Md. Code Regs. 10.13.02.02

Current through Register Vol. 51, No. 25, December 13, 2024

Section 10.13.02.02 - Definitions

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

(1) "Adulterated" means a drug or device where:

(a) Any part of the drug or device is filthy, putrid, or a decomposed substance; or

(b) The drug or device was produced, prepared, packed, or held under unsanitary conditions that reasonably would be expected to have:

(i) Contaminated the drug or device with filth; or

(ii) Caused the drug or device to be injurious to health.

(2) "Board" means the State Board of Pharmacy.

(3) "Department" means the Department of Health and Mental Hygiene.

(4) "Misbranded" means a drug or device where:

(a) The drug's or device's:

(i) Labeling is false or misleading in any way; or

(ii) Labeling or packaging does not conform with Health-General Article, §21-248, Annotated Code of Maryland;

(b) The drug or device is in package form and does not bear a label that contains the name and place of business of the manufacturer, packer, or distributor;

(c) Any word, statement, or other information required under Health-General Article, Title 21, Subtitle 2, Annotated Code of Maryland, to appear on the drug's or device's labeling is not placed prominently on the labeling in a manner that is:

(i) Conspicuous as compared with other words, statements, designs, or symbols on the labeling; and

(ii) In terms likely to be read and understood by the ordinary individual under customary conditions of purchase and use;

(d) The drug's or device's labeling does not include, in whatever manner and form that may be necessary to protect the user of the drug or device, adequate directions for the use of the drug or device;

(e) The drug's or device's labeling does not include, in whatever manner and form that may be necessary to protect the user of the drug or device, adequate warnings against:

(i) The use of the drug or device by anyone suffering from a pathological condition that may cause the drug's or device's use to be dangerous to health;

(ii) The use of the drug or device by a child if the use by a child may be dangerous; and

(iii) Unsafe dosages, methods of administration, or duration of administration of the drug or device;

(f) The drug or device is dangerous to health when used in the dosage, with the frequency, or for the duration specified, recommended, or suggested in the labeling of the drug or device; or

(g) The trademark, trade name, imprint, symbol, or other identifying mark of another drug or any likeness of any of these markings of another drug or device is placed on the drug or device or its container with the intent to defraud.

(5) "Pedigree" means a record of the tracking of a drug or device through the supply chain, with each trading partner authenticating the drug or device upon receipt and transfer.

(6) "Prescription device" means a device required by federal law or regulation to be dispensed only by a prescription.

(7) Prescription Drug.

(a) "Prescription drug" means a drug required by federal law or regulation to be dispensed only by a prescription.

(b) "Prescription drug" includes:

(i) A biological product; and

(ii) Finished dosage forms and bulk drug substances subject to § 503(b) of the Federal Food, Drug, and Cosmetic Act.

(c) "Prescription drug" does not include:

(i) Blood and blood components intended for transfusion; or

(ii) Biological products that are also medical devices.

(8) "Public health purposes" includes the purpose of controlling communicable diseases or environmental health hazards.

(9) "Secretary" means the Secretary of Health and Mental Hygiene.

Md. Code Regs. 10.13.02.02