Mass. Gen. Laws ch. 94, sec. 187 — MA Code / Part I / Title XV / Chapter 94 / Section 187
''Misbranding'' term defined when applied to drugs, foods, cosmetics and devices; when not to be deemed adulterated, etc.
Status: in_force

Section 187. The term ''misbranded'' as used in this chapter shall apply to each drug, or article of food, or article which enters into the composition of food, the package or label of which bears any statement, design or device regarding such article or the ingredients or substance contained therein, which is false or misleading in any particular, and also to any food or drug product which is falsely branded as to the state or country where it was manufactured or produced. For the purposes of said sections an article shall also be deemed to be misbranded:— In the case of a drug: First, if it is so designated by the United States Food and Drug Administration, or if it is an imitation of or offered for sale under the name of another article. The department of public health shall maintain lists of drugs so designated as misbranded which shall be made available to physicians and pharmacists. Second, if the contents of the package as originally put up have been removed, in whole or in part, and other contents placed therein. Third, if its package or wrapper bears or contains any false or misleading statement, design, or device regarding the curative or therapeutic effect of such article or of any of the ingredients or substances contained therein. Fourth, if in package form it fails to bear a label containing the name and place of business of the manufacturer, packer or distributor. Fifth, if it is for use by man and contains any quantity of the narcotic or hypnotic substance alpha-eucaine, barbituric acid, beta-eucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marihuana, morphine, opium, paraldehyde, peyote or sulphonmethane; or any chemical derivative of any such substance, unless its label bears the name and quantity or proportion of such substance or derivative and in juxtaposition therewith the statement ''Warning—May be habit forming.'' Sixth, if it is a drug and is not designated solely by a name recognized in an official compendium, unless its label bears (1) the common or usual name of the drug, if such there be; and (2) 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, acetophenetidin, 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 clause (2) of this paragraph is impracticable, exemptions may be established by regulations promulgated by the department of public health, which conform to the regulations promulgated under the Federal Food, Drug and Cosmetic Act for the enforcement of federal law. Seventh, if its label fails to bear adequate directions for use and such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health or against unsafe dosage or methods or duration of administration or application in such manner and form as are necessary for the protection of the users. Eighth, if it is dangerous to health when used in the dosage or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof. Ninth, if it is an unstable drug and does not bear upon its container a label stating a date beyond which it should not be used. The words ''unstable drug'', as used herein, shall mean an antibiotic drug or any other drug upon the container of which the manufacturer has placed a label bearing an expiration date by the use of such words as ''not to be used after (specifying a date)'' or similar language specifying a date after which the drug should not be used. The labeling provisions of this section shall not apply to the compounding and dispensing of drugs on the oral or written prescription, as hereinafter defined, of a physician, dentist or veterinarian, except as above provided with respect to an unstable drug. In the case of food: First, if its labeling is false or misleading in any particular; Second, if it is offered for sale under the name of another food; Third, if it is in imitation or semblance of any other food; provided, that this paragraph shall not apply to an imitation of a food for which a standard of quality or identity has been adopted under the provisions of section one hundred and ninety-two nor to an imitation of any other food for which no standard has been established by law or regulation, if its label bears in type of uniform size and prominence, the word ''imitation'', and immediately thereafter the name of the food imitated; and, provided further, that this paragraph shall not be construed to permit the imitation of any food for which a standard has been established by law, other than as specifically provided herein; Fourth, if its container is so made, formed, or filled as to be misleading; Fifth, if the package containing it or its label bears any statement, design or device regarding the ingredients or the substances contained therein which is false or misleading in any particular; Sixth, if it is in package form and fails to bear a label showing (1) the name and place of business of the manufacturer, packer, or distributor; (2) an accurate statement of the quantity of the product in terms of weight, measure, or numerical count; provided that reasonable variations may be permitted, and exemptions as to small packages may be established for food products by regulations prescribed by the department; Seventh, if any word, statement, or other information required by or under authority of this chapter to appear on the label or other labeling is not prominently placed thereon with such conspicuousness, as compared with other words, statements, designs, or devices in the labeling, and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use; Eighth, if it purports to be or is represented as a food for which a standard of quality has been prescribed by the department and its quality falls below such standard, unless its label bears a statement as to its true nature; Ninth, if it purports to be or is represented as a food for which a definition and standard of identity or composition has been prescribed by the regulations of the department unless (1) it conforms to such definition and standard, and (2) its label bears the name of the food specified in the definition and standard and, insofar as may be required by such regulations, the common names of optional ingredients, other than spices, flavoring and coloring, present in such food; Tenth, if it purports to be or is represented as a food for which a standard or standards of fill of container have been prescribed by regulations of the department and it falls below the standard of fill of container, applicable thereto, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard; Eleventh, if it is not subject to the provision of paragraph Ninth unless its label bears (1) the common or usual name of the food in order of predominance, if any there be, and (2) in case it is fabricated from two or more ingredients, the common or usual name of each such ingredient; except that spices, flavorings, and colorings may, when authorized by the department, be designated as spices, flavorings, and colorings without naming each; provided that, to the extent that compliance with the requirements of this clause is impracticable, or results in deception or unfair competition, exemptions shall be established by regulations promulgated by the department; Twelfth, if it purports to be or is represented for special dietary uses, its label bears such information concerning its vitamin, mineral and other dietary properties as the department determines to be, and by regulations prescribes as, necessary in order to fully inform purchasers as to its value for such uses; Thirteenth, if it bears or contains any artificial flavoring, artificial coloring, or chemical preservative, unless it bears labeling stating that fact: provided that, to the extent that compliance with the requirements of this chapter is impracticable, exemptions shall be established by regulations promulgated by the department; Fourteenth, in the case of meat or meat food product or poultry or poultry products, if it fails to bear, directly thereon and on its containers, as the department may by regulations prescribe, the official inspection legend and establishment number of the establishment where the product was prepared, and, unrestricted by any of the foregoing, such other information as the department may require in such regulations to assure that it will not have false or misleading labeling. For the purposes of this section and section one hundred and eighty-seven A, the following terms shall have the following meanings:— ''Oral prescription'', that prescription of a physician, dentist or veterinarian which has been verbally transmitted to a pharmacist by said physician, dentist or veterinarian or his expressly authorized representative and immediately recorded by said pharmacist on a regular prescription form, and which contains the name and address of the prescriber, and the name of the expressly authorized representative, if any, the date of the prescription, the name and amount of the drug prescribed, the serial number given to the prescription by the pharmacist dispensing the same, the name of the pharmacist receiving the prescription, the name of the patient unless a veterinary prescription, the directions for use and any cautionary statements if stated in the prescription, and the number of times to be refilled. ''Written prescription'', that prescription which has been issued by a physician, dentist or veterinarian either on paper or electronically, and bears the handwritten or electronic signature and address of the prescriber, the date of the prescription, the name and amount of the drug prescribed, the name of the patient, directions for use, the number of times to be refilled, and any cautionary statements needed. ''Pharmacist'', a person duly registered under chapter one hundred and twelve and actively engaged as a practitioner or employed in an established and licensed place of business for the sale, compounding and dispensing of drugs. In the case of a cosmetic: First, if in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; Provided, that under clause (2) of this paragraph reasonable variations shall be permitted, and exemptions as to small packages shall be established by regulations promulgated by the department of public health. Second, if any word, statement, or other information required by or under authority of this chapter to appear on the label is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the label) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. Third, if its container is so made, formed, or filled as to be misleading. The department of public health shall promulgate regulations exempting from any labeling requirement of this chapter cosmetics which are in accordance with the practices of the trade, to be processed, labeled, or repackaged in substantial quantities at establishments other than those where originally processed or packaged, on condition that such cosmetics are not adulterated or misbranded under the provisions of this chapter upon removal from such processing, labeling, or repackaging establishment. In the case of a device: First, if it is dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended or suggested in the labeling thereof. Second, if it is in package form and it does not bear a label containing the name and place of business of the manufacturer, packer or distributor. Third, if it is in package form and it does not bear a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count. Reasonable variations shall be permitted, and exemptions as to small packages shall be established by regulations. Fourth, if the labeling thereof does not bear adequate directions for use, provided that where the requirement as applied to any device is not necessary for the protection of the public health, the commissioner shall promulgate regulations exempting such drug or device from such requirement. Fifth, if the labeling thereof does not bear such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form as are necessary for the protection of users. Sixth, if any word, statement or other information required to appear on the label or labeling thereof is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

