111330. Any drug or device is misbranded if its labeling is false
or misleading in any particular.
111335. Any drug or device is misbranded if its labeling or
packaging does not conform to the requirements of Chapter 4
(commencing with Section 110290).
111340. Any drug or device is misbranded unless it bears a label
containing all of the following information:
(a) The name and place of business of the manufacturer, packer, or
distributor.
(b) An accurate statement of the quantity of the contents in terms
of weight, measure, or numerical count.
Reasonable variations from the requirements of subdivision (b)
shall be permitted. Requirements for placement and prominence of the
information and exemptions as to small packages shall be established
in accordance with regulations adopted pursuant to Section 110380.
111345. Any drug or device is misbranded if any word, statement, or
other information required by or under this part to appear on the
label or labeling is not prominently placed on the label or labeling
with conspicuousness, as compared with other words, statements,
designs, or devices in the labeling, and in terms as to render it
likely to be read and understood by the ordinary individual under
customary conditions of purchase and use.
111355. (a) Any drug is misbranded unless its label bears, to the
exclusion of any other nonproprietary name except the applicable,
systematic chemical name or the chemical formula, all of the
following information:
(1) The established name of the drug, if any.
(2) If it is fabricated from two or more ingredients, the
established name and quantity of each active ingredient, including
the kind and quantity or proportion of any alcohol, and also
including, whether active or not, the established name and quantity
or proportion of any bromides, ether, chloroform, acetanilide,
acetophenetidin, antipyrine, atropine, hyoscine, hyoscyamine,
codeine, arsenic, digitalis, digitalis glycosides, mercury, ouabain,
strophanthin, strychnine, barbituric acid, or any derivative or
preparation of any substances contained therein.
(3) For nonprescription drugs, the quantity or proportion of each
active ingredient and the established name of each inactive
ingredient in accordance with Sections 502(e)(1)(A)(ii) and (iii) of
the federal act (21 U.S.C. 352(e)(1)(A)(ii) and (iii)).
(b) The requirement for stating the quantity of the active
ingredients of any drug, including the quantity or proportion of any
alcohol, and also including, whether active or not, the quantity or
proportion of any bromides, ether, chloroform, acetanilide,
acetophenetidin, antipyrine, atropine, hyoscine, hyoscyamine,
codeine, arsenic, digitalis, digitalis glycosides, mercury, ouabain,
strophanthin, strychnine, barbituric acid, or any derivative or
preparation of any substances contained therein, shall apply to all
drugs, including prescription drugs and nonprescription drugs.
However, the requirement for declaration of quantity shall not apply
to nonprescription drugs that are also cosmetics, as defined in
Section 201(i) of the federal Food, Drug, and Cosmetic Act (21 U.S.C.
Sec. 321(i)) and that are labeled in compliance with federal
labeling requirements concerning declaration of ingredients including
active ingredients and also the quantity and proportion of any
alcohol, except that the quantity or proportion of the following
ingredients, whether active or not, shall be declared: bromides,
ether, chloroform, acetanilide, acetophenetidin, antipyrine,
atropine, hyoscine, hyoscyamine, codeine, arsenic, digitalis,
digitalis glycosides, mercury, ouabain, strophanthin, strychnine,
barbituric acid, or any derivative or preparation of any substances
contained therein. The department may exempt any nonprescription drug
from the requirement of stating the quantity of the active
ingredients, other than those specifically named in this subdivision,
upon a showing by the applicant through evidence satisfactory to the
department that the granting of the exemption will not endanger the
public health. For any prescription drug the established name of the
drug or ingredient, as the case may be, on the label and on any
labeling on which a name for the drug or ingredient is used shall be
printed prominently and in type at least half as large as that used
thereon for any proprietary name or designation for the drug or
ingredient.
The changes made in this section by Chapter 943 of the Statutes of
1978 shall not apply to any drug shipped by a manufacturer or packer
to a retailer or wholesaler before January 1, 1980. Any such drugs
so shipped shall comply with this section on and after January 1,
1981.
111360. Any drug subject to Section 111470 is misbranded unless the
manufacturer, packer, or distributor of the drug includes, in all
advertisements and other descriptive matter issued or caused to be
issued by the manufacturer, packer, or distributor with respect to
that drug, a true statement of all of the following:
(a) The established name, printed prominently and in a type at
least half as large as that used for any proprietary name of the
drug.
(b) The formula showing quantitatively each ingredient of the drug
to the extent required for labels under Section 111355.
(c) The name and place of business of the manufacturer that
produced the finished dosage form of the drug, as prescribed by
regulations issued by the department. This subdivision applies only
to advertisements or descriptive matter issued for drugs manufactured
in finished dosage form on or after April 1, 1973.
(d) Such other information, in brief summary relating to side
effects, contraindications, and effectiveness as shall be required by
regulations promulgated by the department.
Regulations relating to side effects, contraindications, and
effectiveness issued pursuant to Section 502(n) of the federal act
(21 U.S.C. Sec. 352(n)) are the regulations establishing information
requirements relating to side effects, contraindications and
effectiveness in this state. The department may, by regulation, make
other requirements relating to side effects, contraindications, and
effectiveness whether or not in accordance with the regulations
adopted under the federal act.
111365. Any drug subject to Section 111470 is misbranded unless the
established name of the prescription drug or prescription drug
ingredient is printed on the label prominently and in type at least
half as large as that used for the proprietary name or designation on
the label, labeling, or advertising.
The department may, by regulation, establish exemptions from the
requirements of this section when compliance with this section is not
considered necessary for the protection of health and safety.
111375. Any drug or device is misbranded unless its labeling bears
all of the following information:
(a) Adequate directions for use.
(b) Such adequate warnings against use in pathological conditions
or by children where its use may be dangerous to health.
(c) Adequate warning against unsafe dosage or methods or duration
of administration or application.
Warnings shall be in a manner and form as are necessary for the
protection of users.
If the department determines that any requirement of subdivision
(a), as applied to any drug or device, is not necessary for the
protection of the public health, the department may adopt regulations
exempting the drug or device from these requirements.
Any drug or device exempted under Section 502(f) of the federal
act (21 U.S.C. Sec. 352(f)) is exempt from the requirement of this
section. The department, however, may adopt any regulation including
a drug or device within, or excluding a drug or device from the
requirements of this section, whether or not the inclusion or
exclusion of the drug or device is in accord with the federal act.
111380. Any drug is misbranded if it purports to be a drug that is
recognized in an official compendium and it is not packaged and
labeled as prescribed in the official compendium. The method of
packaging, however, may be modified with the consent of the
department.
