Ill. Admin. Code tit. 77, § 720.50 - Drugs and Devices
a)
Drugs: Name.
The name by which a drug is designated shall be clearly distinguishing and differentiating from any name recognized in an official compendium unless such drug complies in identity with the identity prescribed in an official compendium under such recognized name.
b) The term "drug defined in an official
compendium" means a drug having the identity prescribed for a drug in an
official compendium.
c) A statement
that a drug defined in an official compendium differs in strength, quality or
purity from the standard of strength, quality or purity set forth for such drug
in an official compendium shall show all the respects in which such drug so
differs, and the extent of each such difference.
d) Drugs and Devices: Labeling , Misbranding.
Among representations in the
e) The labeling of a drug which contains two
or more ingredients may be misleading by reason (among other reasons) of the
designation of such drug in such labeling by a name which includes or suggests
the name of one or more but not all such ingredients, even though the names of
all such ingredients are stated elsewhere in the labeling .
f) Drugs and Devices: Place of Business.
If a drug or device is not manufactured by the
g) The statement of the place of business
shall include the street address, if any, of such place, unless such street
address is shown in a current city directory or telephone directory.
h) Where a person manufactures, packs or
distributes a drug or device at a place other than his principal place of
business, the label may state the principal place of business in lieu of the
actual place where each package of such drug or device was manufactured or
packed or is to be distributed, if such statement is not misleading in any
particular.
i) The requirement that
the label shall contain the name and place of business of the manufacturer,
packer or distributor shall not be considered to relieve any drug or device
from the requirement that its label shall not be misleading in any
particular.
j)
1) The statement of the quantity of the
contents of a package of a drug shall reveal the quantity of such drug in the
package, exclusive of wrappers and other material packed with such
drug.
2) The statement shall be
expressed in the terms of weight, measure, numerical count, or a combination of
numerical count and weight or measure, which are generally used by consumers
and users of such drug to express quantity thereof and which give accurate
information as to such quantity. But if no general usage in expressing accurate
information as to the quantity of such drug exists among consumers and users
thereof, the statement of the quantity of a drug which is not in tablet,
capsule, ampule or other unit form shall be in terms of weight if the drug is
solid, semisolid or viscous, or in terms which if in such unit form shall be in
terms of the numerical count of such units, supplemented, when necessary to
give accurate information as to the quantity of such drug in the package, by
such statement (in such terms, manner and form as are not misleading) of the
weight or measure of such units, or of the quantity of each active ingredient
in each such unit as will give such information.
k) The statement of the quantity of a device
shall be expressed in terms of numerical count.
l) A statement of weight shall be in terms of
the avoirdupois pound, ounce and grain, or of the kilogram, gram and milligram.
A statement of liquid measure shall be in terms of the United States gallon of
231 cubic inches and quart, pint, fluid ounce and fluid dram subdivisions
thereof, or of the liter, milliliter or cubic centimeter, and shall express the
volume at 68° Fahrenheit (20° Centigrade).
m) Statements of the quantity of a drug shall
contain only such fractions as are generally used in expressing the quantity of
such drug. A common fraction shall be reduced to its lowest terms; a decimal
fraction shall not be carried out to more than three places, except in the case
of a statement of the quantity of an active ingredient in a unit of a
drug.
n)
1) Unless made in accordance with the
provisions of subsection (n)(2) of this Section, a statement of the quantity of
a drug, in the terms of weight or measure applicable to such drug under the
provisions of subsection (j)(2) of this Section, shall express the number of
the largest unit specified in subsection (l) of this Section which is contained
in the package (for example, the statement on the label of a package which
contains one pint of a drug shall be "1 pint" and not "16 fluid ounces"). Where
such number is a whole number and a fraction, there may be substituted for the
fraction its equivalent in smaller units, if any smaller is specified in
subsection (l) of this Section (for example, 11/4 pounds may be expressed as "1
pound 4 ounces"). The stated number of any unit which is smaller than the
largest unit (specified in subsection (l) of this Section) contained in the
package shall not equal or exceed the number of such smaller units in the next
larger unit so specified (for example, instead of "1 quart 16 fluid ounces" the
statement shall be "11/2 quarts" or "1 quart 1 pint").
