HARRY HUGHES, Governor

1877

(I)  ADEQUATE DIRECTIONS FOR THE USE OF THE
DRUG OR DEVICE; AND

(II)  ADEQUATE WARNINGS AGAINST:

1.  THE USE OF THE DRUG OR DEVICE BY
ANYONE SUFFERING FROM A PATHOLOGICAL CONDITION THAT MAY
CAUSE ITS USE TO BE DANGEROUS TO HEALTH;

2.  THE USE OF THE DRUG OR DEVICE BY
A CHILD IF ITS USE BY A CHILD MAY BE DANGEROUS; AND

3.  UNSAFE DOSAGES, METHODS OF
ADMINISTRATION, OR DURATION OF ADMINISTRATION OF THE DRUG OR
DEVICE;

(6)  IT 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

(7)  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.

(C) EXEMPTIONS FROM LABELING REQUIREMENTS.

(1)  SUBSECTION (B)(5)(I) OF THIS SECTION, WHICH
CONCERNS THE PROVISION OF DIRECTIONS FOR THE USE OF A DRUG
OR DEVICE, DOES NOT APPLY TO A DRUG OR DEVICE THAT IS
EXEMPTED BY:

(I)  A RULE OR REGULATION ADOPTED UNDER THE
FEDERAL ACT; OR

(II)  A RULE OR REGULATION ADOPTED BY THE
SECRETARY UNDER THIS SUBSECTION.

(2)  IF THE SECRETARY FINDS THAT, AS APPLIED TO A
PARTICULAR DRUG OR DEVICE, ANY REQUIREMENT OF SUBSECTION
(B)(5)(I) OF THIS SECTION IS NOT NECESSARY FOR THE
PROTECTION OF THE PUBLIC HEALTH, THE SECRETARY SHALL ADOPT A
RULE- OR REGULATION TO EXEMPT THE DRUG OR DEVICE FROM THAT
REQUIREMENT.

REVISOR'S NOTE: This section is new language derived
without substantive change from former Article
43, § 189B(1), (2), (3), (7), (11), and (16).

As to the reference to the Federal Act in
subsection (c)(1) of this section, see 21 U.S.C.
352(f).