111385. Any drug or device is misbranded if the department
determines that the drug or device is liable to deterioration, unless
it is packaged in that form and manner and its label bears a
statement of the precautions, as the department, by regulation, may
require as necessary for the protection of public health. Such
regulations shall not be established for any drug or device
recognized in an official compendium, unless the department has
informed the appropriate body, charged with the revision of the
official compendium, of the need for that packaging or labeling
requirements and that body has not prescribed the requirements in a
reasonable length of time.
111390. Any drug or device is misbranded if its container is so
made, formed, or filled as to be misleading.
111395. Any drug is misbranded in any of the following cases:
(a) It is an imitation of another drug.
(b) It is offered for sale under the name of another drug.
(c) The contents of the original package have been, wholly or
partly, removed and replaced with other material in the package.
111400. Any drug or device is misbranded if it is dangerous to
health when used in the dosage, or with the frequency or duration
prescribed, recommended, or suggested in its labeling.
111415. Any drug is misbranded if it is a color additive, intended
for use in or on drugs for the purpose of coloring only and its
packaging and labeling fail to conform to the packaging and labeling
requirements adopted pursuant to Section 110090.
111420. A drug or device is misbranded if a trademark, trade name,
or other identifying mark, imprint, or device of another person, or
any likeness of the trademark, trade name, or other identifying mark,
imprint, or device of another person, has been placed on the drug or
device, or upon its container.
111425. A drug or device is misbranded if it was manufactured in
this state in an establishment not duly licensed as provided in this
part.
111430. A drug or device is misbranded if it was manufactured in an
establishment not duly registered with the Secretary of Health,
Education, and Welfare of the United States.
111435. Any drug is misbranded if its packaging or labeling is in
violation of an applicable regulation issued pursuant to Section
108685 or 108700.
111440. It is unlawful for any person to manufacture, sell,
deliver, hold, or offer for sale any drug or device that is
misbranded.
111445. It is unlawful for any person to misbrand any drug or
device.
111450. It is unlawful for any person to receive in commerce any
drug or device that is misbranded or to deliver or proffer for
delivery any drug or device.
111455. It is unlawful for any person to alter, mutilate, destroy,
obliterate, or remove the label or any part of the labeling of any
drug or device if the act results in the drug or device being
misbranded.
111460. Any drug or device intended for export shall not be deemed
to be misbranded under this part if it satisfies all of the following
requirements:
(a) It accords to the specifications of the foreign purchaser.
(b) It is not in conflict with the laws of the importing country.
(c) It is labeled on the outside of the shipping package to show
that it is intended for export.
If the article is sold or offered for sale in domestic commerce,
this section shall not exempt it from any of the provisions of this
part.
111465. A drug or device is deemed misbranded under the laws of
this state if it is subject to regulations issued by the United
States Food and Drug Administration relating to tamper-resistant
packaging, as set forth in Parts 200, 211, 314, and 800 of Volume 21
of the Code of Federal Regulations, as amended, but is not in
compliance therewith.
111470. The following drugs or devices, that are intended for use
by man, shall be sold only upon a written prescription of a
practitioner licensed by law to prescribe the drug or device, or upon
an oral prescription of the licensee that is reduced promptly to
writing and filed by the pharmacist, or by refilling the written or
oral prescription if the refilling is authorized by the prescriber
either in the original prescription or by oral order that is reduced
promptly to writing and filed by the pharmacist:
(a) A habit forming drug to which Section 111350 applies.
(b) A drug or device that, because of its toxicity or other
potentiality for harmful effect, or the method of its use, or the
collateral measures necessary to its use, is not safe for use except
under the supervision of a practitioner licensed by law to administer
the drug or device.
(c) A drug or device for which adequate directions cannot be
written for persons, who are not practitioners licensed by law to
prescribe the drug or device, for safe and effective self-medication
or treatment by those persons, who are not practitioners licensed by
law to prescribe the drug or device.
(d) A drug or device that is limited by an effective application
under Section 505 of the federal act (21 U.S.C. Sec. 355) or Section
111550 to use under the professional supervision of a practitioner
licensed by law to administer the drug or device.
If any prescription for the drug does not indicate the number of
times it may be refilled, if any, the prescription may not be
refilled unless the pharmacist obtains a new order from the
practitioner.
111475. The act of selling a drug or device contrary to Section
111470 shall be deemed to be an act that results in the drug or
device being misbranded while held for sale.
111480. Any drug or device sold by filling or refilling a written
or oral prescription of a practitioner licensed to prescribe the drug
or device shall be exempt from the labeling requirements of Sections
111335, 111340, 111350, 111355, 111360, 111365, 111375, 111380,
111385, 111395, 111415, and 111420, if the drug or device bears a
label displaying all the following:
(a) Except where the prescriber orders otherwise, either the
manufacturer's trade name of the drug, or the generic name and the
name of the manufacturer. Commonly used abbreviations may be used.
Preparations containing two or more active ingredients may be
identified by the manufacturer's trade name or the commonly used name
or the principal active ingredients.
(b) The directions for the use of the drug or device.
(c) The name of the patient(s).
(d) The name of the prescriber.
(e) The date of issue.
(f) The name, address of the furnisher, and prescription number or
other means of identifying the prescription.
(g) The strength of the drug or drugs dispensed.
(h) The quantity of the drug or drugs dispensed.
(i) The expiration date of the effectiveness of the drug or device
if the information is included on the original label of the
manufacturer of the drug or device.
If a pharmacist dispenses a prescribed drug by means of a unit
dose medication system, as defined by administrative regulation, for
a patient in a skilled nursing, intermediate care or other health
care facility, the requirements of this section will be satisfied if
the unit dose medication system contains the aforementioned
information or the information is otherwise readily available at the
time of drug administration.
The exemption shall not apply to any drug or device dispensed in
the course of the conduct of a business of dispensing drugs or
devices pursuant to diagnosis by mail, or to a drug or device
dispensed in violation of Section 111470.
111485. The department may, by regulation, remove any drug or
device subject to Sections 111350 and 111550 from the requirements of
Section 111470, when the requirements are not necessary for the
protection of the public health. Any drug removed from the
prescription requirements of the federal act by regulations adopted
pursuant to the federal act is removed from the requirements of
Section 111470. The department may, however, by regulation, continue
the applicability of Section 111470 for any drug or device, or make
these sections inapplicable to any drug or device, whether or not the
inclusion or exclusion of the drug or device is in accordance with
the regulations adopted pursuant to the federal act.
