NORTH CAROLINA GENERAL ASSEMBLY
1975 SESSION

CHAPTER 614
HOUSE BILL 972

AN ACT TO AMEND ARTICLE 12 OF CHAPTER 106 OF THE GENERAL STATUTES, THE NORTH CAROLINA FOOD, DRUG AND COSMETIC ACT.

The General Assembly of North Carolina enacts:

Section 1.  G.S. 106-121(12) is amended as follows:
(a)	by inserting in line 3 of subdivision (a) the words "and effectiveness" after the word "safety".
(b)	by inserting in line 3 of subdivision (a) the words "and effective" after the word "safe".
(c)	by inserting in line 2 of subdivision (b) the words "and effectiveness" after the word "safety".
Sec. 2.  G.S. 106-121 is further amended by adding at the end thereof the following:
"(18)	The term 'counterfeit drug' means a drug which, or the container or labeling of which, without authorization, bears the trademark, trade name or other identifying mark, imprint, or device, or any likeness thereof, of a drug manufacturer, processor, packer or distributor other than the person or persons who in fact manufactured, processed, packed or distributed such drug and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other drug manufacturer, processor, packer or distributor.
(19)	The term 'consumer commodity' except as otherwise specifically provided by this subsection, means any food, drug, device, or cosmetic as those terms are defined by this act. Such term does not include:
(a)	any tobacco or tobacco product; or
(b)	any commodity subject to packaging or labeling requirements imposed under the North Carolina Pesticide Law of 1971, Article 52, Chapter 143, of the General Statutes of North Carolina, or the provisions of the eighth paragraph under the heading 'Bureau of Animal Industry' of the act of March 4, 1913 (37 Stat. 832-833; 21 U.S.C. 151-157) commonly known as the Virus-Serum Toxin Act; or
(c)	any drug subject to the provisions of G.S. 106-134(11) or G.S. 106‑134.1 of this act, or Section 503(b)(1) or 506 of the Federal Act; or
(d)	any beverage subject to or complying with packaging or labeling requirements imposed under the Federal Alcohol Administration Act (27 U.S.C., et seq.); or
(e)	any commodity subject to the provisions of the North Carolina Seed Law, Article 31, Chapter 106 of the General Statutes of North Carolina.
(20)	The term 'principal display panel' means that part of a label that is most likely to be displayed, presented, shown, or examined under normal and customary conditions of display for retail sale.
(21)	The term 'package' means any container or wrapping in which any consumer commodity is enclosed for use in the delivery or display of that consumer commodity to retail purchasers, but does not include:
(a)	shipping containers or wrappings used solely for the transportation of any consumer commodity in bulk or in quantity to manufacturers, packers, or processors, or to wholesale or retail distributors thereof; or
(b)	shipping containers or outer wrappings used by retailers to ship or deliver any commodity to retail customers if such containers and wrappings bear no printed matter pertaining to any particular commodity.
(22)	The term 'pesticide chemical' means any substance which, alone, in chemical combination, or in formulation with one or more other substances is a 'pesticide' within the meaning of the North Carolina Pesticide Law of 1971, Article 52, Chapter 143, of the General Statutes of North Carolina, or the Federal Insecticide, Fungicide and Rodenticide Act (7 U.S.C. 135 et seq.), and which is used in the production, storage, or transportation of raw agricultural commodities.
(23)	The term 'raw agricultural commodity' means any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing.
(24)	The term 'food additive' means any substance, the intended use of which results or may be reasonably expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food(including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting or holding food; and including any source of radiation intended for any such use) if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in a food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use; except that such term does not include:
(a)	a pesticide chemical in or on a raw agricultural commodity; or
(b)	a pesticide chemical to the extent that it is intended for use or is used in the production, storage, or transportation of any raw agricultural commodity; or
(c)	a color additive; or
(d)	any substance used in accordance with a sanction or approval granted prior to the enactment of the Food Additives Amendment of 1958, pursuant to the Federal Act; the Poultry Products Inspection Act (21 U.S.C. 451 et seq.) or the Meat Inspection Act of March 4, 1907 (34 Stat. 1260), as amended and extended (21 U.S.C. 71 et seq.).
(25)	The term ' color additive' means a material which:
(a)	is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity, from a vegetable, animal, mineral, or other source; or
(b)	when added or applied to a food, drug, or cosmetic, or to the human body or any part thereof, is capable (alone or through reaction with other substance) of imparting color thereto; Provided, that such term does not apply to any pesticide chemical, soil or plant nutrient, or other agricultural chemical solely because of its effect in aiding, retarding, or otherwise affecting, directly or indirectly, the growth or other natural physiological process of produce of the soil and thereby affecting its color, whether before or after harvest.
(26)	The term 'color' includes black, white, and intermediate grays.
(27)	The term 'practitioner' means a physician, dentist, veterinarian or other person licensed, registered or otherwise permitted to distribute, dispense, conduct research with respect to or to administer a drug so long as such activity is within the normal course of professional practice or research."
Sec. 3.  G.S. 106-122 is amended by adding at the end thereof the following:
"(12)	The sale at retail of any food for which a definition and standard of identity for enrichment with vitamins, minerals or other nutrients has been promulgated by the board, unless such food conforms to such definition and standard, or has been specifically exempted from same by the board.
(13)	The distribution in commerce of a consumer commodity, as defined in this Article, if such commodity is contained in a package, or if there is affixed to that commodity a label, which does not conform to the provisions of this Article and regulations promulgated under authority of this Article; Provided, however, that this prohibition shall not apply to persons engaged in business as wholesale or retail distributors of consumer commodities except to the extent that such persons:
(a)	are engaged in the packaging or labeling of such commodities; or
(b)	prescribe or specify by any means the manner in which such commodities are packaged or labeled.
