Marvin Mandel, Governor                            861

of its toxicity or other potentiality for harmful effect, or the method
of its use, or the collateral measures necessary to its use, is not
safe for use except under the supervision of a practitioner licensed
by law to administer such drug; or (iii) is limited by an approved
application under Section 505 355 of the Federal Act or Section 189D
of this subheading to use under the professional supervision of a
practitioner licensed by law to administer such drug, shall be dis-
pensed only upon a written prescription of a practitioner licensed
by law to administer the drug, or upon an oral prescription of the
practitioner which is reduced promptly to writing and filed by the
pharmacist, or by refilling the written or oral prescription if the
refilling is authorized by the prescriber either in the original pre-
scription or by oral order which is reduced promptly to writing
and filed by the pharmacist. If any prescription for the drug does
not indicate the times it may be refilled, if any, the prescription
may not be refilled unless the pharmacist is subsequently authorized
to do so by the practitioner. The act of dispensing a drug contrary
to the provisions of this paragraph shall be an act which results
in a drug being misbranded while held for sale.

(b)    Any drug dispensed by filling or refilling a written or oral
prescription of a practitioner licensed by law to administer such
drug shall be exempt from the requirements of Section 189B, except
paragraphs (1), (10) (b), (10) (c), (12), and (13) thereof, and the
packaging requirements of subsections (8) and (9) thereof, if the
drug bears a label containing the name and address of the dispenser,
the serial number and date of the prescription or of its filling, the
name of the prescriber and, if stated in the prescription, the name
of the patient, and the directions for use and cautionary statements,
if any, contained in such prescription. This exemption shall not
apply to any drugs dispensed in the course of the conduct of a
business of dispensing drugs pursuant to diagnosis by mail, or to a
drug dispensed in violation of subsection (a) of this section.

(c)    The Secretary may, by regulation, remove drugs subject to
Section 189B (2) and Section 189D from the requirements of sub-
section (a) of this section when the requirements are not necessary
for the protection of the public health. Drugs removed from the
prescription requirements of the Federal Act by regulations issued
thereunder may also, by regulations issued by the Secretary, be
removed from the requirements of subsection (a).

(d)    A drug which is subject to subsection (a) of this section
shall be deemed to be misbranded if at any time prior to dispensing
its label fails to bear the statement "Caution: Federal Law Pro-
hibits Dispensing Without Prescription," or "Caution: State Law
Prohibits Dispensing Without Prescription." A drug to which sub-
section (a) of this section does not apply shall be deemed to be mis-
branded if at any time prior to dispensing its label bears the caution
statement quoted in the preceding sentence.

(e)    Nothing in this section shall be construed to relieve any per-
son from any requirement prescribed by or under authority of law
with respect to drugs now included or which may hereafter be
included within the classifications of narcotic drugs or marihuana
as defined in the applicable Federal and State laws relating to
narcotic drugs and marihuana.