Section 21-238 – Authorization by Permit of Exceptions to Definitions and Standards
(a) If a temporary permit is issued under the federal act to authorize an interstate shipment that varies from the definitions and standards of identity set under the federal act, the permit is effective in this State under the conditions provided in the permit. (b) For experimental or other purposes, the Secretary may issue a permit that […]
Section 21-219 – Exemptions From Labeling and Packaging Requirements for Drugs and Devices Subject to Additional Processing, Labeling, or Packing
(a) A drug or device is not subject to the labeling or packaging requirements of this subtitle if a rule or regulation is adopted under the federal act or as provided under this section to exempt it. (b) The Secretary shall adopt rules and regulations to exempt from the labeling requirements of this subtitle any drug or […]
Section 21-220 – Prescription Requirements
(a) A drug that is intended for use by human beings and is in any of the following classifications may be dispensed by a pharmacist only on a written prescription, an electronic prescription, as defined in § 5–101 of the Criminal Law Article, or an oral prescription from a health practitioner authorized by law to prescribe […]
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, […]