§ 21-223. Approved applications required to sell, give away, or deliver new drugs
West's Annotated Code of MarylandHealth--General
MD Code, Health - General, § 21-223
§ 21-223. Approved applications required to sell, give away, or deliver new drugs
(a) This section does not apply to any drug that:
(b) A person may not sell, give away, or deliver any new drug:
(c) To have an application approved by the Secretary, an applicant shall file with the Secretary an application that sets forth:
(d) The Secretary may not approve an application filed under this section unless the drug has been tested and, under the conditions specified, recommended, or suggested in the proposed labeling of the drug, has been found to be safe for and effective in use.
(e) An application filed with the Secretary under this section shall be considered approved on the 180th day after it is filed, unless before that day and after giving the applicant notice and an opportunity for a hearing, the Secretary issues an order of disapproval under subsection (f) of this section on a finding that:
(f) If, before the date that the application otherwise would be considered approved the Secretary makes any of the findings that are enumerated in subsection (e) of this section concerning the drug, the Secretary shall issue an order that disapproves the application.
(g)(1) The Secretary may revoke an order that disapproved an application and the application then shall be considered approved.
(h) In accordance with any rule or regulation that is adopted or any order that is issued by the Secretary under this section, the person who holds an application for a drug that is approved under this section shall:
(i)(1) The Secretary may adopt rules and regulations that apply generally to persons whose applications for drugs have been approved or, as to a particular person whose application has been approved, issue an order that requires an applicant:
Credits
Added as Health-Environmental § 4-223 by Acts 1982, c. 240, § 2, eff. July 1, 1982. Transferred to Health-General § 21-223 by Acts 1987, c. 306, § 2, eff. July 1, 1987.
Formerly Art. 43, § 189B.
Footnotes
July 1, 1944, ch. 373, 58 Stat. 682, codified at 42 U.S.C.A. § 201 et seq.
Mar. 4, 1913, ch. 145, 37 Stat. 828, codified at 21 U.S.C.A. § 151 et seq.
MD Code, Health - General, § 21-223, MD HEALTH GEN § 21-223
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.
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