Illinois General Assembly - Illinois Compiled Statutes

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410 ILCS 620/16

(410 ILCS 620/16) (from Ch. 56 1/2, par. 516)

Sec. 16.

(a) The Director is hereby authorized to promulgate
regulations exempting from any labeling or packaging requirement of this
Act drugs and devices which are (i) in accordance with the practice of the
trade, to be processed, labeled or repacked in substantial quantities at
establishments other than those where originally processed or packaged on
condition that such drugs and devices are not adulterated or misbranded
under the provisions of this Act upon removal from such processing,
labeling or repacking establishment or (ii) packaged, repackaged, or labeled to the
extent permitted under the Illinois Drug Reuse Opportunity Program Act.

(b) Drugs and device labeling or packaging exemptions adopted under the
Federal Act and supplements thereto or revisions thereof shall apply to
drugs and devices in Illinois except insofar as modified or rejected by
regulations promulgated by the Director.

(c) A drug intended for use by man which (A) is a habit-forming drug to
which Section 15 (d) applies; or (B) because 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
(C) is limited by an approved application under Section 505 of the Federal
Act or Section 17 of this Act to use under the professional supervision of
a practitioner licensed by law to administer such drug, shall be dispensed
only in accordance with the provisions of the "Illinois Controlled
Substances Act". The act of dispensing a drug contrary to the provisions of
this paragraph shall be deemed to be an act which results in a drug being
misbranded while held for sale.

(d) 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 15, except
subsections (a), (k) and (l) and clauses (2) and (3) of subsection (i), and
the packaging requirements of
subsections (g), (h) and (q), if the drug bears a label containing the
proprietary name or names, or if there is none, the established name or
names of the drugs, the dosage and quantity, unless the prescribing
practitioner, in the interest of the health of the patient, directs
otherwise in writing, 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 the cautionary statements, if any, contained in
such prescription. This exemption shall not apply to any drug dispensed in
the course of the conduct of business of dispensing drugs pursuant to
diagnosis by mail, or to a drug dispensed in violation of subsection (a) of
this Section.

(e) The Director may by regulation remove drugs subject to
Section 15 (d) and Section 17 from the requirements of subsection (c) of
this Section when such requirements are not necessary for the protection of
the public health.

(f) A drug which is subject to subsection (c) of this Section
shall be deemed to be misbranded if at any time before dispensing its label
fails to bear the statement "Caution: Federal Law Prohibits Dispensing Without
Prescription" or "Caution: State Law Prohibits Dispensing Without
Prescription". A drug to which subsection (c) of this Section does not apply
shall be deemed to be misbranded if at any time prior to dispensing its
label bears the caution statement quoted in the preceding sentence.

(g) Nothing in this Section shall be construed to relieve
any person from any requirement prescribed by or under authority of law
with respect to controlled substances now included or which may hereafter
be included within the classifications of controlled substances cannabis as
defined in applicable Federal laws relating to controlled substances or
cannabis or the Cannabis Control Act.

(Source: P.A. 102-389, eff. 1-1-22.)