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1878
LAWS OF MARYLAND
Ch. 240
As to subsection (c)(2) of this section, the
exemption under former Article 43, § 189B(7)
referred to "any requirement of clause 1 of this
subsection". However, there was no "clause 1" in
former § 189B(7). The appropriate scope of the
exemption was determined by checking the
provision of the Federal Act from which former
Article 43, § 189B was derived. See 21 U.S.C. §
352(f). That provision uses a "(1)" where former
Article 43, § 189B(7) used an "(a)", and, for
consistency, the later reference in former
Article 43, § 189B(7) to "clause (1)" should have
been to "clause (a)". The apparent intent, in
any event, was to make the reference to
exemptions apply only to the requirement for
directions in labeling and not the requirement
for warnings. Subsection (c)(2) of this section
is revised accordingly.
4-218. MISBRANDED DRUGS.
(A) "ANTIBIOTIC DRUG" DEFINED.
IN THIS SECTION "ANTIBIOTIC DRUG" MEANS ANY DRUG THAT:
(1) IS INTENDED FOR USE BY A HUMAN BEING;
(2) CONTAINS ANY QUANTITY OF A CHEMICAL
SUBSTANCE OR THE CHEMICALLY SYNTHESIZED EQUIVALENT OF A
CHEMICAL SUBSTANCE THAT IS PRODUCED BY MICROORGANISMS; AND
(3) CAN INHIBIT OR DESTROY MICROORGANISMS IN
DILUTE SOLUTION.
(B) IN GENERAL.
IN ADDITION TO ANY OTHER GROUND THAT MAY APPLY UNDER §
4-217 OR § 4-220 OF THIS SUBTITLE, A DRUG IS MISBRANDED IF:
(1) IT IS FOR USE BY A HUMAN BEING AND CONTAINS
ANY QUANTITY OF THE NARCOTIC OR HYPNOTIC SUBSTANCE
ALPHA-EUCAINE, BARBITURIC ACID, BETA-EUCAINE, BROMAL,
CANNABIS, CARBROMAL, CHLORAL, COCA LEAVES, COCAINE, CODEINE,
HEROIN, MARIJUANA, MORPHINE, OPIUM, PARALDEHYDE, PEYOTE,
SULPHONMETHANE, OR ANY CHEMICAL DERIVATIVE OF ANY OF THESE
SUBSTANCES, WHICH DERIVATIVE, AFTER INVESTIGATION, HAS BEEN
DESIGNATED AS HABIT FORMING UNDER A RULE OR REGULATION
ADOPTED UNDER THE FEDERAL ACT OR BY THE SECRETARY UNDER THIS
SUBTITLE, UNLESS ITS LABEL STATES THE NAME AND QUANTITY OR
PROPORTION OF THE SUBSTANCE OR DERIVATIVE AND, IMMEDIATELY
BESIDE THAT INFORMATION, A WARNING THAT STATES: "WARNING --
MAY BE HABIT FORMING.";
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