(14)	The using by any person to his own advantage, or revealing, other than to the Commissioner or authorized officers or employees of the department, or to the courts when relevant in any judicial proceeding under this Article, any information acquired under authority of this Article concerning any method or process which as a trade secret is entitled to protection.
(15)	In the case of a prescription drug distributed or offered for sale in this State, the failure of the manufacturer, packer, or distributor thereof to maintain for transmittal, or to transmit, to any practitioner licensed by applicable law to administer such drug within the normal course of professional practice, who makes written request for information as to such drug, true and correct copies of all printed matter which is required to be included in any package in which that drug is distributed or sold, or such other printed matter as is approved under the Federal Act. Nothing in this paragraph shall be construed to exempt any person from any labeling requirement imposed by or under other provisions of this Article.
(16)	(a)	Placing or causing to be placed upon any drug or device or container thereof, with intent to defraud, the trade name or other identifying mark, or imprint of another or any likeness of any of the foregoing; or
(b)	Selling, dispensing, disposing of or causing to be sold, dispensed or disposed of, or concealing or keeping in possession, control or custody, with intent to sell, dispense or dispose of, any drug, device or any container thereof, with knowledge that the trade name or other identifying mark or imprint of another or any likeness of any of the foregoing has been placed thereon in a manner prohibited by subsection (a) of this section; or
(c)	Making, selling, or disposing of; causing to be made, sold or disposed of; keeping in possession, control or custody; or concealing any punch, die, plate, stone, or other thing designed to print, imprint, or reproduce the trademark, trade name, or other identifying mark, imprint, or device of another or any likeness of any of the foregoing upon any drug or container or labeling thereof so as to render such drug a counterfeit drug.
(17)	The doing of any act which causes a drug to be a counterfeit drug, or the sale or dispensing, or the holding for sale or dispensing of a counterfeit drug.
(18)	Dispensing or causing to be dispensed a different drug in place of the drug ordered or prescribed without the express permission of the person ordering or prescribing.
(19)	The acquiring or obtaining or attempting to acquire or obtain any drug subject to the provisions of G.S. 106-134.1 (l)(c) or (d) by fraud, deceit, misrepresentation, or subterfuge, or by forgery or alteration of a prescription, or by the use of a false name, or the giving of a false address."
Sec. 4.  G.S. 106-122(6) which presently reads "(6) The refusal to permit entry or inspection, or refusal to permit the taking of a sample, as authorized by G.S. 106-140." is rewritten to read as follows:
"(6)	The refusal to permit entry or inspection, or to permit the taking of a sample, or to permit access to or copying of any record as authorized by G.S. 106‑140."
Sec. 5.  G.S. 106-122(9) is amended by adding the words "or adulterated" at the end thereof.
Sec. 6.  G.S. 106-124(a) which presently reads "(a) Any person who violates any of the provisions of G.S. 106-122 shall be guilty of a misdemeanor and shall on conviction thereof be subject to imprisonment in the county jail for not more than six months or a fine of not more than two hundred dollars ($200.00), or both such imprisonment and fine; but if the violation is committed after a conviction of such person under this section has become final, such person shall be subject to imprisonment in the county jail for not more than 12 months, or a fine of not more than four hundred dollars ($400.00), or both such imprisonment and fine." is rewritten to read as follows:
"(a)	Any person, firm or corporation violating any provision of this law, or any regulation of the Board adopted pursuant to this law, shall be guilty of a misdemeanor, and for each violation shall be fined not less than one hundred dollars ($100.00) nor more than one thousand dollars ($1,000), or shall be imprisoned for not more than 60 days, or both. In addition, if any person continues to violate or further violates any provision of this law after written notice from the Commissioner, or his duly designated agent, the court may determine that each day during which the violation continued or is repeated constitutes a separate violation subject to the foregoing penalties."
Sec. 7.  G.S. 106-125(a) is amended as follows:
(a)	by deleting the word "or" immediately after the word "device" on line 3;
(b)	by inserting a comma after the word "device" on line 3;
(c)	by adding the words "or consumer commodity" after the word "cosmetics" on line 3.
Sec. 8.  G.S. 106-125(a) is further amended by inserting the clause "or is in violation of G.S. 106-131 or G.S. 106-135 of this Article," after the word "Article" on line 4.
Sec. 9.  G.S. 106-125(b) is amended by inserting the clause "or to be in violation of G.S. 106-131 or G.S. 106-135 of this Article," after the word "misbranded" on line 2.
Sec. 10.  G.S. 106-126 is rewritten to read as follows:
"It shall be the duty of the solicitors and district attorneys of this State to promptly prosecute all violations of this Article."
Sec. 11.  G.S. 106-128 is amended by deleting the words "Secretary of the United States Department of Agriculture" in line 11 and inserting in lieu thereof the words "Commissioner of the Federal Food and Drug Administration".
Sec. 12.  G.S. 106-128 is amended by adding a paragraph at the end thereof as follows:
"Temporary permits now or hereafter granted for interstate shipment of experimental packs of food varying from the requirements of federal definitions and standards of identity are automatically effective in this State under the conditions provided in such permits. In addition, the Board of Agriculture may cause to be issued additional permits where they are necessary to the completion or conclusiveness of an otherwise adequate investigation and where the interests of consumers are safeguarded. Such permits are subject to the terms and conditions the Board of Agriculture may prescribe by regulation."