111490. (a) A drug or device that is subject to Section 111470 is
misbranded if at any time prior to dispensing, its label fails to
bear the statement "Caution: federal law prohibits dispensing without
prescription," or "Caution: state law prohibits dispensing without
prescription," or "R x only." A drug or device to which Section
111470 does not apply is misbranded if at any time prior to
dispensing its label bears the caution statement or "R x only" quoted
in the preceding sentence.
(b) A device that is subject to Section 111470 is misbranded if,
at any time prior to dispensing, its label fails to bear the
statement "Caution: federal law restricts this device to sale by or
on the order of a ____ ," the blank to be filled in with the
designation of the practitioner licensed to use or order use of the
device. A device to which Section 111470 does not apply is misbranded
if, at any time prior to dispensing, its label bears the caution
statement quoted in the preceding sentence.
111495. Nothing in this article shall be construed to relieve any
person from any requirement prescribed by or under authority of law
with respect to drugs now included or that may hereafter be included
within the classification stated in Division 10 (commencing with
Section 11000) or in the applicable federal law relating to
controlled substances.
111500. A physician, dentist, podiatrist, or veterinarian may
personally furnish his or her own patient with drugs as are necessary
in the treatment of the condition for which he or she attends the
patient provided that the drug is properly labeled to show all the
information required in Section 111480 except the prescription
number.
111505. For purposes of Section 111510, the following definitions
shall apply:
(a) "Distributor" means any corporation, person, or other entity,
not engaged in the manufacture of a legend drug product, who
distributes for resale and distribution a legend drug product under
the label of the corporation, person, or entity.
(b) "Legend drug" means any controlled substance subject to the
Federal Controlled Substances Act (Title II, P.L. 91-513) or subject
to the Uniform Controlled Substances Act, Division 10 (commencing
with Section 11000), and any drug described in Section 4211 of the
Business and Professions Code or Section 111470.
(c) "Solid dosage forms" means capsules or tablets intended for
oral administration.
(d) "Code imprint" means a series of letters or numbers assigned
by the manufacturer or distributor to a specific drug, or marks or
monograms unique to the manufacturer, distributor, or both. The
National Drug Code may be used as a code imprint.
111510. (a) No legend drug in solid dosage form may be manufactured
or distributed for sale in this state unless it is clearly marked or
imprinted with a code imprint identifying the drug and the
manufacturer or distributor of the drug. Manufacturers or
distributors who only repack an already finished dosage form of a
legend drug shall not have the responsibility to do the imprint.
(b) On or before July 1, 1982, manufacturers or distributors of
legend drugs, depending on whether the manufacturer's or distributor'
s code imprint will appear on the surface of the solid dosage form,
shall provide to the department a list of their legend drugs and the
intended code imprints. The department shall provide for the
distribution of the information required to be submitted under this
subdivision to all poison control centers in the state.
Manufacturers, distributors, and the department shall provide to any
licensed health care provider, upon request, lists of legend drugs
and code imprints provided to the department under this section, but
may charge a reasonable fee to cover copying and postage costs.
Updated lists shall be provided to the department annually or as
changes or revisions occur.
(c) The department may grant exemptions from the requirements of
this section upon application of a manufacturer or distributor
indicating size or other characteristics that render the product
impractical for the imprinting required by this section.
(d) A legend drug that does not meet the requirements is
misbranded.
(e) It is the intent of the Legislature that all legend drugs
having solid dosage forms be imprinted regardless of by whom they are
distributed.
(f) This section shall apply to all legend drugs sold in
California on or after January 1, 1983.
(g) Pharmacists, pharmacies, and licensed wholesalers shall only
be liable for knowing and willful violations of this section, except
that no liability shall accrue if the pharmacist acts pursuant to
Section 4229.5 of the Business and Professions Code.
(h) The provisions of subdivisions (a) to (g), inclusive, shall
not apply to any of the following:
(1) Drugs purchased by a pharmacy, pharmacist, or licensed
wholesaler prior to January 1, 1983, and held in stock for resale.
(2) Drugs that are the subject of an investigation pursuant to
Section 111590 or 111595.
(3) Drugs that are manufactured by or upon the order of a
practitioner licensed by law to prescribe or administer drugs and
that are to be used solely by the patient for whom prescribed.
111330. Any drug or device is misbranded if its labeling is false
or misleading in any particular.
111335. Any drug or device is misbranded if its labeling or
packaging does not conform to the requirements of Chapter 4
(commencing with Section 110290).
111340. Any drug or device is misbranded unless it bears a label
containing all of the following information:
(a) The name and place of business of the manufacturer, packer, or
distributor.
(b) An accurate statement of the quantity of the contents in terms
of weight, measure, or numerical count.
Reasonable variations from the requirements of subdivision (b)
shall be permitted. Requirements for placement and prominence of the
information and exemptions as to small packages shall be established
in accordance with regulations adopted pursuant to Section 110380.
111345. Any drug or device is misbranded if any word, statement, or
other information required by or under this part to appear on the
label or labeling is not prominently placed on the label or labeling
with conspicuousness, as compared with other words, statements,
designs, or devices in the labeling, and in terms as to render it
likely to be read and understood by the ordinary individual under
customary conditions of purchase and use.
111355. (a) Any drug is misbranded unless its label bears, to the
exclusion of any other nonproprietary name except the applicable,
systematic chemical name or the chemical formula, all of the
following information:
(1) The established name of the drug, if any.
(2) If it is fabricated from two or more ingredients, the
established name and quantity of each active ingredient, including
the kind and quantity or proportion of any alcohol, and also
including, whether active or not, the established name and quantity
or proportion of any bromides, ether, chloroform, acetanilide,
acetophenetidin, antipyrine, atropine, hyoscine, hyoscyamine,
codeine, arsenic, digitalis, digitalis glycosides, mercury, ouabain,
strophanthin, strychnine, barbituric acid, or any derivative or
preparation of any substances contained therein.
(3) For nonprescription drugs, the quantity or proportion of each
active ingredient and the established name of each inactive
ingredient in accordance with Sections 502(e)(1)(A)(ii) and (iii) of
the federal act (21 U.S.C. 352(e)(1)(A)(ii) and (iii)).
