Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 3
Subtitle 13 - DRUGS
Chapter 10.13.02 - Purchase and Distribution of Prescription Drugs and Devices
Section 10.13.02.02 - Definitions
Universal Citation: MD Code Reg 10.13.02.02
Current through Register Vol. 51, No. 19, September 20, 2024
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.
Disclaimer: These regulations may not be the most recent version. Maryland may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