Sec. 13.  G.S. 106-129(1)(b) which presently reads "b. If it bears or contains any added poisonous or added deleterious substance which is unsafe within the meaning of G.S. 106-132; or" is rewritten to read as follows:
"b.	1.	If it bears or contains any added poisonous or added deleterious substance, other than one which is I. a pesticide chemical in or on a raw agricultural commodity; II. a food additive; or III. a color additive, which is unsafe within the meaning of G.S. 106-132; or 2. if it is a raw agricultural commodity and it bears or contains a pesticide chemical which is unsafe within the meaning of G.S. 106-132; or 3. if it is or it bears or contains any food additive which is unsafe within the meaning of G.S. 106-132; provided, that where a pesticide chemical has been used in or on a raw agricultural commodity in conformity with an exemption granted or tolerance prescribed under G.S. 106-132 of this Article, and such raw agricultural commodity has been subjected to processing such as canning, cooking, freezing, dehydrating, or milling, the residue of such pesticide chemical remaining in or on such processed food shall, notwithstanding the provisions of G.S. 106-132 and clause 3. of this section, not be deemed unsafe if such residue in or on the raw agricultural commodity has been removed to the extent possible in good manufacturing practice, and the concentration of such residue in the processed food when ready-to-eat, is not greater than the tolerance prescribed for the raw agricultural commodity; or".
Sec. 14.  G.S. 106-129(1) is further amended to add the following subsection:
"g.	If it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to G.S. 106-132 of this Article."
Sec. 15.  G.S. 106-129(3) which presently reads "(3) If it is confectionery and it bears or contains any alcohol or nonnutritive article or substance except harmless coloring, harmless flavoring, harmless resinous glaze not in excess of four-tenths of one per centum, harmless natural gum, and pectin; provided, that this subdivision shall not apply to any confectionery by reason of its containing less than one half of one per centum by volume of alcohol derived solely from the use of flavoring extracts, or to any chewing gum by reason of its containing harmless nonnutritive masticatory substances" is rewritten to read as follows:
"(3)	If it is confectionery, and:
(a)	has partially or completely imbedded therein any nonnutritive object: Provided, that this clause shall not apply in the case of any nonnutritive object if, in the judgment of the Board of Agriculture as provided by regulations, such object is of practical functional value to the confectionery product and would not render the product injurious or hazardous to health; or
(b)	bears or contains any alcohol other than alcohol not in excess of one-half of one per centum (1/2 of 1%) by volume derived solely from the use of flavoring extracts; or
(c)	bears or contains any nonnutritive substance: Provided, that this clause shall not apply to a safe nonnutritive substance which is in or on confectionery by reason of its use for some practical functional purpose in the manufacture, packaging, or storing of such confectionery if the use of the substance does not promote deception of the consumer or otherwise result in adulteration or misbranding in violation of any provision of this act: and provided further, that the Board may, for the purpose of avoiding or resolving uncertainty as to the application of this clause, issue regulations allowing or prohibiting the use of particular nonnutritive substances."
Sec. 16.  G.S. 106-129(4) which presently reads "(4) If it bears or contains a coal-tar color other than one from a batch which has been certified by the United States Department of Agriculture." is rewritten to read as follows:
"(4)	If it is or bears or contains any color additive which is unsafe within the meaning of G.S. 106-132."
Sec. 17.  G.S. 106-130(1) which presently reads "(1) If its labeling is false or misleading in any particular." is rewritten to read as follows:
"(1)	(a)	If its labeling is false or misleading in any particular, or
(b)	If its labeling or packaging fails to conform with the requirements of G.S. 106-139 and G.S. 106-139.1 of this Article."
Sec. 18.  G.S. 106-130(5)(b) is amended by striking the colon after the word "count" at the end of line 2, inserting a comma (,) in lieu thereof and the clause "which statement shall be separately and accurately stated in a uniform location upon the principal display panel of the label:".
Sec. 19.  G.S. 106-130(11), which presently reads "(11) If it bears or contains any artificial flavoring, artificial coloring, or chemical preservative, unless it bears a label stating that fact: Provided, that to the extent that compliance with the requirements of this subdivision is impracticable, exemptions shall be established by regulations promulgated by the Board of Agriculture: Provided further, that for the purpose of complying with the provisions of this Article, as it pertains to bottled soft drinks, either the bottle crown or the crown together with the blown-in-the-bottle or annealed-to-the- bottle statements, now in usual and common use in this State, shall be deemed sufficient labeling and no paper label shall be necessary." is rewritten in its entirety to read:
"(11)	If it bears or contains any artificial flavoring, artificial coloring, or chemical preservatives, unless it bears labeling stating that fact: Provided, that to the extent that compliance with the requirements of this subdivision are impracticable, exemptions shall be established by regulations promulgated by the Board of Agriculture. The provisions of this subdivision and subdivisions (7) and (9) with respect to artificial coloring do not apply to butter, cheese, or ice cream. The provisions of this subdivision with respect to chemical preservatives do not apply to a pesticide chemical when used in or on a raw agricultural commodity which is the product of the soil."
Sec. 20.  G.S. 106-130 is amended by adding three new subsections as follows:
"(12)	If it is a raw agricultural commodity which is the produce of the soil, bearing or containing a pesticide chemical applied after harvest, unless the shipping container of such commodity bears labeling which declares the presence of such chemical in or on such commodity and the common or usual name and the function of such chemical: Provided, however, that no such declaration shall be required while such commodity, having been removed from the shipping container, is being held or displayed for sale at retail out of such container in accordance with the custom of the trade.
(13)	If it is a product intended as an ingredient of another food and when used according to the directions of the purveyor will result in the final food product being adulterated or misbranded.
(14)	If it is a color additive unless its packaging and labeling are in conformity with such packaging and labeling requirements applicable to such color additive prescribed under the provisions of G.S. 106-132 of this Article."