(b) The requirement for stating the quantity of the active
ingredients of any drug, including the quantity or proportion of any
alcohol, and also including, whether active or not, the quantity or
proportion of any bromides, ether, chloroform, acetanilide,
acetophenetidin, antipyrine, atropine, hyoscine, hyoscyamine,
codeine, arsenic, digitalis, digitalis glycosides, mercury, ouabain,
strophanthin, strychnine, barbituric acid, or any derivative or
preparation of any substances contained therein, shall apply to all
drugs, including prescription drugs and nonprescription drugs.
However, the requirement for declaration of quantity shall not apply
to nonprescription drugs that are also cosmetics, as defined in
Section 201(i) of the federal Food, Drug, and Cosmetic Act (21 U.S.C.
Sec. 321(i)) and that are labeled in compliance with federal
labeling requirements concerning declaration of ingredients including
active ingredients and also the quantity and proportion of any
alcohol, except that the quantity or proportion of the following
ingredients, whether active or not, shall be declared: bromides,
ether, chloroform, acetanilide, acetophenetidin, antipyrine,
atropine, hyoscine, hyoscyamine, codeine, arsenic, digitalis,
digitalis glycosides, mercury, ouabain, strophanthin, strychnine,
barbituric acid, or any derivative or preparation of any substances
contained therein. The department may exempt any nonprescription drug
from the requirement of stating the quantity of the active
ingredients, other than those specifically named in this subdivision,
upon a showing by the applicant through evidence satisfactory to the
department that the granting of the exemption will not endanger the
public health. For any prescription drug the established name of the
drug or ingredient, as the case may be, on the label and on any
labeling on which a name for the drug or ingredient is used shall be
printed prominently and in type at least half as large as that used
thereon for any proprietary name or designation for the drug or
ingredient.
The changes made in this section by Chapter 943 of the Statutes of
1978 shall not apply to any drug shipped by a manufacturer or packer
to a retailer or wholesaler before January 1, 1980. Any such drugs
so shipped shall comply with this section on and after January 1,
1981.
111360. Any drug subject to Section 111470 is misbranded unless the
manufacturer, packer, or distributor of the drug includes, in all
advertisements and other descriptive matter issued or caused to be
issued by the manufacturer, packer, or distributor with respect to
that drug, a true statement of all of the following:
(a) The established name, printed prominently and in a type at
least half as large as that used for any proprietary name of the
drug.
(b) The formula showing quantitatively each ingredient of the drug
to the extent required for labels under Section 111355.
(c) The name and place of business of the manufacturer that
produced the finished dosage form of the drug, as prescribed by
regulations issued by the department. This subdivision applies only
to advertisements or descriptive matter issued for drugs manufactured
in finished dosage form on or after April 1, 1973.
(d) Such other information, in brief summary relating to side
effects, contraindications, and effectiveness as shall be required by
regulations promulgated by the department.
Regulations relating to side effects, contraindications, and
effectiveness issued pursuant to Section 502(n) of the federal act
(21 U.S.C. Sec. 352(n)) are the regulations establishing information
requirements relating to side effects, contraindications and
effectiveness in this state. The department may, by regulation, make
other requirements relating to side effects, contraindications, and
effectiveness whether or not in accordance with the regulations
adopted under the federal act.
111365. Any drug subject to Section 111470 is misbranded unless the
established name of the prescription drug or prescription drug
ingredient is printed on the label prominently and in type at least
half as large as that used for the proprietary name or designation on
the label, labeling, or advertising.
The department may, by regulation, establish exemptions from the
requirements of this section when compliance with this section is not
considered necessary for the protection of health and safety.
111375. Any drug or device is misbranded unless its labeling bears
all of the following information:
(a) Adequate directions for use.
(b) Such adequate warnings against use in pathological conditions
or by children where its use may be dangerous to health.
(c) Adequate warning against unsafe dosage or methods or duration
of administration or application.
Warnings shall be in a manner and form as are necessary for the
protection of users.
If the department determines that any requirement of subdivision
(a), as applied to any drug or device, is not necessary for the
protection of the public health, the department may adopt regulations
exempting the drug or device from these requirements.
Any drug or device exempted under Section 502(f) of the federal
act (21 U.S.C. Sec. 352(f)) is exempt from the requirement of this
section. The department, however, may adopt any regulation including
a drug or device within, or excluding a drug or device from the
requirements of this section, whether or not the inclusion or
exclusion of the drug or device is in accord with the federal act.
111380. Any drug is misbranded if it purports to be a drug that is
recognized in an official compendium and it is not packaged and
labeled as prescribed in the official compendium. The method of
packaging, however, may be modified with the consent of the
department.
111385. Any drug or device is misbranded if the department
determines that the drug or device is liable to deterioration, unless
it is packaged in that form and manner and its label bears a
statement of the precautions, as the department, by regulation, may
require as necessary for the protection of public health. Such
regulations shall not be established for any drug or device
recognized in an official compendium, unless the department has
informed the appropriate body, charged with the revision of the
official compendium, of the need for that packaging or labeling
requirements and that body has not prescribed the requirements in a
reasonable length of time.
111390. Any drug or device is misbranded if its container is so
made, formed, or filled as to be misleading.
111395. Any drug is misbranded in any of the following cases:
(a) It is an imitation of another drug.
(b) It is offered for sale under the name of another drug.
(c) The contents of the original package have been, wholly or
partly, removed and replaced with other material in the package.
111400. Any drug or device is misbranded if it is dangerous to
health when used in the dosage, or with the frequency or duration
prescribed, recommended, or suggested in its labeling.
111415. Any drug is misbranded if it is a color additive, intended
for use in or on drugs for the purpose of coloring only and its
packaging and labeling fail to conform to the packaging and labeling
requirements adopted pursuant to Section 110090.
111420. A drug or device is misbranded if a trademark, trade name,
or other identifying mark, imprint, or device of another person, or
any likeness of the trademark, trade name, or other identifying mark,
imprint, or device of another person, has been placed on the drug or
device, or upon its container.
111425. A drug or device is misbranded if it was manufactured in
this state in an establishment not duly licensed as provided in this
part.
111430. A drug or device is misbranded if it was manufactured in an
establishment not duly registered with the Secretary of Health,
Education, and Welfare of the United States.
111435. Any drug is misbranded if its packaging or labeling is in
violation of an applicable regulation issued pursuant to Section
108685 or 108700.
111440. It is unlawful for any person to manufacture, sell,
deliver, hold, or offer for sale any drug or device that is
misbranded.
111445. It is unlawful for any person to misbrand any drug or
device.
111450. It is unlawful for any person to receive in commerce any
drug or device that is misbranded or to deliver or proffer for
delivery any drug or device.
