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 21-211 – Control of Food Subject to Contamination With Microorganisms
(a) By the issuance, denial, or suspension of permits as provided in this section, the Secretary may regulate the distribution in this State of any class of food that may be contaminated with microorganisms. (b) (1) The Secretary shall adopt rules and regulations that provide for the issuance of permits to food manufacturers, processors, or packers in any […]
Section 21-212 – Exemptions From Labeling Requirements for Foods Subject to Additional Processing, Labeling, or Packing
(a) A food is not subject to the labeling requirements of this subtitle if a rule or regulation is adopted as provided under this section to exempt it. (b) Subject to the provisions of § 21-241 of this subtitle, any rule or regulation adopted under the federal act to exempt a food from labeling requirements is effective […]
Section 21-213 – Special Dietary Use Rules and Regulations
(a) Subject to the provisions of § 21-241 of this subtitle, any special dietary use rule or regulation that is adopted by the federal government under the federal act automatically is adopted as a rule or regulation of this State. (b) Whether or not in accordance with any rule or regulation adopted under the federal act, the […]
Section 21-101 – Definitions
(a) In this title the following words have the meanings indicated. (b) “Advertisement” means any representation that: (1) Is intended or is likely to induce, directly or indirectly, any person to purchase any food, drug, device, or cosmetic; and (2) Is published by any means other than labeling. (c) (1) “Color additive” means any material that: (i) Is a dye, pigment, or […]
Section 21-102 – Scope of Title
(a) The provisions of this title that relate to the sale of a consumer commodity also apply to: (1) Manufacturing, producing, processing, packing, exposing, offering, possessing, or holding the consumer commodity for sale; (2) Dispensing or giving the consumer commodity; and (3) Supplying or applying the consumer commodity in the operation of any food, drug, or cosmetic establishment. (b) If […]
Section 21-201 – Definitions
(a) In this subtitle the following words have the meanings indicated. (b) “Counterfeit drug” means a drug that: (1) Bears, or the container or labeling of which bears, without authorization, the trademark, trade name, imprint, symbol, or any other identifying mark, or any likeness of any of these markings, of a manufacturer, processor, packer, or distributor other than […]
Section 21-202 – Scope of Subtitle
(a) Any drug that is designated as a “controlled dangerous substance” under Title 5 of the Criminal Law Article is governed by that title as well as by this subtitle. (b) If, as to any drug that is a “controlled dangerous substance”, there is any conflict between the provisions of this subtitle and those of Title 5 […]
Section 21-203 – Application of Label Requirements to Outside Container or Wrapper
If there is an outside container or wrapper for a food, drug, device, or cosmetic, then, to comply with any requirement that is imposed under this subtitle that a word, statement, or any other information appear on the label or the article, the word, statement, or other information also shall: (1) Be placed on the outside […]