Sec. 21.  G.S. 106-132, which presently reads:
"§ 106-132.  Regulations by Board of Agriculture as to use of deleterious substances. — Any poisonous or deleterious substance added to any food, except where such substance is required in the production thereof or cannot be avoided by good manufacturing practice, shall be deemed to be unsafe for the purpose of the application of paragraph b. of subdivision (1) of G.S. 106-129; but when such substance is so required or cannot be so avoided, the Board of Agriculture shall promulgate regulations limiting the quantity therein or thereon to such extent as the Board finds necessary for the protection of public health, and any quantity exceeding the limits so fixed shall also be deemed to be unsafe for the purposes of the application of paragraph b. of subdivision (1) of G.S. 106-129. While such a regulation is in effect limiting the quantity of any such substance in the case of any food, such food shall not, by reason of bearing or containing any added amount of such substance, be considered to be adulterated within the meaning of paragraph b., subdivision (1), G.S. 106-129. In determining the quantity of such added substance to be tolerated in or on different articles of food, the Board shall take into account the extent to which the use of such substance is required or cannot be avoided in the production of each such article, and the other ways in which the consumer may be affected by the same or other poisonous or deleterious substances."
is hereby rewritten in its entirety to read as follows:
"§ 106-132.  Any added poisonous or added deleterious substance, any food additive, any pesticide chemical in or on a raw agricultural commodity or any color additive, shall with respect to any particular use or intended use be deemed unsafe for the purpose of application of G.S. 106-129(1), sub- subdivisions b. and g. and G.S. 106-129(4) with respect to any food, G.S. 106-133(1) with respect to any drug or device, or G.S. 106-136(1) and (5) with respect to any cosmetic, unless there is in effect a regulation pursuant to G.S. 106-139 of this Article limiting the quantity of substance, and the use or intended use of such substance conforms to the terms prescribed by such regulation. While such regulations relating to such substance are in effect, a food, drug, or cosmetic shall not, by reason of bearing or containing such substance in accordance with the regulations be considered adulterated within the meaning of G.S. 106-129(1)(a), G.S. 106-133(1) and G.S. 106-136(1)."
Sec. 22.  G.S. 106-133(1)(d) which presently reads "(d) If it is a drug and it bears or contains, for purposes of coloring only, a coal-tar color other than one from a batch certified by the United States Department of Agriculture." is rewritten in its entirety to read:
"(d)	If 1. it is a drug and it bears or contains, for purposes of coloring only, a color additive which is unsafe within the meaning of G.S. 106-132, or 2. if it is a color additive, the intended use of which in or on drugs is for purposes of coloring only, and is unsafe within the meaning of G.S. 106-132."
Sec. 23.  G.S. 106-133(1) is amended by adding at the end thereof:
"(e)	If it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this Article as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess."
Sec. 24.  G.S. 106-133(2) is amended to strike the words "by the United States Department of Agriculture" in lines 7 and 8 thereof and by inserting in lieu thereof the words "under authority of the Federal Act."
Sec. 25.  G.S. 106-134(1) is amended by putting a comma after the word "particular" and by adding immediately after the comma "or if its labeling or packaging fails to conform with the requirements of G.S. 106-139 or G.S. 106-139.1 of this Article."
Sec. 26.  G.S. 106-134(2)(b) is amended by striking the colon following the word "count" in line 2 and putting a comma in lieu thereof and by inserting immediately after the comma the following:
"which statement shall be separately and accurately stated in a uniform location upon the principal display panel of the label, except as exempted with respect to this clause by G.S. 106‑121(19)(c) of this Article;".
Sec. 27.  G.S. 106-134(5) which reads "(5) If it is a drug and is not designated solely by a name recognized in an official compendium unless its label bears (a) The common or usual name of the drug, if such there be; and (b) In case it is fabricated from two or more ingredients, the common or usual name of each active ingredient, including the kind and quantity or proportion of any alcohol, and also including, whether active or not, the 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 such substances, contained therein: Provided, that to the extent that compliance with the requirements of paragraph (b) of this subdivision is impracticable, exemptions shall be established by regulations promulgated by the Board of Agriculture." is rewritten in its entirety to read as follows: 
"(5)	a.	If it is a drug, unless: 1. its label bears, to the exclusion of any other non-proprietary name (except the applicable systematic chemical name or the chemical formula), I. the established name (as defined in sub-subdivision b. of this subdivision) of the drug, if such there be, and II. in case 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, acetanilid, acetphenetidin, amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or any derivative or preparation of any such substances, contained therein: Provided, that the requirement for stating the quantity of the active ingredients, other than the quantity of those specifically named in this subdivision, shall apply only to prescription drugs; and 2. for any prescription drug the established name of such drug or ingredient, as the case may be, on such label (and on any labeling on which a name for such drug or ingredient is used) is printed prominently and in type at least half as large as that used thereon for any proprietary name or designation for such drug or ingredient; and provided, that to the extent that compliance with 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 'established name', with respect to a drug or ingredient thereof, means: 1. the applicable official name designated pursuant to Section 508 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 title thereof, in such compendium, or 3. if neither 1. nor 2. of this sub-subdivision applies, then the common or usual name, if any, of such drug or of such ingredient: Provided further, that where 2. of this sub- subdivision applies to an article recognized in the United States Pharmacopoeia and in the Homeopathic Pharmacopoeia under different official titles, the official title used in the United States Pharmacopoeia shall apply unless it is labeled and offered for sale as a homeopathic drug, in which case the official title used in the Homeopathic Pharmacopoeia shall apply."