111455. It is unlawful for any person to alter, mutilate, destroy,
obliterate, or remove the label or any part of the labeling of any
drug or device if the act results in the drug or device being
misbranded.
111460. Any drug or device intended for export shall not be deemed
to be misbranded under this part if it satisfies all of the following
requirements:
(a) It accords to the specifications of the foreign purchaser.
(b) It is not in conflict with the laws of the importing country.
(c) It is labeled on the outside of the shipping package to show
that it is intended for export.
If the article is sold or offered for sale in domestic commerce,
this section shall not exempt it from any of the provisions of this
part.
111465. A drug or device is deemed misbranded under the laws of
this state if it is subject to regulations issued by the United
States Food and Drug Administration relating to tamper-resistant
packaging, as set forth in Parts 200, 211, 314, and 800 of Volume 21
of the Code of Federal Regulations, as amended, but is not in
compliance therewith.
111470. The following drugs or devices, that are intended for use
by man, shall be sold only upon a written prescription of a
practitioner licensed by law to prescribe the drug or device, or upon
an oral prescription of the licensee that is reduced promptly to
writing and filed by the pharmacist, or by refilling the written or
oral prescription if the refilling is authorized by the prescriber
either in the original prescription or by oral order that is reduced
promptly to writing and filed by the pharmacist:
(a) A habit forming drug to which Section 111350 applies.
(b) A drug or device that, because of its toxicity or other
potentiality for harmful effect, or the method of its use, or the
collateral measures necessary to its use, is not safe for use except
under the supervision of a practitioner licensed by law to administer
the drug or device.
(c) A drug or device for which adequate directions cannot be
written for persons, who are not practitioners licensed by law to
prescribe the drug or device, for safe and effective self-medication
or treatment by those persons, who are not practitioners licensed by
law to prescribe the drug or device.
(d) A drug or device that is limited by an effective application
under Section 505 of the federal act (21 U.S.C. Sec. 355) or Section
111550 to use under the professional supervision of a practitioner
licensed by law to administer the drug or device.
If any prescription for the drug does not indicate the number of
times it may be refilled, if any, the prescription may not be
refilled unless the pharmacist obtains a new order from the
practitioner.
111475. The act of selling a drug or device contrary to Section
111470 shall be deemed to be an act that results in the drug or
device being misbranded while held for sale.
111480. Any drug or device sold by filling or refilling a written
or oral prescription of a practitioner licensed to prescribe the drug
or device shall be exempt from the labeling requirements of Sections
111335, 111340, 111350, 111355, 111360, 111365, 111375, 111380,
111385, 111395, 111415, and 111420, if the drug or device bears a
label displaying all the following:
(a) Except where the prescriber orders otherwise, either the
manufacturer's trade name of the drug, or the generic name and the
name of the manufacturer. Commonly used abbreviations may be used.
Preparations containing two or more active ingredients may be
identified by the manufacturer's trade name or the commonly used name
or the principal active ingredients.
(b) The directions for the use of the drug or device.
(c) The name of the patient(s).
(d) The name of the prescriber.
(e) The date of issue.
(f) The name, address of the furnisher, and prescription number or
other means of identifying the prescription.
(g) The strength of the drug or drugs dispensed.
(h) The quantity of the drug or drugs dispensed.
(i) The expiration date of the effectiveness of the drug or device
if the information is included on the original label of the
manufacturer of the drug or device.
If a pharmacist dispenses a prescribed drug by means of a unit
dose medication system, as defined by administrative regulation, for
a patient in a skilled nursing, intermediate care or other health
care facility, the requirements of this section will be satisfied if
the unit dose medication system contains the aforementioned
information or the information is otherwise readily available at the
time of drug administration.
The exemption shall not apply to any drug or device dispensed in
the course of the conduct of a business of dispensing drugs or
devices pursuant to diagnosis by mail, or to a drug or device
dispensed in violation of Section 111470.
111485. The department may, by regulation, remove any drug or
device subject to Sections 111350 and 111550 from the requirements of
Section 111470, when the requirements are not necessary for the
protection of the public health. Any drug removed from the
prescription requirements of the federal act by regulations adopted
pursuant to the federal act is removed from the requirements of
Section 111470. The department may, however, by regulation, continue
the applicability of Section 111470 for any drug or device, or make
these sections inapplicable to any drug or device, whether or not the
inclusion or exclusion of the drug or device is in accordance with
the regulations adopted pursuant to the federal act.
111490. (a) A drug or device that is subject to Section 111470 is
misbranded if at any time prior to dispensing, its label fails to
bear the statement "Caution: federal law prohibits dispensing without
prescription," or "Caution: state law prohibits dispensing without
prescription," or "R x only." A drug or device to which Section
111470 does not apply is misbranded if at any time prior to
dispensing its label bears the caution statement or "R x only" quoted
in the preceding sentence.
(b) A device that is subject to Section 111470 is misbranded if,
at any time prior to dispensing, its label fails to bear the
statement "Caution: federal law restricts this device to sale by or
on the order of a ____ ," the blank to be filled in with the
designation of the practitioner licensed to use or order use of the
device. A device to which Section 111470 does not apply is misbranded
if, at any time prior to dispensing, its label bears the caution
statement quoted in the preceding sentence.
111495. Nothing in this article shall be construed to relieve any
person from any requirement prescribed by or under authority of law
with respect to drugs now included or that may hereafter be included
within the classification stated in Division 10 (commencing with
Section 11000) or in the applicable federal law relating to
controlled substances.
111500. A physician, dentist, podiatrist, or veterinarian may
personally furnish his or her own patient with drugs as are necessary
in the treatment of the condition for which he or she attends the
patient provided that the drug is properly labeled to show all the
information required in Section 111480 except the prescription
number.
111505. For purposes of Section 111510, the following definitions
shall apply:
(a) "Distributor" means any corporation, person, or other entity,
not engaged in the manufacture of a legend drug product, who
distributes for resale and distribution a legend drug product under
the label of the corporation, person, or entity.
(b) "Legend drug" means any controlled substance subject to the
Federal Controlled Substances Act (Title II, P.L. 91-513) or subject
to the Uniform Controlled Substances Act, Division 10 (commencing
with Section 11000), and any drug described in Section 4211 of the
Business and Professions Code or Section 111470.
(c) "Solid dosage forms" means capsules or tablets intended for
oral administration.
(d) "Code imprint" means a series of letters or numbers assigned
by the manufacturer or distributor to a specific drug, or marks or
monograms unique to the manufacturer, distributor, or both. The
National Drug Code may be used as a code imprint.