2) In the case of a drug with respect to
which there exists an established custom of stating the quantity of the
contents as a fraction of a unit, which unit is larger than the quantity
contained in the package, or as units smaller than the largest unit contained
therein, the statement may be made in accordance with such custom if it is
informative to consumers.
o) The statement of the quantity of a drug or
device shall express the minimum quantity, or the average quantity, of the
contents of the packages. If the statement is not so qualified as to show
definitely that the quantity expressed is the minimum quantity, the statement,
except in the case of ampules, shall be considered to express the average
quantity. The statement of the quantity of a drug in ampules shall be
considered to express the minimum quantity.
p) Where the statement expresses the minimum
quantity, no variation below the stated minimum shall be permitted except
variations below the stated weight or measure of a drug caused by ordinary and
customary exposure, after such drug is introduced into commerce, to conditions
which normally occur in good distribution practice and which unavoidably result
in decreased weight or measure. Variations above the stated minimum shall not
be unreasonably large. In the case of a liquid drug in ampules the variation
above the stated measure shall comply with the excess volume prescribed by the
National Formulary for filling of ampules.
q) Where the statement does not express the
minimum quantity:
1) Variations from the
stated weight or measure of a drug shall be permitted when caused by ordinary
and customary exposure after such drug is introduced into commerce, to
conditions which normally occur in good distribution practice and which
unavoidably result in change of weight or measure;
2) Variations from the stated weight, measure
or numerical count of a drug or device shall be permitted when caused by
unavoidable deviations in weighing, measuring or counting the contents of
individual packages which occur in good packing practice. But, under this
paragraph, variations shall not be permitted to such extent that the average of
the quantities in the packages comprising a shipment or other delivery of the
drug or device is below the quantity stated and no unreasonable shortage in any
package shall be permitted, even though coverages in other packages in the same
shipment or delivery compensate for such shortage.
r) The extent of variations from the stated
quantity of the contents permissible under subsections (p) and (q) of this
Section in the case of each shipment or other delivery shall be determined by
the facts in such case.
s) A drug
or device shall be exempt from compliance with the requirements of Section
15(b)(2) of the Act if:
1) The statement of
the quantity of the contents, as expressed in terms applicable to such drug or
device under the provisions of subsection (j)(2) of this Section, together with
all other words, statements and information required by or under authority of
the Act to appear on the label of such drug or device, cannot, because of
insufficient label space, be so placed on the label as to comply with
requirements of Section 15(c) of the Act and regulations promulgated
thereunder, or
2) The quantity of
the contents of the package, as expressed in terms of numerical count in
compliance with subsections (l)(2) or (m) of this Section is less than six
units, and such units can be easily counted without opening the package,
or
3) It is an ointment, is labeled
"Sample" or "Physician 's Sample," or with a substantially similar statement,
and the contents of the package do not weigh more than 8 grams.
t) Drugs and Devices: Forms of
Making Required Statements.
A word, statement or other information required by or under
authority of the
1) The failure of such
word, statement or information to appear on the part or panel of the label
which is presented or displayed under customary conditions of the
purchase;
2) The failure of such
word, statement or information to appear on two or more parts or panels of the
label, each of which has sufficient space therefor, and each of which is so
designed as to render it likely to be, under customary conditions of purchase,
the part or panel displayed;
3) The
failure of the label to extend over the area of the container or package
available for such extension, so as to provide sufficient label space for the
prominent placing of such word, statement or information;
4) Insufficiency of label space (for the
prominent placing of such word, statement or information) resulting from the
use of label space for any word, statement, design or device which is not
required by or under authority of the Act to appear on the label;
5) Insufficiency of label space (for the
prominent placing of such word, statement or information) resulting from the
use of label space to give materially greater conspicuousness to any other
word, statement or information, or to any design or device; or
6) Smallness or style of type in which such
word, statement or information appears, insufficient background contrast,
obscuring designs or vignettes, or crowding with other written, printed or
graphic matter.
u) No
exemption depending on insufficiency of label space, as prescribed in
regulations promulgated under Section 15(b) or (e) of the Act , shall apply if
such insufficiency is caused by:
1) The use of
label space for any word, statement, design or device which is not required by
or under authority of the Act to appear on the label;
2) The use of label space to give greater
conspicuousness to any word, statement or other information than is required by
Section 15(c) of the Act ; or
3) The
use of label space for any representation in a foreign language.
v)
1) All words, statements and other
information required by or under authority of the Act to appear on the label or
labeling shall appear thereon in the English language;
2) If the label contains any representation
in a foreign language, all words, statement and other information required by
or under authority of the Act to appear on the label shall appear thereon in
the foreign language;
3) If the
labeling contains any representation in a foreign language, all words,
statements and other information required by or under authority of the Act to
appear on the label or labeling shall appear on the labeling in the foreign
language.
w) Drugs:
Statement of Ingredients.
