and experience to investigate the safety and effectiveness of the drug. In addition to any other conditions that may be imposed for the protection of the public health, the rules and regulations may require as a condition for the exemption of a drug that:
(3) The manufacturer of a new drug or the sponsor of the investigation of the drug keep records of, and make reports to the Secretary of, the information obtained from the investigational use of the drug, including analytical reports by investigators, as the Secretary finds will assist in the evaluation of the safety and effectiveness of the drug if an application for the drug is filed under § 21-223 of this subtitle.
(c)(1) When adopting a rule or regulation that requires the submission of information under this subsection, the Secretary shall consider the professional ethics of the medical profession and the interests of patients.
(2) Any rule, regulation, or order under this section shall provide that if any person to whom the rule, regulation, or order applies requests it, and if the Secretary considers it to be appropriate, the person may examine any similar information that is obtained by the Secretary concerning the drug.
(d)(1) Any rule or regulation adopted under § 355(i) of the federal act automatically shall be a rule or regulation of this State, as provided in § 21-241 of this subtitle.
Credits
Added as Health-Environmental § 4-224 by Acts 1982, c. 240, § 2, eff. July 1, 1982. Transferred to Health-General § 21-224 by Acts 1987, c. 306, § 2, eff. July 1, 1987. Amended by Acts 1987, c. 306, § 15, eff. July 1, 1987; Acts 1988, c. 6, § 11, eff. July 1, 1988.
Formerly Art. 43, § 189D.
MD Code, Health - General, § 21-224, MD HEALTH GEN § 21-224
Current through legislation effective through May 9, 2024, from the 2024 Regular Session of the General Assembly. Some statute sections may be more current, see credits for details.
End of Document |