111510. (a) No legend drug in solid dosage form may be manufactured
or distributed for sale in this state unless it is clearly marked or
imprinted with a code imprint identifying the drug and the
manufacturer or distributor of the drug. Manufacturers or
distributors who only repack an already finished dosage form of a
legend drug shall not have the responsibility to do the imprint.
(b) On or before July 1, 1982, manufacturers or distributors of
legend drugs, depending on whether the manufacturer's or distributor'
s code imprint will appear on the surface of the solid dosage form,
shall provide to the department a list of their legend drugs and the
intended code imprints. The department shall provide for the
distribution of the information required to be submitted under this
subdivision to all poison control centers in the state.
Manufacturers, distributors, and the department shall provide to any
licensed health care provider, upon request, lists of legend drugs
and code imprints provided to the department under this section, but
may charge a reasonable fee to cover copying and postage costs.
Updated lists shall be provided to the department annually or as
changes or revisions occur.
(c) The department may grant exemptions from the requirements of
this section upon application of a manufacturer or distributor
indicating size or other characteristics that render the product
impractical for the imprinting required by this section.
(d) A legend drug that does not meet the requirements is
misbranded.
(e) It is the intent of the Legislature that all legend drugs
having solid dosage forms be imprinted regardless of by whom they are
distributed.
(f) This section shall apply to all legend drugs sold in
California on or after January 1, 1983.
(g) Pharmacists, pharmacies, and licensed wholesalers shall only
be liable for knowing and willful violations of this section, except
that no liability shall accrue if the pharmacist acts pursuant to
Section 4229.5 of the Business and Professions Code.
(h) The provisions of subdivisions (a) to (g), inclusive, shall
not apply to any of the following:
(1) Drugs purchased by a pharmacy, pharmacist, or licensed
wholesaler prior to January 1, 1983, and held in stock for resale.
(2) Drugs that are the subject of an investigation pursuant to
Section 111590 or 111595.
(3) Drugs that are manufactured by or upon the order of a
practitioner licensed by law to prescribe or administer drugs and
that are to be used solely by the patient for whom prescribed.
111330. Any drug or device is misbranded if its labeling is false
or misleading in any particular.
111335. Any drug or device is misbranded if its labeling or
packaging does not conform to the requirements of Chapter 4
(commencing with Section 110290).
111340. Any drug or device is misbranded unless it bears a label
containing all of the following information:
(a) The name and place of business of the manufacturer, packer, or
distributor.
(b) An accurate statement of the quantity of the contents in terms
of weight, measure, or numerical count.
Reasonable variations from the requirements of subdivision (b)
shall be permitted. Requirements for placement and prominence of the
information and exemptions as to small packages shall be established
in accordance with regulations adopted pursuant to Section 110380.
111345. Any drug or device is misbranded if any word, statement, or
other information required by or under this part to appear on the
label or labeling is not prominently placed on the label or labeling
with conspicuousness, as compared with other words, statements,
designs, or devices in the labeling, and in terms as to render it
likely to be read and understood by the ordinary individual under
customary conditions of purchase and use.
111355. (a) Any drug is misbranded unless its label bears, to the
exclusion of any other nonproprietary name except the applicable,
systematic chemical name or the chemical formula, all of the
following information:
(1) The established name of the drug, if any.
(2) If it is fabricated from two or more ingredients, the
established name and quantity of each active ingredient, including
the kind and quantity or proportion of any alcohol, and also
including, whether active or not, the established name and quantity
or proportion of any bromides, ether, chloroform, acetanilide,
acetophenetidin, antipyrine, atropine, hyoscine, hyoscyamine,
codeine, arsenic, digitalis, digitalis glycosides, mercury, ouabain,
strophanthin, strychnine, barbituric acid, or any derivative or
preparation of any substances contained therein.
(3) For nonprescription drugs, the quantity or proportion of each
active ingredient and the established name of each inactive
ingredient in accordance with Sections 502(e)(1)(A)(ii) and (iii) of
the federal act (21 U.S.C. 352(e)(1)(A)(ii) and (iii)).
(b) The requirement for stating the quantity of the active
ingredients of any drug, including the quantity or proportion of any
alcohol, and also including, whether active or not, the quantity or
proportion of any bromides, ether, chloroform, acetanilide,
acetophenetidin, antipyrine, atropine, hyoscine, hyoscyamine,
codeine, arsenic, digitalis, digitalis glycosides, mercury, ouabain,
strophanthin, strychnine, barbituric acid, or any derivative or
preparation of any substances contained therein, shall apply to all
drugs, including prescription drugs and nonprescription drugs.
However, the requirement for declaration of quantity shall not apply
to nonprescription drugs that are also cosmetics, as defined in
Section 201(i) of the federal Food, Drug, and Cosmetic Act (21 U.S.C.
Sec. 321(i)) and that are labeled in compliance with federal
labeling requirements concerning declaration of ingredients including
active ingredients and also the quantity and proportion of any
alcohol, except that the quantity or proportion of the following
ingredients, whether active or not, shall be declared: bromides,
ether, chloroform, acetanilide, acetophenetidin, antipyrine,
atropine, hyoscine, hyoscyamine, codeine, arsenic, digitalis,
digitalis glycosides, mercury, ouabain, strophanthin, strychnine,
barbituric acid, or any derivative or preparation of any substances
contained therein. The department may exempt any nonprescription drug
from the requirement of stating the quantity of the active
ingredients, other than those specifically named in this subdivision,
upon a showing by the applicant through evidence satisfactory to the
department that the granting of the exemption will not endanger the
public health. For any prescription drug the established name of the
drug or ingredient, as the case may be, on the label and on any
labeling on which a name for the drug or ingredient is used shall be
printed prominently and in type at least half as large as that used
thereon for any proprietary name or designation for the drug or
ingredient.
The changes made in this section by Chapter 943 of the Statutes of
1978 shall not apply to any drug shipped by a manufacturer or packer
to a retailer or wholesaler before January 1, 1980. Any such drugs
so shipped shall comply with this section on and after January 1,
1981.
111360. Any drug subject to Section 111470 is misbranded unless the
manufacturer, packer, or distributor of the drug includes, in all
advertisements and other descriptive matter issued or caused to be
issued by the manufacturer, packer, or distributor with respect to
that drug, a true statement of all of the following:
(a) The established name, printed prominently and in a type at
least half as large as that used for any proprietary name of the
drug.