The ingredient information required by Section 15(e) of the
x) The term "ingredient" applies to any
substance in the drug, whether added to the formulation as a single substance
or in admixture with other substances.
y) The labeling of a drug may be misleading
by reason (among other reasons) of:
1) The
order in which the names of the ingredients present in the drug appear in the
labeling , or the relative prominence otherwise given such names;
2) Failure to reveal the proportion of, or
other fact with respect to, an ingredient present in such drug, when such
proportion or other fact is material in the light of the representation that
such ingredient is present in such drug;
3) The employment of a fanciful proprietary
name for a drug or ingredient in such a manner as to imply that the drug or
ingredient has some unique effectiveness or composition when, in fact, the drug
or ingredient is a common substance, the limitations of which are readily
recognized when the drug or ingredient is listed by its established
name;
4) The featuring in the
labeling of inert or inactive ingredients in a manner that creates an
impression of value greater than their true functional role in the
formulation;
5) Designation of a
drug or ingredient by a proprietary name that, because of similarity in
spelling or pronunciation, may be confused with the proprietary name or the
established name of a different drug or ingredient.
z)
1) If
the drug is in tablet or capsule form or other unit dosage form, any statement
of the quantity of an ingredient contained therein shall express the quantity
of such ingredient in each such unit. If the drug is not in unit dosage form,
any statement of the quantity of an ingredient contained therein shall express
the amount of such ingredient in a specified unit of weight or measure of the
drug, or the percentage of such ingredient in such drug. Such statements shall
be in terms that are informative to licensed practitioners, in the case of a
prescription drug, and to the layman, in the case of a nonprescription
drug.
2) A statement of the
percentage of an ingredient in a drug shall, if the term "percent" is used
without qualification, mean percent weight-in-weight, if the ingredient and the
drug are both solids, or if the ingredient is a liquid and the drug is a solid;
percent weight-in-volume at 68° F. (20° C.), if the ingredient is a solid and
the drug is a liquid; and percent volume-in-volume at 68° F. (20° C.), if both
the ingredient and the drug are liquids, except that alcohol shall be stated in
terms of percent volume of absolute alcohol at 60° F. (15.56 ° C.).
aa) A derivative or preparation of
a substance named in Section 15(c) of the Act is an article derived or prepared
from such substance by any method, including actual or theoretical chemical
action.
bb) If an ingredient is a
derivative or preparation of a substance specifically named in Section 15(e) of
the Act and the established name of such ingredient does not indicate that it
is a derivative or preparation of the parent substance named in Section 15(e)
of the Act , the labeling shall, in conjunction with the listing of the
established name of such ingredient, declare that such article is a derivative
or preparation of such parent substance.
cc)
1) If
the label or labeling of a prescription drug bears a proprietary name or
designation for the drug or any ingredient thereof, the established name, if
such there be, corresponding to such proprietary name or designation, shall
accompany each appearance of such proprietary name or designation. The
established name shall be placed in direct conjunction with the proprietary
name or designation, and the relationship between the proprietary name or
designation and the established name shall be made clear by use of a phrase
such as "brand of," preceding the established name, or by brackets surrounding
the established name.
2) The
established name shall be printed in letters that are at least half as large as
the letters comprising the proprietary name or designation with which it is
jointed, and the established name shall have a prominence commensurate with the
prominence with which such proprietary name or designation appears, taking into
account all pertinent factors, including typography, layout, contrast and other
printing features.
dd)
1) In the case of a prescription drug
containing two or more active ingredients, if the label bears a proprietary
name or designation for such mixture and there is no established name
corresponding to such proprietary name or designation, the quantitative
ingredient information required on the label by Section 15(e) of the Act shall
be placed in direct conjunction with the most prominent display of the
proprietary name or designation. The prominence of the quantitative ingredient
information shall bear a reasonable relationship to the prominence of the
proprietary name.
2) If the drug is
packaged in a container too small to bear the quantitative ingredient
information on the main display panel, the quantitative ingredient information
required by Section 15(e) of the Act may appear elsewhere on the label, even
thought the proprietary name or designation appears on the main display panel
of the label; but side-or-back-panel placement shall in this case be so
arranged and printed as to provide size and prominence of display reasonably
related to the size and prominence of the front-panel display.
ee) A drug packaged in a container
too small or otherwise unable to accommodate a label with sufficient space to
bear the information required for compliance with Section 15(e)(1)(ii) of the
Act shall be exempt from compliance with those clauses; Provided that:
1) The label bears:
A) The proprietary name of the
drug;
B) The established name, if
such there be, of the drug;
C) An
identifying lot or control number; and
D) The name of the manufacturer, packer or
distributor of the drug; AND
2) All the information required to appear on
the label by the Act and the regulations promulgated thereunder appears on the
carton or other outer container or wrapper if such carton, outer container or
wrapper has sufficient space to bear such information, or such complete label
information appears on a leaflet with the package.
ff) Prescription: Drug Advertisements.