Sec. 28.  G.S. 1 06- 1 34(11) and (12) are hereby repealed.
Sec. 29.  Article 12 of Chapter 106 is further amended by inserting between G.S. 106-134 and G.S. 106-135 the following:
"§ 106-134.1.  (1) A drug intended for use by man which:
a.	is a habit-forming drug to which G.S. 106-134(4) applies; or
b.	because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug in the course of his normal practice; or
c.	is limited by an approved application under Section 505 of the Federal Act to use under the professional supervision of a practitioner licensed by law to administer such drug; or
d.	is a drug the label of which bears the statement 'Caution: Federal law prohibits dispensing without a prescription', shall be dispensed only 1. upon a written prescription of a practitioner licensed by law to administer such drug, or 2. upon an oral prescription of such practitioner which is reduced promptly to writing and filed by the pharmacist, or 3. by refilling any such written or oral prescription if such refilling is authorized by the prescriber either in the original prescription or by oral order which is reduced promptly to writing and filed by the pharmacist. If any prescription for such drug does not indicate the times it may be refilled, if any, such prescription may not be refilled unless the pharmacist is subsequently authorized to do so by the practitioner. The act of dispensing a drug contrary to the provisions of this paragraph shall be deemed to be an act which results in a drug being misbranded while held for sale.
(2)	Any drug dispensed by filling or refilling a written or oral prescription of a practitioner licensed by law to administer such drug shall be exempt from the requirements of G.S. 106-134, except subsections (1), (9)(b) and (c), (11) and(12), and the packaging requirements of subsections (7) and (8), if the drug bears an affixed label containing the name of the patient, the name and address of the pharmacy, the phrase 'Filled by ' or 'Dispensed by ', with the name of the practitioner who dispenses the prescription appearing in the blank, the serial number and date of the prescription or of its filling, the name of the prescriber, the directions for use, and unless otherwise directed by the prescriber of such drug, the name and strength of such drug. This exemption shall not apply to any drugs dispensed in the course of the conduct of a business of dispensing drugs pursuant to diagnosis by mail, or to a drug dispensed in violation of subsection (1) of this section.
(3)	The Board may, by regulation, remove drugs subject to G.S. 106-134(4) and G.S. 106-135 from the requirements of subsection (1) of this section when such requirements are not necessary for the protection of the public health. Drugs removed from the prescription requirements of the federal act by regulations issued thereunder shall also, by regulations issued by the board, be removed from the requirement of subsection (1).
(4)	A drug which is subject to subsection (1) of this section shall be deemed to be misbranded if at any time prior to dispensing its label fails to bear the statement 'Caution: Federal Law Prohibits Dispensing Without Prescription'. A drug to which subsection (1) of this section does not apply shall be deemed to be misbranded if at any time prior to dispensing its label bears the caution statement quoted in the preceding sentence.
(5)	Nothing in this section shall be construed to relieve any person from any requirement prescribed by or under authority of law with respect to drugs now included or which may hereafter be included within the classification of 'controlled substances' as this term is defined in applicable Federal and State Controlled Substance Acts."
Sec. 30.  G.S. 106-134 is amended by adding the following new subsections:
"(11)	If it is, or purports to be, or is represented as a drug composed wholly or partly of insulin, unless: a. it is from a batch with respect to which a certificate or release has been issued pursuant to Section 506 of the Federal Act, and b. such certificate or release is in effect with respect to such drug.
(12)	If it is, or purports to be, or is represented as a drug composed 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 or release has been issued pursuant to Section 507 of the Federal Act, and b. such certificate or release is in effect with respect to such drug: Provided, that this subsection shall not apply to any drug 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 containing any quantity of any chemical substance which is produced by microorganisms and which has the capacity to inhibit or destroy microorganisms in dilute solution (including the chemically synthesized equivalent of any such substance).
(13)	If it is a color additive, the intended use of which in or on drugs is for the purpose of coloring only, unless its packaging and labeling are in conformity with such packaging and labeling requirements applicable to such color additive, prescribed under the provisions of G.S. 106-132 of this Article.
(14)	In the case of any prescription drug distributed or offered for sale in this State, unless the manufacturer, packer, or distributor thereof includes in all advertisements and other descriptive printed matter issued or caused to be issued by the manufacturer, packer, or distributor with respect to that drug a true statement of a. the established name, as defined in G.S. 106-134(5)(b) of this Article, printed prominently and in type at least half as large as that used for any trade or brand name thereof, b. the formula showing quantitatively each ingredient of such drug to the extent required for labels under Section 502(e) of the Federal Act, and c. such other information in brief summary relating to side effects, contraindications, and effectiveness as shall be required in regulations issued under the Federal Act.
(15)	If a trademark, trade name or other identifying mark, imprint or device of another or any likeness of the foregoing has been placed thereon or upon its container with intent to defraud.
(16)	If it is a drug and its packaging or labeling is in violation of an applicable regulation issued pursuant to Section 3 or 4 of the Federal Poison Prevention Packaging Act of 1970."
Sec. 31.  G.S. 106-135 is rewritten in its entirety to read as follows:
"§ 106-135.  (a) No person shall sell, deliver, offer for sale, hold for sale or give away any new drug unless:
(1)	An application with respect thereto has been approved and said approval has not been withdrawn under Section 505 of the Federal Act, or
(2)	When not subject to the Federal Act, by virtue of not being a drug in interstate commerce, unless such drug has been tested and has been found to be safe for use and effective in use under the conditions prescribed, recommended, or suggested in the labeling thereof, and prior to selling or offering for sale such drug, there has been filed with the Commissioner an application setting forth
a.	Full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use;
b.	A full list of the articles used as components of such drug;
c.	A full statement of the composition of such drug;
d.	A full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug;
e.	Such samples of such drug and of the articles used as components thereof as the Commissioner may require; and
f.	Specimens of the labeling proposed to be used for such drug.