(b) The formula showing quantitatively each ingredient of the drug
to the extent required for labels under Section 111355.
(c) The name and place of business of the manufacturer that
produced the finished dosage form of the drug, as prescribed by
regulations issued by the department. This subdivision applies only
to advertisements or descriptive matter issued for drugs manufactured
in finished dosage form on or after April 1, 1973.
(d) Such other information, in brief summary relating to side
effects, contraindications, and effectiveness as shall be required by
regulations promulgated by the department.
Regulations relating to side effects, contraindications, and
effectiveness issued pursuant to Section 502(n) of the federal act
(21 U.S.C. Sec. 352(n)) are the regulations establishing information
requirements relating to side effects, contraindications and
effectiveness in this state. The department may, by regulation, make
other requirements relating to side effects, contraindications, and
effectiveness whether or not in accordance with the regulations
adopted under the federal act.
111365. Any drug subject to Section 111470 is misbranded unless the
established name of the prescription drug or prescription drug
ingredient is printed on the label prominently and in type at least
half as large as that used for the proprietary name or designation on
the label, labeling, or advertising.
The department may, by regulation, establish exemptions from the
requirements of this section when compliance with this section is not
considered necessary for the protection of health and safety.
111375. Any drug or device is misbranded unless its labeling bears
all of the following information:
(a) Adequate directions for use.
(b) Such adequate warnings against use in pathological conditions
or by children where its use may be dangerous to health.
(c) Adequate warning against unsafe dosage or methods or duration
of administration or application.
Warnings shall be in a manner and form as are necessary for the
protection of users.
If the department determines that any requirement of subdivision
(a), as applied to any drug or device, is not necessary for the
protection of the public health, the department may adopt regulations
exempting the drug or device from these requirements.
Any drug or device exempted under Section 502(f) of the federal
act (21 U.S.C. Sec. 352(f)) is exempt from the requirement of this
section. The department, however, may adopt any regulation including
a drug or device within, or excluding a drug or device from the
requirements of this section, whether or not the inclusion or
exclusion of the drug or device is in accord with the federal act.
111380. Any drug is misbranded if it purports to be a drug that is
recognized in an official compendium and it is not packaged and
labeled as prescribed in the official compendium. The method of
packaging, however, may be modified with the consent of the
department.
111385. Any drug or device is misbranded if the department
determines that the drug or device is liable to deterioration, unless
it is packaged in that form and manner and its label bears a
statement of the precautions, as the department, by regulation, may
require as necessary for the protection of public health. Such
regulations shall not be established for any drug or device
recognized in an official compendium, unless the department has
informed the appropriate body, charged with the revision of the
official compendium, of the need for that packaging or labeling
requirements and that body has not prescribed the requirements in a
reasonable length of time.
111390. Any drug or device is misbranded if its container is so
made, formed, or filled as to be misleading.
111395. Any drug is misbranded in any of the following cases:
(a) It is an imitation of another drug.
(b) It is offered for sale under the name of another drug.
(c) The contents of the original package have been, wholly or
partly, removed and replaced with other material in the package.
111400. Any drug or device is misbranded if it is dangerous to
health when used in the dosage, or with the frequency or duration
prescribed, recommended, or suggested in its labeling.
111415. Any drug is misbranded if it is a color additive, intended
for use in or on drugs for the purpose of coloring only and its
packaging and labeling fail to conform to the packaging and labeling
requirements adopted pursuant to Section 110090.
111420. A drug or device is misbranded if a trademark, trade name,
or other identifying mark, imprint, or device of another person, or
any likeness of the trademark, trade name, or other identifying mark,
imprint, or device of another person, has been placed on the drug or
device, or upon its container.
111425. A drug or device is misbranded if it was manufactured in
this state in an establishment not duly licensed as provided in this
part.
111430. A drug or device is misbranded if it was manufactured in an
establishment not duly registered with the Secretary of Health,
Education, and Welfare of the United States.
111435. Any drug is misbranded if its packaging or labeling is in
violation of an applicable regulation issued pursuant to Section
108685 or 108700.
111440. It is unlawful for any person to manufacture, sell,
deliver, hold, or offer for sale any drug or device that is
misbranded.
111445. It is unlawful for any person to misbrand any drug or
device.
111450. It is unlawful for any person to receive in commerce any
drug or device that is misbranded or to deliver or proffer for
delivery any drug or device.
111455. It is unlawful for any person to alter, mutilate, destroy,
obliterate, or remove the label or any part of the labeling of any
drug or device if the act results in the drug or device being
misbranded.
111460. Any drug or device intended for export shall not be deemed
to be misbranded under this part if it satisfies all of the following
requirements:
(a) It accords to the specifications of the foreign purchaser.
(b) It is not in conflict with the laws of the importing country.
(c) It is labeled on the outside of the shipping package to show
that it is intended for export.
If the article is sold or offered for sale in domestic commerce,
this section shall not exempt it from any of the provisions of this
part.
111465. A drug or device is deemed misbranded under the laws of
this state if it is subject to regulations issued by the United
States Food and Drug Administration relating to tamper-resistant
packaging, as set forth in Parts 200, 211, 314, and 800 of Volume 21
of the Code of Federal Regulations, as amended, but is not in
compliance therewith.
111470. The following drugs or devices, that are intended for use
by man, shall be sold only upon a written prescription of a
practitioner licensed by law to prescribe the drug or device, or upon
an oral prescription of the licensee that is reduced promptly to
writing and filed by the pharmacist, or by refilling the written or
oral prescription if the refilling is authorized by the prescriber
either in the original prescription or by oral order that is reduced
promptly to writing and filed by the pharmacist:
(a) A habit forming drug to which Section 111350 applies.
(b) A drug or device that, because of its toxicity or other
potentiality for harmful effect, or the method of its use, or the
collateral measures necessary to its use, is not safe for use except
under the supervision of a practitioner licensed by law to administer
the drug or device.
(c) A drug or device for which adequate directions cannot be
written for persons, who are not practitioners licensed by law to
prescribe the drug or device, for safe and effective self-medication
or treatment by those persons, who are not practitioners licensed by
law to prescribe the drug or device.
(d) A drug or device that is limited by an effective application
under Section 505 of the federal act (21 U.S.C. Sec. 355) or Section
111550 to use under the professional supervision of a practitioner
licensed by law to administer the drug or device.
If any prescription for the drug does not indicate the number of
times it may be refilled, if any, the prescription may not be
refilled unless the pharmacist obtains a new order from the
practitioner.