All advertisements for prescription drugs shall be subject to
all regulations issued under the
gg) An advertisement issued or caused to be
issued by the manufacturer, packer or distributor of the drug promoted by the
advertisement and which is not in compliance with Section 502(n) of the Federal
Food, Drug and Cosmetic Act (the Federal Act ), as amended (
21 U.S.C.
352) , and the applicable regulations
thereunder shall cause stocks of such drug in possession of the person
responsible for issuing or causing the issuance of the advertisement, and
stocks of the drug distributed by such person and still in the channels of
commerce, to be misbranded under Section 15(n) of the Act .
hh) Brochures, mailing pieces, detailing
pieces, file cards, bulletins, price lists, catalogs, house organs, literature
reprints and similar pieces of printed matter concerning a drug and which are
disseminated by or on behalf of its manufacturer, packer or distributor,
including reference publications for use by medical practitioners, pharmacists
or nurses, containing drug information supplied by the manufacturer, packer or
distributor of the drug, are regarded as labeling not subject to Section 15(n)
of the Act but subject to the labeling requirement of subsections (w) through
(ee) inclusive and subsections (ii) through (vv) inclusive of this
Section.
ii) Drugs and Devices:
Directions For Use.
1) Statements of all
conditions, purposes or uses for which such drug or device is intended,
including conditions, purposes or uses for which it is prescribed, recommended
or suggested in its oral, written, printed or graphic advertising, and
conditions, purposes or uses for which the drug or device is commonly used;
except that such statements shall not refer to conditions, uses or purposes for
which the drug or device can be safely used only under the supervision of a
practitioner licensed by law and for which it is advertised solely to such
practitioner.
2) Quantity of dose
(including usual quantities for each of the uses for which it is intended and
usual quantities for persons of different ages and different physical
conditions).
3) Frequency of
administration or application.
4)
Duration of administration or application.
5) Time of administration or application (in
relation to time of meals, time of onset of symptoms, or other time
factors).
6) Route of method of
administration or application.
7)
Preparation for use (shaking, dilution, adjustment of temperature, or other
manipulation or process).
jj) Exemption for Prescription Drugs.
A drug subject to the requirements of Section 16(a) of the
1) The drug is:
A)
i) In
the possession of a person (or his agents or employees) regularly and lawfully
engaged in the manufacture, transportation, storage or wholesale distribution
of prescription drugs; or
ii) In
the possession of a retail, hospital or clinic pharmacy, or a public health
agency, regularly and lawfully engaged in dispensing prescription drugs;
or
iii) In the possession of a
practitioner licensed by law to administer or prescribe such drugs;
and
B) It is to be
dispensed in accordance with Section 16 of the Act .
2) The label of the drug bears:
A) The statement "Caution: Federal law
prohibits dispensing without prescription" or "Caution: State law prohibits
dispensing without prescription"; and
B) The recommended or usual dosage;
and
C) The route of administration,
if it is not for oral use; and
D)
The quantity or proportion of each active ingredient, as well as the
information required by Section 15(d) and (e) of the Act ; and
E) If it is for other than oral use, the
names of all inactive ingredients, except that:
i) Flavorings and perfumes may be designated
as such without naming their components;
ii) Color additives may be designated as
coloring without naming specific color components unless the naming of such
components is required by a color additive regulation adopted under the Federal
Act ;
iii) Trace amounts of harmless
substances added solely for individual product identification need not be
named;
F) If it is
intended for administration by parenteral injection, the quantity of proportion
of all inactive ingredients, except that ingredients added to adjust the pH or
to make the drug isotonic may be declared by name and a statement of their
effect; and if the vehicle is water for injection it need not be
named;
G) An identifying lot or
control number from which it is possible to determine the complete
manufacturing history of the package of the drug;
H) Provided, however, that in the case of
containers too small or otherwise unable to accommodate a label with sufficient
space to bear all such information, but which are packaged within an outer
container from which they are removed for dispensing or use, the information
required by subsections (jj)(2)(B), (C) and (E) above may be contained in other
labeling on or within the package from which it is to be dispensed, and the
information referred to in subsection (jj)(2)(A) above may be placed on such
outer container only, and the information required by subsection (jj)(2)(G)
above may be on the crimp of the dispensing tube.
