860                               Laws of Maryland                      [Ch. 422

(12)    If it is, or purports to be, or is represented as a drug com-
posed wholly or partly of insulin, unless (a) it is from a batch with
respect to which a certificate or release has been issued pursuant to
Section 506 356 of the Federal Act, and (b) such certificate or release
is in effect with respect to such drug.

(13)    If it is, or purports to be, or is represented as a drug com-
posed wholly or partly of any kind of penicillin, streptomycin,
chlortetracycline, chloramphenicol, bacitracin, or any other antibiotic
drug, or any derivative thereof, unless (a) it is from a batch with
respect to which a certificate or release has been issued pursuant to
Section 507 357 of the Federal Act, and (b) the certificate or release
is in effect with respect to the drug; provided, that this subsection
shall not apply to any drug or class of drugs exempted by regulations
promulgated under Section 507 357 (c) or (d) of the Federal Act. For
the purpose of this subsection the term "antibiotic drug" means
any drug intended for use by man containing any quantity of any
chemical substance which is produced by microorganisms and which
has the capacity to inhibit or destroy microorganisms in dilute solu-
tion (including, the chemically synthesized equivalent of the sub-
stance).

(14) If it is a color additive, the intended use of which in or on
drugs is for the purpose of coloring only, unless its packaging and
labeling are in conformity with such packaging and labeling re-
quirements applicable to such color additive, prescribed under the
provisions of Section 188F (b) of this subtitle or under the provi-
sions of the Federal Act.

(15)    In the case of any prescription drug distributed or offered
for sale in this State, unless the manufacturer, packer, or distributor
thereof includes in all advertisements and other descriptive printed
matter issued or caused to be issued by the manufacturer, packer
or distributor with respect to that drug a true statement of (a) the
established name, as defined in paragraph (6) of this section, printed
prominently and in type at least half as large as that used for any
trade or brand name thereof, (b) the formula showing quantitatively
each ingredient of the drug to the extent required for labels under
Section 502 352 (e) of the Federal Act, and (c) such other informa-
tion in brief summary relating to side effects, contraindications, and
effectiveness as shall be required in regulations issued under the
Federal Act.

(16)    If a trademark, trade name or other identifying mark, im-
print or device of another or any likeness of the foregoing has been
placed thereon or upon its container with intent to defraud.

(17)    Drugs and devices which are, in accordance with the prac-
tice of the trade, to be processed, labeled or repacked in substantial
quantities at establishments other than those where originally proc-
essed or packed shall be exempt from any labeling or packaging
requirements of this subheading; provided, that such drugs and
devices are being delivered, manufactured, processed, labeled, re-
packed or otherwise held in compliance with regulations issued by
the Secretary, or under the Federal Act.

189C.

(a) A drug intended for use by man which: (i) is a habit-
forming drug to which Section 189B (4) applies; or (ii) because