(b)	An application provided for in subdivision (a)(2) of this section shall become effective on the 180th day after the filing thereof, except that if the Commissioner finds, after due notice to the applicant and giving him an opportunity for hearing,
(1)	That the drug is not safe or not effective for use under the conditions prescribed, recommended or suggested in the proposed labeling thereof; or
(2)	The methods used in, and the facilities and controls used for, the manufacture, processing and packing of such drug is inadequate to preserve its identity, strength, quality, and purity; or
(3)	Based on a fair evaluation of all material facts, such labeling is false or misleading in any particular; he shall, prior to the effective date of the application, issue an order refusing to permit the application to become effective.
(c)	An order refusing to permit an application under this section to become effective may be revoked by the Commissioner.
(d)	The Commissioner shall promulgate regulations for exempting from the operation of the foregoing subsections and subdivisions of this section drugs intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs. Such regulations may, within the discretion of the Commissioner among other conditions relating to the protection of the public health, provide for conditioning such exemption upon
(1)	The submission to the Commissioner, before any clinical testing of a new drug is undertaken, of reports, by the manufacturer or the sponsor of the investigation of such drug, of preclinical tests (including tests on animals) of such drug adequate to justify the proposed clinical testing;
(2)	The manufacturer or the sponsor of the investigation of a new drug proposed to be distributed to investigators for clinical testing obtaining a signed agreement from each of such investigators that patients to whom the drug is administered will be under his personal supervision, or under the supervision of investigators responsible to him, and that he will not supply such drug to any other investigator, or to clinics, for administration to human beings; and
(3)	The establishment and maintenance of such records, and the making of such reports to the Commissioner, by the manufacturer or the sponsor of the investigation of such drug, of data (including but not limited to analytical reports by investigators) obtained as the result of such investigational use of such drug, as the Commissioner finds will enable him to evaluate the safety and effectiveness of such drug in the event of the filing of an application pursuant to subsection (b).
Such regulations shall provide that such exemption shall be conditioned upon the manufacturer, or the sponsor of the investigation, requiring that experts using such drugs for investigational purposes certify to such manufacturer or sponsor that they will inform any human beings to whom such drugs, or any controls used in connection therewith, are being administered, or their representatives, that such drugs are being used for investigational purposes and will obtain the consent of such human beings or their representatives, except where they deem it not feasible, or, in their professional judgment, contrary to the best interests of such human beings. Nothing in this subsection shall be construed to require any clinical investigator to submit directly to the Commissioner reports on the investigational use of drugs; provided, that regulations adopted under Section 505(i) of the Federal Act may be adopted by the Commissioner as the regulations in this State.
(e)	(1)	In the case of any drug for which an approval of an application filed pursuant to this section is in effect, the applicant shall establish and S such records, and make such reports to the Commoner, of data relating to clinical experience and other data or information, received or otherwise obtained by such applicant with respect to such drug, as the Commissioner may by general regulation, or by order with respect to such application, prescribe: Provided, however, that regulations and orders So under h s subsection and under subsection (d) shall have due regard or the professional ethics of the medical profession and the interests of patients and shall provide, where the Commissioner deems it to be appropriate, for the examination, upon request, by the persons to whom such regulations or orders are applicable, of similar information received or otherwise obtained by the Commissioner.
(2)	Every person required under this section to maintain records and every person in charge or custody thereof, shall, upon request of an officer or employee designated by the Commissioner, permit such officer or employee at all reasonable times to have access to and copy and certify such records.
(f)	The Commissioner may, after affording an opportunity for public hearing, revoke an application approved pursuant to this section if he finds that the drug, based on evidence acquired after such approval, may not be safe or effective for its intended use, or that the facilities or controls used in the manufacture, processing, or labeling of such drug may present a hazard to the public health.
(g)	This section shall not apply:
(1)	To a drug sold in this State or introduced into interstate commerce at any time prior to the enactment of the Federal Act, if its labeling contained the same representations concerning the conditions of its use; or
(2)	To any drug which is licensed under the Public Health Service Act of July 1 1944 (58 stat. 682, as amended; 42 U.S.C. 201 et seq.) or under the Animal Virus-Serum-Toxin Act of March 4, 1913 (13 stat. 832; 21 U.S.C. 151 et seq.); or
(3)	To any drug which is subject to Section 106-134(12) of this Article."
Sec 32.  G.S. 106-136(5) which presently reads:
"(5)	If it is not a hair dye and it bears or contains a coal-tar color other than one from a batch which has been certified by the United States Department of Agriculture." is rewritten in its entirety to read as follows:
"(5)	If it is not a hair dye and it is, or it bears or contains a color additive which is unsafe within the meaning of G.S. 106-132."
Sec. 33.  G.S. 106-137(1) which presently reads:
"(1)	If its labeling is false or misleading in any particular" is rewritten in its entirety to read as follows:
"(1)	(a)	If its labeling is false or misleading in any particular; or
(b)	If its labeling or packaging fails to conform with the requirements of Section 106-139 and 106-139.1 of this Article."
Sec 34.  G S 106-137(2)(b) is amended by deleting the colon after the word "count" on line 2 of subdivision (b), inserting in lieu thereof a comma and inserting immediately thereafter the clause "which statement shal1 be separately and accurately stated in a uniform location upon the principal display panel of the label:".