111475. The act of selling a drug or device contrary to Section
111470 shall be deemed to be an act that results in the drug or
device being misbranded while held for sale.
111480. Any drug or device sold by filling or refilling a written
or oral prescription of a practitioner licensed to prescribe the drug
or device shall be exempt from the labeling requirements of Sections
111335, 111340, 111350, 111355, 111360, 111365, 111375, 111380,
111385, 111395, 111415, and 111420, if the drug or device bears a
label displaying all the following:
(a) Except where the prescriber orders otherwise, either the
manufacturer's trade name of the drug, or the generic name and the
name of the manufacturer. Commonly used abbreviations may be used.
Preparations containing two or more active ingredients may be
identified by the manufacturer's trade name or the commonly used name
or the principal active ingredients.
(b) The directions for the use of the drug or device.
(c) The name of the patient(s).
(d) The name of the prescriber.
(e) The date of issue.
(f) The name, address of the furnisher, and prescription number or
other means of identifying the prescription.
(g) The strength of the drug or drugs dispensed.
(h) The quantity of the drug or drugs dispensed.
(i) The expiration date of the effectiveness of the drug or device
if the information is included on the original label of the
manufacturer of the drug or device.
If a pharmacist dispenses a prescribed drug by means of a unit
dose medication system, as defined by administrative regulation, for
a patient in a skilled nursing, intermediate care or other health
care facility, the requirements of this section will be satisfied if
the unit dose medication system contains the aforementioned
information or the information is otherwise readily available at the
time of drug administration.
The exemption shall not apply to any drug or device dispensed in
the course of the conduct of a business of dispensing drugs or
devices pursuant to diagnosis by mail, or to a drug or device
dispensed in violation of Section 111470.
111485. The department may, by regulation, remove any drug or
device subject to Sections 111350 and 111550 from the requirements of
Section 111470, when the requirements are not necessary for the
protection of the public health. Any drug removed from the
prescription requirements of the federal act by regulations adopted
pursuant to the federal act is removed from the requirements of
Section 111470. The department may, however, by regulation, continue
the applicability of Section 111470 for any drug or device, or make
these sections inapplicable to any drug or device, whether or not the
inclusion or exclusion of the drug or device is in accordance with
the regulations adopted pursuant to the federal act.
111490. (a) A drug or device that is subject to Section 111470 is
misbranded if at any time prior to dispensing, its label fails to
bear the statement "Caution: federal law prohibits dispensing without
prescription," or "Caution: state law prohibits dispensing without
prescription," or "R x only." A drug or device to which Section
111470 does not apply is misbranded if at any time prior to
dispensing its label bears the caution statement or "R x only" quoted
in the preceding sentence.
(b) A device that is subject to Section 111470 is misbranded if,
at any time prior to dispensing, its label fails to bear the
statement "Caution: federal law restricts this device to sale by or
on the order of a ____ ," the blank to be filled in with the
designation of the practitioner licensed to use or order use of the
device. A device to which Section 111470 does not apply is misbranded
if, at any time prior to dispensing, its label bears the caution
statement quoted in the preceding sentence.
111495. Nothing in this article shall be construed to relieve any
person from any requirement prescribed by or under authority of law
with respect to drugs now included or that may hereafter be included
within the classification stated in Division 10 (commencing with
Section 11000) or in the applicable federal law relating to
controlled substances.
111500. A physician, dentist, podiatrist, or veterinarian may
personally furnish his or her own patient with drugs as are necessary
in the treatment of the condition for which he or she attends the
patient provided that the drug is properly labeled to show all the
information required in Section 111480 except the prescription
number.
111505. For purposes of Section 111510, the following definitions
shall apply:
(a) "Distributor" means any corporation, person, or other entity,
not engaged in the manufacture of a legend drug product, who
distributes for resale and distribution a legend drug product under
the label of the corporation, person, or entity.
(b) "Legend drug" means any controlled substance subject to the
Federal Controlled Substances Act (Title II, P.L. 91-513) or subject
to the Uniform Controlled Substances Act, Division 10 (commencing
with Section 11000), and any drug described in Section 4211 of the
Business and Professions Code or Section 111470.
(c) "Solid dosage forms" means capsules or tablets intended for
oral administration.
(d) "Code imprint" means a series of letters or numbers assigned
by the manufacturer or distributor to a specific drug, or marks or
monograms unique to the manufacturer, distributor, or both. The
National Drug Code may be used as a code imprint.
111510. (a) No legend drug in solid dosage form may be manufactured
or distributed for sale in this state unless it is clearly marked or
imprinted with a code imprint identifying the drug and the
manufacturer or distributor of the drug. Manufacturers or
distributors who only repack an already finished dosage form of a
legend drug shall not have the responsibility to do the imprint.
(b) On or before July 1, 1982, manufacturers or distributors of
legend drugs, depending on whether the manufacturer's or distributor'
s code imprint will appear on the surface of the solid dosage form,
shall provide to the department a list of their legend drugs and the
intended code imprints. The department shall provide for the
distribution of the information required to be submitted under this
subdivision to all poison control centers in the state.
Manufacturers, distributors, and the department shall provide to any
licensed health care provider, upon request, lists of legend drugs
and code imprints provided to the department under this section, but
may charge a reasonable fee to cover copying and postage costs.
Updated lists shall be provided to the department annually or as
changes or revisions occur.
(c) The department may grant exemptions from the requirements of
this section upon application of a manufacturer or distributor
indicating size or other characteristics that render the product
impractical for the imprinting required by this section.
(d) A legend drug that does not meet the requirements is
misbranded.
(e) It is the intent of the Legislature that all legend drugs
having solid dosage forms be imprinted regardless of by whom they are
distributed.
(f) This section shall apply to all legend drugs sold in
California on or after January 1, 1983.
(g) Pharmacists, pharmacies, and licensed wholesalers shall only
be liable for knowing and willful violations of this section, except
that no liability shall accrue if the pharmacist acts pursuant to
Section 4229.5 of the Business and Professions Code.
(h) The provisions of subdivisions (a) to (g), inclusive, shall
not apply to any of the following:
(1) Drugs purchased by a pharmacy, pharmacist, or licensed
wholesaler prior to January 1, 1983, and held in stock for resale.
(2) Drugs that are the subject of an investigation pursuant to
Section 111590 or 111595.
(3) Drugs that are manufactured by or upon the order of a
practitioner licensed by law to prescribe or administer drugs and
that are to be used solely by the patient for whom prescribed.