3)
A)
Labeling on or within the package from which the drug is to be dispensed bears
adequate information for its use, including indications, effects, dosages,
routes, methods, and frequency and duration of administrations, and any
relevant hazards, contraindications, side effects and precautions under which
practitioners licensed by law to administer the drug can use the drug safely
and for the purpose for which it is intended, including all purposes for which
it is advertised or represented; and
B) If the article is subject to Section 17 of
the Act or Section 506 or 507 of the Federal Act , the labeling bearing such
information is the labeling authorized by the approved new-drug application or
required as a condition for the certification or the exemption from
certification requirements applicable to preparations of insulin or antibiotic
drugs: Provided, however, that the information required by subsection
(jj)(3)(A) above may be omitted from the dispensing package if, but only if,
the article is a drug for which directions, hazards, warnings, and use
information are commonly known to practitioners licensed by law to administer
the drug. Upon written request, stating reasonable grounds therefor, the
Director will offer an opinion on a proposal to omit such information from the
dispensing package under this proviso.
4) Any labeling , as defined in Section
1.10
of the Act , whether or not it is on or within a package from which the drug is
to be dispensed, distributed by or on behalf of the manufacturer, packer or
distributor of the drug, that furnishes or purports to furnish information for
use or which prescribes, recommends or suggests a dosage for the use of the
drug (other than dose information required by subsection (jj)(2)(B) and
subsection (kk) of this Section) contains:
A)
Adequate information for such use, including indications, effects, dosages,
routes, methods, and frequency and duration of administration and any relevant
hazards, contraindications, side effects and precautions, under which
practitioners licensed by law to administer the drug can use the drug safely
and for the purposes for which it is intended, including all conditions for
which it is advertised or represented; and if the article is subject to Section
15 of the Act or Section 506 or 507 of the Federal Act , the labeling providing
such information is substantially the same as the labeling authorized by the
approved new-drug application or required as a condition for its certification,
or exemption from certification; and
B) The same information concerning the
ingredients of the drug as appears on the label and labeling on or within the
package from which the drug is to be dispensed; Provided, however, that the
information required by subsections (jj)(4)(A) and (B) of this Section is not
required on the so-called reminder-piece labeling which calls attention to the
name of the drug but does not include indications or dosage recommendations for
use of the drug.
5) All
labeling , except labels and cartons, bearing information for use of the drug
also bears the date of the issuance or the date of the latest revision of such
labeling .
kk) Exemption
for Veterinary Drugs.
A drug intended for veterinary use which, because of toxicity
or other potentiality for harmful effect, or the method of its use, is not
1) The drug is:
A) In the possession of a person (or his
agents or employees) regularly and lawfully engaged in the manufacture,
transportation, storage or wholesale or retail distribution of veterinary drugs
and is to be sold only to or on the prescription or other order of a licensed
veterinarian for use in the course of his professional practice; or
B) In the possession of a licensed
veterinarian for use in the course of his professional practice.
2) The label of the drug bears:
A) The statement "Caution: Federal law
restricts this drug to sale by or on the order of a licensed veterinarian" or
"Caution: State law restricts this drug to sale by or on the order of a
licensed veterinarian"; and
B) The
recommended or usual dosage; and
C)
The route of administration, if it is not for oral use; and
D) The quantity or proportion of each active
ingredient as well as the information required by Section 15(e) of the Act ;
and
E) If it is for other than oral
use, the names of all inactive ingredients, except that:
i) Flavorings and perfumes may be designated
as such without naming their components;
ii) Color additives may be designated as
coloring without naming specific color components unless the naming of such
components is required by a color additive regulation adopted under the Federal
Act ;
iii) Trace amounts of harmless
substances added solely for individual product identification need not be
named;
F) If it is
intended for administration by parenteral injection, the quantity of proportion
of all inactive ingredients, except that ingredients added to adjust the pH or
to make the drug isotonic may be declared by name and a statement of their
effect; and if the vehicle is water for injection it need not be
named;
G) An identifying lot or
control number from which it is possible to determine the complete
manufacturing history of the package of the drug; Provided, however, that in
the case of containers too small or otherwise unable to accommodate a label
with sufficient space to bear all such information, but which are packaged
within an outer container from which they are removed for dispensing or use,
the information required by subsections (kk)(2)(B), (C) and (E) above may be
contained in other labeling on or within the package from which it is to be so
dispensed, and the information referred to in subsection (kk)(2)(A) above may
be placed on such outer container only, and the information required by this
subsection (kk)(2)(G) may be on the crimp of the dispensing tube.
3)
A) Labeling on or within the package from
which the drug is to be dispensed bears adequate information for its use,
including indications, effects, dosages, routes, methods, and frequency and
duration of administrations, and any relevant hazards, contraindications, side
effects and precautions under which veterinarians licensed by law to administer
the drug can use the drug safely and for the purpose for which it is intended,
including all purposes for which it is advertised or represented; and
B) If the article is subject to Section 17 of
the Act or Section 507 of the Federal Act , the labeling bearing such
information is the labeling authorized by the approved new-drug application or
required as a condition for the certification or the exemption from
certification requirements applicable to preparations of antibiotic drugs:
Provided, however, that the information required by subsection (kk)(3)(A) above
may be omitted from the dispensing package if, but only if, the article is a
drug for which directions, hazards, warnings, and use information are commonly
known to veterinarians licensed by law to administer the drug. Upon written
request, stating reasonable grounds therefor, the Director will offer an
opinion on a proposal to omit such information from the dispensing package
under this proviso.
4)
Any labeling , as defined in Section 2.10 of the Act , whether or not it is on or
within a package from which the drug is to be dispensed, distributed by or on
behalf of the manufacturer, packer or distributor of the drug, that furnishes
or purports to furnish information for use or which prescribes, recommends or
suggests a dosage for the use of the drug (other than dose information required
by subsection (kk)(2)(B) and subsection (ll) of this Section) contains:
A) Adequate information for such use,
including indications, effects, dosages, routes, methods, and frequency and
duration of administration and any relevant hazards, contraindications, side
effects and precautions, and including information relevant to compliance with
the food additive provisions of the Act , under which veterinarians licensed by
law to administer the drug can use the drug safely and for the purposes for
which it is intended, including all conditions for which it is advertised or
represented; and if the article is subject to Section 17 of the Act or Section
507 of the Federal Act , the labeling providing such information is
substantially the same as the labeling authorized by the approved new-drug
application or required as a condition for its certification, or exemption from
certification; and
B) The same
information concerning the ingredients of the drug as appears on the label and
labeling on or within the package from which the drug is to be dispensed;
Provided, however, that the information required by subsections (kk)(4)(A) and
(B) of this Section is not required on the so-called reminder-piece labeling
which calls attention to the name of the drug but does not include indications
or dosage recommendations for use of the drug.
5) All labeling , except labels and cartons,
bearing information of use of the drug also bears the date of the issuance or
the date of the latest revision of such labeling .
6) A prescription drug intended for both
human and veterinary use shall comply with subsections (z) and (kk)(4) and (5)
of this Section.
ll)
Exemption for Prescription Devices.
A device which, because of any potentiality for harmful effect,
or the method of its use, or the collateral measures necessary to its use, is
not
1) The device is:
A)
i) In
the possession of a person (or his agents or employees) regularly and lawfully
engaged in the manufacture, transportation, storage or wholesale or retail
distribution of such device; or
ii)
In the possession of a practitioner, such as physicians, dentists and
veterinarians, licensed by law to use or order the use of such device;
and
B) Is to be sold
only to or on the prescription or other order of such practitioner for use in
the course of his practice.
2) The label of the device (other than
surgical instruments) bears:
A) The statement
"Caution: Federal law restricts this device to sale by or on the order of a
___________" or "Caution: State law restricts this device to sale by or on the
order of a ___________," the blank to be filled with the word "physician ,"
"dentist," "veterinarian," or with the descriptive designation of any other
practitioner licensed by law of the State to use or order the use of the
device; and
B) The method of its
application or use.
3)
Labeling on or within the package from which the device is to be dispensed
bears information for use, including indications, effects, routes, methods, and
frequency and duration of administration, and any relevant hazards,
contraindications, side effects and precautions under which practitioners
licensed by law to administer the device can use the device safely and for the
purpose for which it is intended, including all purposes for which it is
advertised or represented: Provided, however, that such information may be
omitted from the dispensing package if, but only if, the article is a device
for which directions, hazards, warnings and other information are commonly
known to practitioners licensed by law to use the device. Upon written request,
stating reasonable grounds therefor, the Director will offer an opinion on a
proposal to omit such information from the dispensing package under this
proviso.
4) Any labeling , as
defined in Section 2.10 of the Act , whether or not it is on or within a package
from which the device is to be dispensed, distributed by or on behalf of the
manufacturer, packer or distributor of the device, that furnishes or purports
to furnish information for use of the device contains adequate information for
such use, including indications, effects, routes, methods, and frequency and
duration of administration and any relevant hazards, contraindications, side
effects and precautions, under which practitioners licensed by law to employ
the device can use the device safely and for the purpose for which it is
intended, including all purposes for which it is advertised or represented.
This information will not be required on so-called reminder-piece labeling
which calls attention to the name of the device but does not include
indications or other use information.
5) All labeling , except labels and cartons,
bearing information for use of the device also bears the date of the issuance
or the date of the latest revision of such labeling .
mm) Exemption for Retail Veterinary Drugs and
Prescription Devices.
A drug or device subject to subsections (kk) or (ll) of this
Section shall be exempt at the time of delivery to the ultimate purchaser or
user from Section 15(f)(1) of the
nn) Exemption for
New Drugs.
A new drug shall be exempt from Section 15(f)(1) of the
1) To the extent to which such
exemption is claimed in an approved application with respect to such drug under
Section 17 of the Act ; or
2)
A) If no application under Section 17 of the
Act is approved with respect to such drug but it complies with Section 505(i)
of the Federal Act and regulations thereunder.
B) No exemption shall apply to any other drug
which would be a new drug if its labeling bore representations for its intended
use.
oo)
Exemption For Drugs or Devices When Directions Are Commonly Known.
A drug or device shall be exempt from Section 15(f)(1) of the
pp)
Exemptions For Inactive Ingredients.
A harmless drug that is ordinarily used as an inactive
ingredient, such as coloring, emulsifier, excipient, flavoring, lubricant,
preservative or solvent, in the preparation of other drugs, shall be exempt
from Section 15(f)(1) of the
qq) Exemption for Diagnostic
Reagents.
A drug intended solely for use in the professional diagnosis of
disease and which is generally recognized by qualified experts as useful for
that purpose shall be exempt from Section 15(f)(1) of the
rr) Exemption for Prescription
Chemicals and Other Prescription Components.
A drug prepared,
1) The drug is an official liquid
acid or official liquid alkali or is not a liquid solution, emulsion,
suspension, tablet, capsule or other dosage unit form; and
2) The label of the drug bears:
A) The statement "For prescription
compounding," and
B) If in
substantially all dosage forms in which it may be dispensed it is subject to
Section 16(a) of the Act , the statement "Caution: Federal law prohibits
dispensing without prescription" or "Caution: State law prohibits dispensing
without prescription," or
C)
i) If it is not subject to Section 16(a) of
the Act and is by custom among retail pharmacists sold in or from the
interstate package for use by consumers, "adequate directions for use" in the
conditions for which it is so sold.
ii) Provided, however, that the information
referred to in subsection (rr)(2)(C)(i) above may be contained in the labeling
on or within the package from which it is to be dispensed.
3) This exemption shall not apply
to any substance intended for use in compounding which results in a new drug,
unless an approved new-drug application covers such use of the drug in
compounding prescriptions.
ss) Exemption for Processing, Repacking or
Manufacture.
A drug in a bulk package (except tablets, capsules or other
dosage unit forms) or a device intended for processing, repacking or use in the
manufacture of another drug or device shall be exempt from Section 15(f)(1) of
the
1) An approved new-drug
application held by the person preparing the dosage form or drug for dispensing
covers the production and delivery to him of such substance; or
2) If no application is approved with respect
to such new drug, the label statement "Caution: For manufacturing, processing
or repacking" is immediately supplemented by the words "in the preparation of a
new drug limited by Federal law to investigational use" or "in the preparation
of a new drug limited by Illinois law to investigational use," and the delivery
is made for use only in the manufacture of such new drug limited to
investigation use.
tt)
Exemption For Drugs and Devices For Use in Teaching, Law Enforcement, Research
and Analysis.
A drug or device subject to subsections (jj), (kk) or (ll) of
this Section shall be exempt from Section 15(f)(1) of the
uu) Expiration of Exemptions.
1) If a shipment or delivery, or any part, of
a drug or device which is exempt under the regulations in this Section is made
to a person in whose possession the article is not exempt, or is made for any
purpose other than those specified, such exemption shall expire, with respect
to such shipment or delivery or part, at the beginning of that shipment or
delivery. The causing of an exemption to expire shall be considered an act
which results in such drug or device being misbranded unless it is disposed of
under circumstances in which it ceases to be a drug or device.
2) The exemptions conferred by subsections
(pp), (qq), (rr), (ss) and (tt) of this Section shall continue until the drugs
or devices are used for the purposes for which they are exempted, or until they
are relabeled to comply with Section 15(f)(1) of the Act . If, however, the drug
is converted, compounded or manufactured into a dosage form limited to
prescription dispensing, no exemption shall thereafter apply to the article
unless the dosage form is labeled as required by Section 16 of the Act and
subsections (jj), (kk) or (ll) of this Section.
vv) Intended Uses.
The words "intended uses" or words of similar import in
subsections (ii), (nn), (pp), (qq), (rr) and (ss) of this Section refer to the
ww) Drugs and Devices:
Exemptions.
1) Except as provided by
subsections (ww)(2) and (3) below, a shipment or other delivery of a drug or
device which is, in accordance with the practice of the trade, to be processed,
labeled or repacked in substantial quantity at an establishment other than that
where originally processed or packed, shall be exempt, during the time of
introduction into and movement in commerce and the time of holding in such
establishment, from compliance with the labeling and packaging requirements of
Sections 14(b) and 15(b), (d), (e), (f) and (g) of the Act if:
A) The person who introduced such shipment or
delivery into commerce is the operator of the establishment where such drug or
device is to be processed, labeled or repacked; or
B) In case such person is not such operator ,
such shipment or delivery is made to such establishment under a written
agreement, signed by and containing the post office addresses of such person
and such operator , and containing such specifications for the processing,
labeling or repacking, as the case may be, of such drug or device in such
establishment as will insure, if such specifications are followed, that such
drug or device will not be adulterated or misbranded within the meaning of the
Act upon completion of such processing, labeling or repacking. Such person and
such operator shall each keep a copy of such agreement until two years after
the final shipment or delivery of such drug or device from such establishment,
and shall make such copies available for inspection at any reasonable hour to
any officer or employee of the Illinois Department of Public Health who
requests them.
2) An
exemption of a shipment or other delivery of a drug or device under subsection
(ww)(1)(A) above shall, at the beginning of the act of removing such shipment
or delivery, or any part, from such establishment, become void ab initio if the
drug or device comprising such shipment, delivery, or part, is adulterated or
misbranded within the meaning of the act when so removed.
3) An exemption of a shipment or other
delivery of a drug or device under subsection (ww)(1)(B) above shall become
void ab initio with respect to the person who introduced such shipment or
delivery into commerce upon refusal by such person to make available for
inspection a copy of the agreement, as required by such subsection.
4) An exemption of a shipment or other
delivery of a drug or device under subsection (ww)(1)(B) above shall expire:
A) At the beginning of the act of removing
such shipment or delivery, or any part, from such establishment if the drug or
device comprising such shipment, delivery, or part, is adulterated or
misbranded within the meaning of the act when so removed; or
B) Upon refusal by the operator of the
establishment where such drug or device is to be processed, labeled or
repacked, to make available for inspection a copy of the agreement, as required
by such clause.
5)
Except as provided in subsections (ww)(7) and (8) below, a shipment or other
delivery of a drug which is subject to Section 507 of the Federal Act and which
is, in accordance with the practice of the trade, other than that where
originally processed or packed, shall be exempt from compliance with the
labeling requirements of Section 15(f) of the Act during the time such drug is
also exempt from the requirements of Section 15(1) of the Act .
6) Except as provided by subsections (ww)(7)
and (8) below, a shipment or other delivery of a drug which is subject to
Section 507 of the Federal Act and which is, in accordance with the practice of
the trade, to be labeled in substantial quantity at an establishment other than
that where originally processed or packed shall be exempt from compliance with
the labeling requirements of Section 15(b), (e) and (f) of the Act during the
time such drug is also exempt from the requirements of Section 15(1) of the Act
if the words, statements and other information required by Section 15(b) and
(e) of the Act appear on each shipping container of such drug.
7) In case the person who introduced such
shipment or other delivery into commerce is the operator of the establishment
where such drug is to be processed, labeled or repacked, an exemption of such
shipment or delivery under subsections (ww)(5) and (6) above shall become void
at the beginning of the act or removing such shipment or delivery or any part
from such establishment if the drug comprising such shipment, delivery, or
part, is adulterated or misbranded within the meaning of the act when so
removed.
8) In case the person who
introduced such shipment or delivery into interstate commerce is not the
operator of the establishment where such drug is to be processed, labeled or
repacked, an exemption of a shipment or other delivery of such drug under
subsections (ww)(5) and (6) above shall expire at the beginning of the act or
removing such shipment or delivery or any part from such establishment if the
drug comprising such shipment, delivery, or part, is adulterated or misbranded
within the meaning of the act when so removed.
xx) Definition of Term "Insulin."
For the purposes of Section 15(k) of the
1) The term "insulin"
as used therein means the active principle of pancreas which affects the
metabolism of carbohydrates in the animal body and which is of value in the
treatment of diabetes mellitus.
2)
The following substances, when they are intended for use in the manufacturing
of insulin-containing drugs that will subsequently be submitted for
certification, shall not be considered to be subject to certification as "drugs
composed wholly or partly of insulin":
A)
Pancreas glands; and
B) Materials
prepared from pancreas glands, such as "sale cake" and "isoelectric
precipitate," which materials must be subjected to further purification in
order to meet the standards of purity established by 21 CFR 429 of the Federal
Regulations.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.