Sec. 35.  G.S. 106-137 is further amended by adding the following new subsection:
"(5)	If it is a color additive, unless its packaging and labeling are in conformity with such packaging and labeling requirements applicable to such color additive prescribed under the provisions of G.S. 106-132 of this Article. This subsection shall not apply to packages of color additives which, with respect to their use for cosmetics, are marketed and intended for use only in or on hair dyes (as defined in the last sentence of G.S. 106-136(1))."
Sec. 36.  G.S. 106-139 is rewritten in its entirety to read as follows:
"§ 106-139(a).  The authority to promulgate regulations for the efficient enforcement of this Article is hereby vested in the Board of Agriculture, except the Commissioner of Agriculture is hereby authorized to promulgate regulations under G.S. 106-131 and G.S. 106-135. The Board and Commissioner are hereby authorized to make the regulations promulgated under this Article conform, insofar as practicable, with those promulgated for foods, drugs, devices, cosmetics and consumer commodities under the Federal Act, including but not limited to pesticide chemical residues on or in foods, food additives, color additives, special dietary foods, labeling of margarine for retail sale or distribution, nutritional labeling of foods, the fair packaging and labeling of consumer commodities and new drug clearance. Notwithstanding the provisions of subsection (e) of this section, a Federal regulation adopted by the Board or Commissioner pursuant to this Article shall take effect in this State on the date it becomes effective as a Federal regulation.
(b)	The Board may promulgate regulations exempting from any affirmative labeling requirement of this Article consumer commodities which are, in accordance with the practice of the trade, to be processed, labeled or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such consumer commodities are not adulterated or misbranded under the provisions of this Article upon removal from such processing, labeling or repacking establishment. The Board may additionally promulgate regulations exempting from any labeling requirement of this Article foods packaged or dispensed at the direction of the retail purchaser at the time of sale, whether or not for immediate consumption by the purchaser on the premises of the seller.
(c)	Whenever the Board determines that regulations containing prohibitions or requirements other than those prescribed by G.S. 106-139.1(a) are necessary to prevent the deception of consumers or to facilitate value comparisons as to any consumer commodity, the Board shall promulgate with respect to that commodity regulations effective to:
(1)	establish and define standards for the characterization of the size of a package enclosing any consumer commodity, which may be used to supplement the label statement of net quantity of contents of packages containing such commodity, but this paragraph shall not be construed as authorizing any limitation of the size, shape, weight dimensions, or number of packages which may be used to enclose any commodity;
(2)	regulate the placement upon any package containing any commodity or upon any label affixed to such commodity, of any printed matter stating or representing by implication that such commodity is offered for retail sale at a price lower than the ordinary and customary retail sale price or that a retail sale price advantage is accorded to purchasers thereof by reason of the size of that package or the quantity of its contents;
(3)	require that the label on each package of a consumer commodity bear a. the common or usual name of such consumer commodity, if any, and b. in case such consumer commodity consists of two or more ingredients, the common or usual name of each such ingredient listed in order of decreasing predominance, but nothing in this paragraph shall be deemed to require that any trade secret be divulged; or
(4)	prevent the nonfunctional slack-fill of packages containing consumer commodities.
For the purposes of subdivision (4) of this subsection, a package shall be deemed to be nonfunctionally slack-filled if it is filled of substantially less than its capacity for reasons other than a. protection of the contents of such package, or b. the requirements of machines used for enclosing the contents in such package; provided, the Board may adopt any regulations promulgated pursuant to the Federal Fair Packaging and Labeling Act which shall have the force and effect of law in this State.
(d)	Hearings authorized or required by Sections 106-131 or 106-135 of this Article shall be conducted by the Commissioner of Agriculture or such officer, agent, or employee as the Commissioner may designate for the purpose.
(e)	Before promulgation of any regulation, the Commissioner of Agriculture shall give 30 days' notice of the proposal and of the time and place for a hearing. The regulation so promulgated shall become effective on a date fixed by the Board of Agriculture, or Commissioner, as the case may be, which date shall not be prior to 90 days after its promulgation (except such regulations as may be promulgated under G.S. 106-131, which regulations shall become effective on the date of promulgation, and Federal regulations adopted as regulations in this State as provided by subsection (a) of this section). Such regulation may be amended or repealed in the same manner as is provided for its adoption; except that in the case of a regulation amending or repealing any such regulation the Board or Commissioner, to such extent as it deems necessary in order to prevent undue hardship, may disregard the foregoing provisions regarding notice, hearing, or effective date."
Sec. 37.  Article 12 of Chapter 106 is further amended by inserting between G.S. 106-139 and G.S. 106-140 the following:
"§ 106-139.1.  (a) All labels of consumer commodities, as defined by this Article, shall conform with the requirements for the declaration of net quantity of contents of Section 4 of the Federal Fair Packaging and Labeling Act (15 U.S.C. 1451, et seq.) and the regulations promulgated pursuant thereto: Provided, that consumer commodities exempted from such requirements of Section 4 of the Federal Fair Packaging and Labeling Act shall also be exempt from this subsection.
(b)	The label of any package of a consumer commodity which bears a representation as to the number of servings of such commodity contained in such package shall bear a statement of the net quantity (in terms of weight, measure, or numerical count) of each such serving.
(c)	No person shall distribute or cause to be distributed in commerce any packaged consumer commodity if any qualifying words or phrases appear in conjunction with the separate statement of the net quantity of contents required by subsection (a) of this section, but nothing in this section shall prohibit supplemental statements, at other places on the package, describing in nondeceptive terms the net quantity of contents: Provided, that such supplemental statements of net quantity of contents shall not include any term qualifying a unit of weight, measure, or count that tends to exaggerate the amount of the commodity contained in the package."
