1876

LAWS OF MARYLAND

Ch. 240

In subsection (c)(2) of this section, the
reference to a finding under § 4-239 of this
subtitle is substituted for the reference to the
Federal Act. While, ultimately, the
determination of whether a color additive is to
be considered safe in this State is most apt to
be made under the Federal Act, that determination
can be made by the Secretary under this subtitle.
Section 4-239 of this subtitle sets forth the
process by which a determination is made under
either the Federal Act or this subtitle.

In subsection (d)(2) of this section, reference
to the "United States Pharmacopeia and National
Formulary" is substituted for the language that
refers only to the "United States Pharmacopeia".
These publications have merged since former
Article 43, § 189A was enacted.

4-217. MISBRANDED DRUGS AND DEVICES.

(A)  APPLICATION OF SECTIONS.

FOR PURPOSES OF THIS SUBTITLE, A DRUG OR DEVICE IS
MISBRANDED IF THE STANDARDS IN THIS SECTION OR IN § 4-218 OR
§ 4-220(D) OR (E) OF THIS SUBTITLE APPLY.

(B)  IN GENERAL.

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 PROVISION OF § 4-248 OF THIS SUBTITLE;

(3)  IT IS IN PACKAGE FORM AND IT DOES NOT BEAR A
LABEL THAT CONTAINS THE NAME AND PLACE OF BUSINESS OF THE
MANUFACTURER, PACKER, OR DISTRIBUTOR;

(4)  ANY WORD, STATEMENT, OR OTHER INFORMATION
REQUIRED UNDER THIS SUBTITLE TO APPEAR ON ITS 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;

(5)  ITS LABELING DOES NOT INCLUDE, IN WHATEVER
MANNER AND FORM THAT MAY BE NECESSARY TO PROTECT THE USER OF
THE DRUG OR DEVICE: