Section 720.50 Drugs and Devices

Section 720

Section 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 labeling of a drug or device which render such drug or

device misbranded is a false or misleading representation with respect to

another drug or device or a food or cosmetic.

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 person whose name appear on the label, the

name shall be qualified by a phrase which reveals the connection such person

has with such drug or device, such as "Manufactured for and Packed by ____________,"

"Distributed by ____________," or other similar phrase which

expresses the facts.

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

reveals the connection such person

has with such drug or device, such as "Manufactured for and Packed by ____________,"

"Distributed by ____________," or other similar phrase which

expresses the facts.

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

ntity 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 68º

Fahrenheit (20º 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

Fahrenheit (20º 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, 1¼ 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 "1½ 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

" 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

troduced 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

ections (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 Act to

appear on the label may lack that prominence and conspicuousness required by

Section 15(c) of the Act by reason (among other reasons) of:

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 packa

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

y:

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 Act shall appear together, without

any intervening written, printed or graphic matter, except the proprietary

names of ingredients, which may be included with the listing of established

names, and such statements as "Warning – May be Habit Forming" that

are specifically required for certain ingredients by the Act or regulations

promulgated thereunder.

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

redients, which may be included with the listing of established

names, and such statements as "Warning – May be Habit Forming" that

are specifically required for certain ingredients by the Act or regulations

promulgated thereunder.

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

ient 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

68º F. (20º C.), if the ingredient is a solid and the drug is a liquid; and

percent volume-in-volume at 68º F. (20º 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 60º F. (15.56º 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

volume-in-volume at 68º F. (20º 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 60º F. (15.56º 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

hall 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

ative

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 Federal Food, Drug and Cosmetic Act (the Federal Act), as

amended (21 U.S.C. 352), including all regulations relating to but not limited

to Section 502(n) of such Federal Act.

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

s

amended (21 U.S.C. 352), including all regulations relating to but not limited

to Section 502(n) of such Federal Act.

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.

ADEQUATE

DIRECTIONS FOR USE.  "Adequate directions for use" means directions

under which the layman can use a drug or device safely and for the purposes for

which it is intended

ction 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.

ADEQUATE

DIRECTIONS FOR USE.  "Adequate directions for use" means directions

under which the layman can use a drug or device safely and for the purposes for

which it is intended.  Directions for use may be inadequate because (among

other reasons) of omission, in whole or in part, or incorrect specification of:

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

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 Act shall be exempt from Section

15(f)(1) if all the following conditions are met:

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 s

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

or 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

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 o

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 safe for animal use except

under the supervision of a licensed veterinarian, and hence for which

"adequate directions for use" cannot be prepared, shall be exempt from

Section 15(f)(1) of the Act if all the following conditions are met:

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

r 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 s

onic 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 li

s 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 labe

ticle 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 safe except under

the supervision of a practitioner licensed by law to direct the use of such

device, and hence for which "adequate directions for use" cannot be

prepared, shall be exempt from Section 15(f)(1) of the Act if all the following

conditions are met:

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 cour

egularly 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

y 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

n

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 Act if it is delivered by a licensed practitioner in the course of his

professional practice or upon a prescription or other order lawfully issued in

the course of his professional practice, with labeling bearing the name and

address of such licensed practitioner and the directions for use and cautionary

statements, if any, contained in such order.

nn)       Exemption for New Drugs.

A new drug

shall be exempt from Section 15(f)(1) of the Act:

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 Act insofar as adequate

directions for common uses thereof are known to the ordinary individual.

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 Act

(f)(1) of the Act insofar as adequate

directions for common uses thereof are known to the ordinary individual.

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 Act.

This exemption shall not apply to any substance intended for a use which

results in the preparation of a new drug, unless an approved new-drug

application provides for such use.

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 Act if it label bears the statement

"Diagnostic reagent – For professional use only."

rr)        Exemption for Prescription Chemicals and Other Prescription

Components.

A drug

prepared, packaged and primarily sold as a prescription chemical or other

component for use by registered pharmacists in compounding prescriptions or for

dispensing in dosage unit form upon prescriptions shall be exempt from Section

15(f)(1) of the Act if all the following conditions are met:

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 u

ispensed 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 Act if its label bears the

statement "Caution:  For manufacture, processing or repacking" and,

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."  This exemption and the

exemption under subsection (rr) of this Section may be claimed for the same

article

processing or repacking" and,

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."  This exemption and the

exemption under subsection (rr) of this Section may be claimed for the same

article.  But the exemption shall not apply to a substance intended for a use

in manufacture, processing or repacking which causes the finished article to be

a new drug, unless:

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 Act if shipped or sold to, or in the

possession of, persons regularly and lawfully engaged in instruction in

pharmacy, chemistry or medicine not involving clinical use, or engaged in law

enforcement, or in research not involving clinical use, or in chemical

analysis, or physical testing, and is to be used only for such instruction, law

enforcement, research, analysis or testing.

uu)       Expiration of Exemptions

d to, or in the

possession of, persons regularly and lawfully engaged in instruction in

pharmacy, chemistry or medicine not involving clinical use, or engaged in law

enforcement, or in research not involving clinical use, or in chemical

analysis, or physical testing, and is to be used only for such instruction, law

enforcement, research, analysis or testing.

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 objective intent of the

persons legally responsible for the labeling of drugs and devices.  The intent

is determined by such persons' expressions or may be shown by the circumstances

surrounding the distribution of the article

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 objective intent of the

persons legally responsible for the labeling of drugs and devices.  The intent

is determined by such persons' expressions or may be shown by the circumstances

surrounding the distribution of the article.  This objective intent may, for

example, be shown by labeling claims, advertising matter, or oral or written

statements by such persons or their representatives.  It may be shown by the

circumstances that the article is, with the knowledge of such persons or their

representatives, offered and used for a purpose for which it is neither labeled

nor advertised.  The intended uses of an article may change after it has been

introduced into commerce by its manufacturer.  If, for example, a packer,

distributor or seller intends an article for different uses than those intended

by the person from whom he received the drug, such packer, distributor or

seller is required to supply adequate labeling in accordance with the new intended

uses.  But if a manufacturer knows, or has knowledge of facts that would give

him notice, that a drug or device introduced into commerce by him is to be used

for conditions, purposes or uses other than the ones for which he offers it, he

is required to provide adequate labeling for such a drug which accords with

such other uses to which the article is to be put.

ww)     Drugs and Devices:  Exemptions

But if a manufacturer knows, or has knowledge of facts that would give

him notice, that a drug or device introduced into commerce by him is to be used

for conditions, purposes or uses other than the ones for which he offers it, he

is required to provide adequate labeling for such a drug which accords with

such other uses to which the article is to be put.

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

fice 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

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

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

ment 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 Act and Section 506 of the Federal Act.

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.