Sec. 38.  G.S. 106-140 is rewritten in its entirety to read as follows:
"§ 106-140.  (a) For purposes of enforcement of this Article, the Commissioner or any of his authorized agents, are authorized upon presenting appropriate credentials and a written notice to the owner, operator or agent in charge,
(1)	to enter at reasonable times any factory, warehouse or establishment in which food, drugs, devices or cosmetics are manufactured, processed, or packed or held for introduction into commerce or after such introduction or to enter any vehicle being used to transport or hold such food, drugs, devices or cosmetics in commerce; and
(2)	to inspect at reasonable times and in a reasonable manner such factory, warehouse, establishment or vehicle and all pertinent equipment, finished and unfinished materials, containers and labeling therein, and to obtain samples necessary to the endorsement of this Article. In the case of any factory, warehouse, establishment, or consulting laboratory in which any food, drug, device or cosmetic is manufactured, processed, analyzed, packed or held, the inspection shall extend to all things therein (including records, files, papers, processes, controls and facilities) bearing on whether any food, drug, device or cosmetic which is adulterated or misbranded within the meaning of this Article or which may not be manufactured, introduced into commerce or sold or offered for sale by reason of any provision of this Article, has been or is being manufactured, processed, packed, transported or held in any such place or otherwise bearing on violation of this Act. No inspection authorized by the preceding sentence shall extend to a. financial data, b. sales data other than shipment data, c. personnel data (other than data as to qualifications of technical and professional personnel performing functions subject to this Article), d. pricing data, and e. research data (other than data relating to new drugs and antibiotic drugs, subject to reporting and inspection under lawful regulations issued pursuant to Section 505(i) or (j) or Section 507(d) or (g) of the Federal Act, and data, relating to other drugs, which in the case of a new drug would be subject to reporting or inspection under lawful regulations issued pursuant to Section 505(j) of the Federal Act). Such inspection shall be commenced and completed with reasonable promptness. The provisions of the second sentence of this subsection shall not apply to such classes of persons as the Board may by regulation exempt from the application of this section upon a finding that inspection as applied to such classes of persons in accordance with this section is not necessary for the protection of the public health.
(3)	to have access to and to copy all records of carriers in commerce showing the movement in commerce of any food, drug, device, or cosmetic, or the holding thereof during or after such movement, and the quantity, shipper and consignee thereof: Provided, that evidence obtained under this subsection shall not be used in a criminal prosecution of the person from whom obtained; and provided further, that carriers shall not be subject to the other provisions of this Article by reason of their receipt, carriage, holding, or delivery of food, drugs, devices or cosmetics in the usual course of business as carriers.
(b)	Upon completion of any such inspection of a factory, warehouse, consulting laboratory or other establishment and prior to leaving the premises, the authorized agent making the inspection shall give to the owner, operator, or agent- in-charge a report in writing setting forth any conditions or practices observed by him which in his judgment indicate that any food, drug, device or cosmetic in such establishment:
(1)	consists in whole or in part of any filthy, putrid, or decomposed substance; or
(2)	has been prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth or whereby it may have been rendered injurious to health.
(c)	If the authorized agent making any such inspection of a factory, warehouse or other establishment has obtained any salable product samples in the course of the inspection, upon completion of the inspection and prior to leaving the premises he shall offer reasonable payment for any such product samples.
(d)	It shall be the duty of the Commissioner of Agriculture to make or cause to be made examination of samples secured under the provisions of this section to determine whether or not any provision of this Article is being violated."
Sec. 39.  G.S. 106-141 is amended by striking subsection (a) which presently reads:
"(a)	In the appointment of any drug inspector in carrying out the provisions of this Article, the Commissioner of Agriculture shall confer with the North Carolina Board of Pharmacy."
Sec. 40.  G.S. 106-144 which presently reads:
"§ 106-144.  Meats and meat products subject to Federal Meat and Inspection Act approved March 4, 1907, as amended, are exempted from the provisions of this Article so long as such meats and meat products remain in possession of the processor."
is rewritten in its entirety to read as follows:
"§ 106-144.  Meats and meat products subject to the Federal Meat Inspection Act of March 4, 1907, (34 Stat. 1260), as amended and extended (21 U.S.C. 71 et seq.), and poultry and poultry products subject to the Federal Poultry Products Inspection Act (21 U.S.C. 451 et seq.) are exempted from the provisions of this Article so long as such meat, meat products, poultry, and poultry products remain in the possession of the processor."
Sec. 41.  If any provision of this Act is declared unconstitutional or the applicability thereof to any person or circumstance is held invalid, the constitutionality of the remainder of the Act and applicability thereof to other persons and circumstances shall not be affected thereby.
Sec. 42.  (a) All laws and clauses of laws in conflict with or inconsistent with the provisions of this Article are hereby repealed and the North Carolina Bakery Inspection Law, Article 22, Chapter 106; the North Carolina Bottling Plant Law, Article 16, Chapter 106; the North Carolina Artificially Bleached Flour Law, Article 21, Chapter 106; the North Carolina Flour, Bread and Corn Meal Enrichment Act, Article 21A, Chapter 106; and the Oleomargarine Laws, Articles 23 and 24, Chapter 106 of the General Statutes, are hereby specifically repealed.
(b)	Notwithstanding any other provisions of law, all existing rules and regulations concerning the sanitation, safety, inspection, analysis, composition, manufacture, packing, transportation, holding or offering for sale of any food, drug, device or cosmetic of the State of North Carolina Department of Agriculture, not inconsistent with the provisions of this Article shall continue in full force until repealed, amended or modified.
Sec. 43.  This act shall become effective July 1, 1975.
In the General Assembly read three times and ratified, this the 16th day of June, 1975.