State Codes and Statutes

Statutes > North-carolina > Chapter_106 > GS_106-134

§ 106‑134.  Drugsdeemed misbranded.

A drug or device shall be deemed to be misbranded:

(1)        If its labeling is false or misleading in any particular, orif its labeling or packaging fails to conform with the requirements of G.S. 106‑139or 106‑139.1 of this Article.

(2)        If in package form unless it bears a label containing

a.         The name and place of business of the manufacturer, packer,or distributor; and

b.         An accurate statement of the quantity of the contents interms of weight, measure, or numerical count, which statement shall beseparately and accurately stated in a uniform location upon the principaldisplay panel of the label, except as exempted with respect to this clause byG.S. 106‑121(2a)c of this Article; provided, that under paragraph b ofthis subdivision reasonable variations shall be permitted, and exemptions as tosmall packages shall be established, by regulations prescribed by the Board ofAgriculture.

(3)        If any word, statement, or other information required by orunder authority of this Article to appear on the label or labeling is notprominently placed thereon with such conspicuousness (as compared with otherwords, statements, designs or devices, in the labeling) and in such terms as torender it likely to be read and understood by the ordinary individual undercustomary conditions of purchase and use.

(4)        If it is for use by man and contains any quantity of thenarcotic or hypnotic substance alphaeucaine, barbituric acid, betaeucaine,bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin,marijuana, morphine, opium, paraldehyde, peyote, or sulphonmethane; or anychemical derivative of such substances, which derivative has been by the Boardafter investigation, found to be, and by regulations under this Article,designated as, habit forming; unless its label bears the name and quantity orproportion of such substance or derivative and in juxtaposition therewith thestatement "Warning – May be habit forming."

(5)        a.         If it is a drug, unless:

1.         Its label bears, to the exclusion of any othernonproprietary name (except the applicable systematic chemical name or thechemical formula),

I.          The established name (as defined in paragraph b of thissubdivision) of the drug, if such there be, and

II.         In case it is fabricated from two or more ingredients theestablished name and quantity of each active ingredient, including the kind andquantity or proportion of any alcohol and also including, whether active ornot, the established name and quantity or proportion of any bromides, ether, chloroform,acetanilid, acetphenetidin, amidopyrine, antipyrine, atropine, hyoscine,hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury, ouabain,strophanthin, strychnine, thyroid, or any derivative or preparation of any suchsubstances, contained therein: Provided, that the requirement for stating thequantity of the active ingredients, other than the quantity of thosespecifically named in this subdivision, shall apply only to prescription drugs;and

2.         For any prescription drug the established name of such drugor ingredient, as the case may be, on such label (and on any labeling on whicha name for such drug or ingredient is used) is printed prominently and in typeat least half as large as that used thereon for any proprietary name or designationfor such drug or ingredient; and provided, that to the extent that compliancewith the requirements of 1 II or 2 of this subdivision is impracticable,exemptions shall be allowed under regulations promulgated by the Board.

b.         As used in this subdivision (5), the term "establishedname," with respect to a drug or ingredient thereof, means:

1.         The applicable official name designated pursuant to section508 of the federal act, or

2.         If there is no such name and such drug, or such ingredient,is an article recognized in an official compendium, then the official titlethereof, in such compendium, or

3.         If neither 1 nor 2 of this paragraph applies, then thecommon or usual name, if any, of such drug or of such ingredient:

Provided further, that where 2 of this sub‑subdivisionapplies to an article recognized in the United States Pharmacopoeia and in theHomeopathic Pharmacopoeia under different official titles, the official titleused in the United States Pharmacopoeia shall apply unless it is labeled andoffered for sale as a homeopathic drug, in which case the official title usedin the Homeopathic Pharmacopoeia shall apply.

(6)        Unless its labeling bears

a.         Adequate directions for use; and

b.         Such adequate warnings against use in those pathologicalconditions or by children where its use may be dangerous to health, or againstunsafe dosage or methods or duration of administration or application, in suchmanner and form, as are necessary for the protection of users: Provided, thatwhere any requirement of paragraph a of this subdivision, as applied to anydrug or device, is not necessary for the protection of the public health, theBoard of Agriculture shall promulgate regulations exempting such drug or devicefrom such requirements.

(7)        If it purports to be a drug the name of which is recognizedin an official compendium, unless it is packaged and labeled as prescribedtherein: Provided, that the method of packing may be modified with the consentof the Board of Agriculture. Whenever a drug is recognized in both the UnitedStates Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States, itshall be subject to the requirements of the United States Pharmacopoeia withrespect to packaging and labeling unless it is labeled and offered for sale asa homeopathic drug, in which case it shall be subject to the provisions of theHomeopathic Pharmacopoeia of the United States and not to those of the UnitedStates Pharmacopoeia.

(8)        If it has been found by the Department of Agriculture andConsumer Services to be a drug liable to deterioration, unless it is packagedin such form and manner, and its label bears a statement of such precautions,as the Board of Agriculture shall by regulations require as necessary for theprotection of public health. No such regulation shall be established for anydrug recognized in an official compendium until the Commissioner of Agricultureshall have informed the appropriate body charged with the revision of suchcompendium of the need for such packaging or labeling requirements and suchbody shall have failed within a reasonable time to prescribe such requirements.

(9)        a.         If it is a drug and itscontainer is so made, formed, or filled as to be misleading; or

b.         If it is an imitation of another drug; or

c.         If it is offered for sale under the name of another drug.

(10)      If it is dangerous to health when used in the dosage, or withthe frequency or duration prescribed, recommended, or suggested in the labelingthereof.

(11),     (12) Repealed by Session Laws 1975, c. 614, s. 28.

(13)      If it is, or purports to be, or is represented as a drugcomposed wholly or partly of insulin, unless:

a.         It is from a batch with respect to which a certificate orrelease has been issued pursuant to section 506 of the federal act, and

b.         Such certificate or release is in effect with respect tosuch drug.

(14)      If it is, or purports to be, or is represented as a drugcomposed wholly or partly of any kind of penicillin, streptomycin,chlortetracycline, chloramphenicol, bacitracin, or any other antibiotic drug,or any derivative thereof, unless

a.         It is from a batch with respect to which a certificate orrelease has been issued pursuant to section 507 of the federal act, and

b.         Such certificate or release is in effect with respect tosuch drug:

Provided, that this subsection shall not apply to anydrug or class of drugs exempted by regulations promulgated under section 507(c)or (d) of the federal act. For the purpose of this subsection the term"antibiotic drug" means any drug intended for use by man containingany quantity of any chemical substance which is produced by microorganisms andwhich has the capacity to inhibit or destroy microorganisms in dilute solution(including the chemically synthesized equivalent of any such substance).

(15)      If it is a color additive, the intended use of which in or ondrugs is for the purpose of coloring only, unless its packaging and labelingare in conformity with such packaging and labeling requirements applicable tosuch color additive, prescribed under the provisions of G.S. 106‑132 ofthis Article.

(16)      In the case of any prescription drug distributed or offeredfor sale in this State, unless the manufacturer, packer, or distributor thereofincludes in all advertisements and other descriptive printed matter issued orcaused to be issued by the manufacturer, packer, or distributor with respect tothat drug a true statement of

a.         The established name, as defined in G.S. 106‑134(5)bof this Article, printed prominently and in type at least half as large as thatused for any trade or brand name thereof,

b.         The formula showing quantitatively each ingredient of suchdrug to the extent required for labels under section 502(e) of the federal act,and

c.         Such other information in brief summary relating to sideeffects, contraindications, and effectiveness as shall be required inregulations issued under the federal act.

(17)      If a trademark, trade name or other identifying mark, imprintor device of another or any likeness of the foregoing has been placed thereonor upon its container with intent to defraud.

(18)      If it is a drug and its packaging or labeling is in violationof an applicable regulation issued pursuant to section 3 or 4 of the FederalPoison Prevention Packaging Act of 1970. (1939, c. 320, s. 15; 1949, c. 370; 1973, c. 831, s. 1; 1975, c. 614,ss. 25‑28, 30; 1997‑261, s. 33.)

State Codes and Statutes

Statutes > North-carolina > Chapter_106 > GS_106-134

§ 106‑134.  Drugsdeemed misbranded.

A drug or device shall be deemed to be misbranded:

(1)        If its labeling is false or misleading in any particular, orif its labeling or packaging fails to conform with the requirements of G.S. 106‑139or 106‑139.1 of this Article.

(2)        If in package form unless it bears a label containing

a.         The name and place of business of the manufacturer, packer,or distributor; and

b.         An accurate statement of the quantity of the contents interms of weight, measure, or numerical count, which statement shall beseparately and accurately stated in a uniform location upon the principaldisplay panel of the label, except as exempted with respect to this clause byG.S. 106‑121(2a)c of this Article; provided, that under paragraph b ofthis subdivision reasonable variations shall be permitted, and exemptions as tosmall packages shall be established, by regulations prescribed by the Board ofAgriculture.

(3)        If any word, statement, or other information required by orunder authority of this Article to appear on the label or labeling is notprominently placed thereon with such conspicuousness (as compared with otherwords, statements, designs or devices, in the labeling) and in such terms as torender it likely to be read and understood by the ordinary individual undercustomary conditions of purchase and use.

(4)        If it is for use by man and contains any quantity of thenarcotic or hypnotic substance alphaeucaine, barbituric acid, betaeucaine,bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin,marijuana, morphine, opium, paraldehyde, peyote, or sulphonmethane; or anychemical derivative of such substances, which derivative has been by the Boardafter investigation, found to be, and by regulations under this Article,designated as, habit forming; unless its label bears the name and quantity orproportion of such substance or derivative and in juxtaposition therewith thestatement "Warning – May be habit forming."

(5)        a.         If it is a drug, unless:

1.         Its label bears, to the exclusion of any othernonproprietary name (except the applicable systematic chemical name or thechemical formula),

I.          The established name (as defined in paragraph b of thissubdivision) of the drug, if such there be, and

II.         In case it is fabricated from two or more ingredients theestablished name and quantity of each active ingredient, including the kind andquantity or proportion of any alcohol and also including, whether active ornot, the established name and quantity or proportion of any bromides, ether, chloroform,acetanilid, acetphenetidin, amidopyrine, antipyrine, atropine, hyoscine,hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury, ouabain,strophanthin, strychnine, thyroid, or any derivative or preparation of any suchsubstances, contained therein: Provided, that the requirement for stating thequantity of the active ingredients, other than the quantity of thosespecifically named in this subdivision, shall apply only to prescription drugs;and

2.         For any prescription drug the established name of such drugor ingredient, as the case may be, on such label (and on any labeling on whicha name for such drug or ingredient is used) is printed prominently and in typeat least half as large as that used thereon for any proprietary name or designationfor such drug or ingredient; and provided, that to the extent that compliancewith the requirements of 1 II or 2 of this subdivision is impracticable,exemptions shall be allowed under regulations promulgated by the Board.

b.         As used in this subdivision (5), the term "establishedname," with respect to a drug or ingredient thereof, means:

1.         The applicable official name designated pursuant to section508 of the federal act, or

2.         If there is no such name and such drug, or such ingredient,is an article recognized in an official compendium, then the official titlethereof, in such compendium, or

3.         If neither 1 nor 2 of this paragraph applies, then thecommon or usual name, if any, of such drug or of such ingredient:

Provided further, that where 2 of this sub‑subdivisionapplies to an article recognized in the United States Pharmacopoeia and in theHomeopathic Pharmacopoeia under different official titles, the official titleused in the United States Pharmacopoeia shall apply unless it is labeled andoffered for sale as a homeopathic drug, in which case the official title usedin the Homeopathic Pharmacopoeia shall apply.

(6)        Unless its labeling bears

a.         Adequate directions for use; and

b.         Such adequate warnings against use in those pathologicalconditions or by children where its use may be dangerous to health, or againstunsafe dosage or methods or duration of administration or application, in suchmanner and form, as are necessary for the protection of users: Provided, thatwhere any requirement of paragraph a of this subdivision, as applied to anydrug or device, is not necessary for the protection of the public health, theBoard of Agriculture shall promulgate regulations exempting such drug or devicefrom such requirements.

(7)        If it purports to be a drug the name of which is recognizedin an official compendium, unless it is packaged and labeled as prescribedtherein: Provided, that the method of packing may be modified with the consentof the Board of Agriculture. Whenever a drug is recognized in both the UnitedStates Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States, itshall be subject to the requirements of the United States Pharmacopoeia withrespect to packaging and labeling unless it is labeled and offered for sale asa homeopathic drug, in which case it shall be subject to the provisions of theHomeopathic Pharmacopoeia of the United States and not to those of the UnitedStates Pharmacopoeia.

(8)        If it has been found by the Department of Agriculture andConsumer Services to be a drug liable to deterioration, unless it is packagedin such form and manner, and its label bears a statement of such precautions,as the Board of Agriculture shall by regulations require as necessary for theprotection of public health. No such regulation shall be established for anydrug recognized in an official compendium until the Commissioner of Agricultureshall have informed the appropriate body charged with the revision of suchcompendium of the need for such packaging or labeling requirements and suchbody shall have failed within a reasonable time to prescribe such requirements.

(9)        a.         If it is a drug and itscontainer is so made, formed, or filled as to be misleading; or

b.         If it is an imitation of another drug; or

c.         If it is offered for sale under the name of another drug.

(10)      If it is dangerous to health when used in the dosage, or withthe frequency or duration prescribed, recommended, or suggested in the labelingthereof.

(11),     (12) Repealed by Session Laws 1975, c. 614, s. 28.

(13)      If it is, or purports to be, or is represented as a drugcomposed wholly or partly of insulin, unless:

a.         It is from a batch with respect to which a certificate orrelease has been issued pursuant to section 506 of the federal act, and

b.         Such certificate or release is in effect with respect tosuch drug.

(14)      If it is, or purports to be, or is represented as a drugcomposed wholly or partly of any kind of penicillin, streptomycin,chlortetracycline, chloramphenicol, bacitracin, or any other antibiotic drug,or any derivative thereof, unless

a.         It is from a batch with respect to which a certificate orrelease has been issued pursuant to section 507 of the federal act, and

b.         Such certificate or release is in effect with respect tosuch drug:

Provided, that this subsection shall not apply to anydrug or class of drugs exempted by regulations promulgated under section 507(c)or (d) of the federal act. For the purpose of this subsection the term"antibiotic drug" means any drug intended for use by man containingany quantity of any chemical substance which is produced by microorganisms andwhich has the capacity to inhibit or destroy microorganisms in dilute solution(including the chemically synthesized equivalent of any such substance).

(15)      If it is a color additive, the intended use of which in or ondrugs is for the purpose of coloring only, unless its packaging and labelingare in conformity with such packaging and labeling requirements applicable tosuch color additive, prescribed under the provisions of G.S. 106‑132 ofthis Article.

(16)      In the case of any prescription drug distributed or offeredfor sale in this State, unless the manufacturer, packer, or distributor thereofincludes in all advertisements and other descriptive printed matter issued orcaused to be issued by the manufacturer, packer, or distributor with respect tothat drug a true statement of

a.         The established name, as defined in G.S. 106‑134(5)bof this Article, printed prominently and in type at least half as large as thatused for any trade or brand name thereof,

b.         The formula showing quantitatively each ingredient of suchdrug to the extent required for labels under section 502(e) of the federal act,and

c.         Such other information in brief summary relating to sideeffects, contraindications, and effectiveness as shall be required inregulations issued under the federal act.

(17)      If a trademark, trade name or other identifying mark, imprintor device of another or any likeness of the foregoing has been placed thereonor upon its container with intent to defraud.

(18)      If it is a drug and its packaging or labeling is in violationof an applicable regulation issued pursuant to section 3 or 4 of the FederalPoison Prevention Packaging Act of 1970. (1939, c. 320, s. 15; 1949, c. 370; 1973, c. 831, s. 1; 1975, c. 614,ss. 25‑28, 30; 1997‑261, s. 33.)


