Section 21-221 – Label Requirements for Prescription Drugs; Exemption From Provisions on Misbranded Drugs
(a) A drug that is dispensed under a prescription shall bear a label that states: (1) The name and address of the dispenser; (2) The serial number of the prescription; (3) The date of the prescription or the date that the prescription was filled; (4) The name of the prescriber; and (5) If stated in the prescription: (i) The name of the […]
Section 21-222 – Construction of 21-220 and 21-221
Nothing in § 21-220 or § 21-221 of this subtitle relieves any person from any requirement imposed by law with respect to any drug that is classified as a controlled dangerous substance within the meaning of Title 5 of the Criminal Law Article or the applicable federal law.
Section 21-223 – New Drugs — in General
(a) This section does not apply to any drug that: (1) Was sold in this State or introduced into interstate commerce at any time before the enactment of the federal act, if its labeling contained the same representations concerning the conditions of its use; or (2) Is licensed under the Public Health Service Act of July 1, 1944 […]
Section 21-224 – New Drugs — Exemption When Intended for Investigational Use Only
(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. (2) This section does not require any clinical investigator to submit directly to the Secretary any report on the investigational use of a drug. (b) The Secretary shall adopt […]
Section 21-225 – New Drugs — Inspection of Records
Any person who is required under § 21-223 or § 21-224 of this subtitle to keep records and any person who is in charge or custody of any of these records, on the request of the Secretary, shall permit the Secretary to have access to, copy, and verify the records at any reasonable time.
Section 21-226 – Printed Information for Use of Practitioners
(a) The manufacturer, packer, or distributor of any prescription drug that is sold or distributed in this State shall: (1) Keep correct copies of any printed matter that is: (i) Required to be included in any package in which the drug is sold or distributed; or (ii) Approved under the federal act; and (2) Send copies of the printed matter […]
Section 21-227 – Provision of Information on Request of Secretary
On a specific written request by the Secretary, the manufacturer, packer, or distributor of any prescription drug that is sold or distributed in this State shall give the Secretary: (1) Any information that the manufacturer, packer, or distributor has about the biological availability and clinical performance of the drug; and (2) Any comparative information that the manufacturer, […]
Section 21-216 – Adulterated Drugs and Devices
(a) For purposes of this subtitle, a drug or device is adulterated if the standards in this section apply. (b) A drug or device is adulterated if: (1) Any part of it is a filthy, putrid, or decomposed substance; or (2) It was produced, prepared, packed, or held under unsanitary conditions that reasonably would be expected to have: (i) Contaminated […]
Section 21-217 – Misbranded Drugs and Devices — in General
(a) For purposes of this subtitle, a drug or device is misbranded if the standards in this section or in § 21-218 or § 21-220(d) or (e) of this subtitle apply. (b) A drug or device is misbranded if: (1) Its labeling is false or misleading in any way; (2) Its labeling or packaging does not conform with any […]
Section 21-218 – Additional Grounds of Drug Misbranding
(a) In this section, “antibiotic drug” means any drug that: (1) Is intended for use by a human being; (2) Contains any quantity of a chemical substance or the chemically synthesized equivalent of a chemical substance that is produced by microorganisms; and (3) Can inhibit or destroy microorganisms in dilute solution. (b) In addition to any other ground that may […]