State Codes and Statutes

State Codes and Statutes

Statutes > North-carolina > Chapter_106 > GS_106-134

§ 106‑134.  Drugsdeemed misbranded.

A drug or device shall be deemed to be misbranded:

(1)        If its labeling is false or misleading in any particular, orif its labeling or packaging fails to conform with the requirements of G.S. 106‑139or 106‑139.1 of this Article.

(2)        If in package form unless it bears a label containing

a.         The name and place of business of the manufacturer, packer,or distributor; and

b.         An accurate statement of the quantity of the contents interms of weight, measure, or numerical count, which statement shall beseparately and accurately stated in a uniform location upon the principaldisplay panel of the label, except as exempted with respect to this clause byG.S. 106‑121(2a)c of this Article; provided, that under paragraph b ofthis subdivision reasonable variations shall be permitted, and exemptions as tosmall packages shall be established, by regulations prescribed by the Board ofAgriculture.

(3)        If any word, statement, or other information required by orunder authority of this Article to appear on the label or labeling is notprominently placed thereon with such conspicuousness (as compared with otherwords, statements, designs or devices, in the labeling) and in such terms as torender it likely to be read and understood by the ordinary individual undercustomary conditions of purchase and use.

(4)        If it is for use by man and contains any quantity of thenarcotic or hypnotic substance alphaeucaine, barbituric acid, betaeucaine,bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin,marijuana, morphine, opium, paraldehyde, peyote, or sulphonmethane; or anychemical derivative of such substances, which derivative has been by the Boardafter investigation, found to be, and by regulations under this Article,designated as, habit forming; unless its label bears the name and quantity orproportion of such substance or derivative and in juxtaposition therewith thestatement "Warning – May be habit forming."

(5)        a.         If it is a drug, unless:

1.         Its label bears, to the exclusion of any othernonproprietary name (except the applicable systematic chemical name or thechemical formula),

I.          The established name (as defined in paragraph b of thissubdivision) of the drug, if such there be, and

II.         In case it is fabricated from two or more ingredients theestablished name and quantity of each active ingredient, including the kind andquantity or proportion of any alcohol and also including, whether active ornot, the established name and quantity or proportion of any bromides, ether, chloroform,acetanilid, acetphenetidin, amidopyrine, antipyrine, atropine, hyoscine,hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury, ouabain,strophanthin, strychnine, thyroid, or any derivative or preparation of any suchsubstances, contained therein: Provided, that the requirement for stating thequantity of the active ingredients, other than the quantity of thosespecifically named in this subdivision, shall apply only to prescription drugs;and

2.         For any prescription drug the established name of such drugor ingredient, as the case may be, on such label (and on any labeling on whicha name for such drug or ingredient is used) is printed prominently and in typeat least half as large as that used thereon for any proprietary name or designationfor such drug or ingredient; and provided, that to the extent that compliancewith the requirements of 1 II or 2 of this subdivision is impracticable,exemptions shall be allowed under regulations promulgated by the Board.

b.         As used in this subdivision (5), the term "establishedname," with respect to a drug or ingredient thereof, means:

1.         The applicable official name designated pursuant to section508 of the federal act, or

2.         If there is no such name and such drug, or such ingredient,is an article recognized in an official compendium, then the official titlethereof, in such compendium, or

3.         If neither 1 nor 2 of this paragraph applies, then thecommon or usual name, if any, of such drug or of such ingredient:

Provided further, that where 2 of this sub‑subdivisionapplies to an article recognized in the United States Pharmacopoeia and in theHomeopathic Pharmacopoeia under different official titles, the official titleused in the United States Pharmacopoeia shall apply unless it is labeled andoffered for sale as a homeopathic drug, in which case the official title usedin the Homeopathic Pharmacopoeia shall apply.

(6)        Unless its labeling bears

a.         Adequate directions for use; and

b.         Such adequate warnings against use in those pathologicalconditions or by children where its use may be dangerous to health, or againstunsafe dosage or methods or duration of administration or application, in suchmanner and form, as are necessary for the protection of users: Provided, thatwhere any requirement of paragraph a of this subdivision, as applied to anydrug or device, is not necessary for the protection of the public health, theBoard of Agriculture shall promulgate regulations exempting such drug or devicefrom such requirements.

(7)        If it purports to be a drug the name of which is recognizedin an official compendium, unless it is packaged and labeled as prescribedtherein: Provided, that the method of packing may be modified with the consentof the Board of Agriculture. Whenever a drug is recognized in both the UnitedStates Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States, itshall be subject to the requirements of the United States Pharmacopoeia withrespect to packaging and labeling unless it is labeled and offered for sale asa homeopathic drug, in which case it shall be subject to the provisions of theHomeopathic Pharmacopoeia of the United States and not to those of the UnitedStates Pharmacopoeia.

(8)        If it has been found by the Department of Agriculture andConsumer Services to be a drug liable to deterioration, unless it is packagedin such form and manner, and its label bears a statement of such precautions,as the Board of Agriculture shall by regulations require as necessary for theprotection of public health. No such regulation shall be established for anydrug recognized in an official compendium until the Commissioner of Agricultureshall have informed the appropriate body charged with the revision of suchcompendium of the need for such packaging or labeling requirements and suchbody shall have failed within a reasonable time to prescribe such requirements.

(9)        a.         If it is a drug and itscontainer is so made, formed, or filled as to be misleading; or

b.         If it is an imitation of another drug; or

c.         If it is offered for sale under the name of another drug.

(10)      If it is dangerous to health when used in the dosage, or withthe frequency or duration prescribed, recommended, or suggested in the labelingthereof.

(11),     (12) Repealed by Session Laws 1975, c. 614, s. 28.

(13)      If it is, or purports to be, or is represented as a drugcomposed wholly or partly of insulin, unless:

a.         It is from a batch with respect to which a certificate orrelease has been issued pursuant to section 506 of the federal act, and

b.         Such certificate or release is in effect with respect tosuch drug.

(14)      If it is, or purports to be, or is represented as a drugcomposed wholly or partly of any kind of penicillin, streptomycin,chlortetracycline, chloramphenicol, bacitracin, or any other antibiotic drug,or any derivative thereof, unless

a.         It is from a batch with respect to which a certificate orrelease has been issued pursuant to section 507 of the federal act, and

b.         Such certificate or release is in effect with respect tosuch drug:

Provided, that this subsection shall not apply to anydrug or class of drugs exempted by regulations promulgated under section 507(c)or (d) of the federal act. For the purpose of this subsection the term"antibiotic drug" means any drug intended for use by man containingany quantity of any chemical substance which is produced by microorganisms andwhich has the capacity to inhibit or destroy microorganisms in dilute solution(including the chemically synthesized equivalent of any such substance).

(15)      If it is a color additive, the intended use of which in or ondrugs is for the purpose of coloring only, unless its packaging and labelingare in conformity with such packaging and labeling requirements applicable tosuch color additive, prescribed under the provisions of G.S. 106‑132 ofthis Article.

(16)      In the case of any prescription drug distributed or offeredfor sale in this State, unless the manufacturer, packer, or distributor thereofincludes in all advertisements and other descriptive printed matter issued orcaused to be issued by the manufacturer, packer, or distributor with respect tothat drug a true statement of

a.         The established name, as defined in G.S. 106‑134(5)bof this Article, printed prominently and in type at least half as large as thatused for any trade or brand name thereof,

b.         The formula showing quantitatively each ingredient of suchdrug to the extent required for labels under section 502(e) of the federal act,and

c.         Such other information in brief summary relating to sideeffects, contraindications, and effectiveness as shall be required inregulations issued under the federal act.

(17)      If a trademark, trade name or other identifying mark, imprintor device of another or any likeness of the foregoing has been placed thereonor upon its container with intent to defraud.

(18)      If it is a drug and its packaging or labeling is in violationof an applicable regulation issued pursuant to section 3 or 4 of the FederalPoison Prevention Packaging Act of 1970. (1939, c. 320, s. 15; 1949, c. 370; 1973, c. 831, s. 1; 1975, c. 614,ss. 25‑28, 30; 1997‑261, s. 33.)