Section 187. The term ''misbranded'' as used in this chapter shall apply to each drug, or article of food, or article which enters into the composition of food, the package or label of which bears any statement, design or device regarding such article or the ingredients or substance contained therein, which is false or misleading in any particular, and also to any food or drug product which is falsely branded as to the state or country where it was manufactured or produced.

For the purposes of said sections an article shall also be deemed to be misbranded:—

In the case of a drug: First, if it is so designated by the United States Food and Drug Administration, or if it is an imitation of or offered for sale under the name of another article. The department of public health shall maintain lists of drugs so designated as misbranded which shall be made available to physicians and pharmacists.

Second, if the contents of the package as originally put up have been removed, in whole or in part, and other contents placed therein.

Third, if its package or wrapper bears or contains any false or misleading statement, design, or device regarding the curative or therapeutic effect of such article or of any of the ingredients or substances contained therein.

Fourth, if in package form it fails to bear a label containing the name and place of business of the manufacturer, packer or distributor.

Fifth, if it is for use by man and contains any quantity of the narcotic or hypnotic substance alpha-eucaine, barbituric acid, beta-eucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marihuana, morphine, opium, paraldehyde, peyote or sulphonmethane; or any chemical derivative of any such substance, unless its label bears the name and quantity or proportion of such substance or derivative and in juxtaposition therewith the statement ''Warning—May be habit forming.''

Sixth, if it is a drug and is not designated solely by a name recognized in an official compendium, unless its label bears (1) the common or usual name of the drug, if such there be; and (2) 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, acetophenetidin, 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 clause (2) of this paragraph is impracticable, exemptions may be established by regulations promulgated by the department of public health, which conform to the regulations promulgated under the Federal Food, Drug and Cosmetic Act for the enforcement of federal law.

Seventh, if its label fails to bear adequate directions for use and such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health or against unsafe dosage or methods or duration of administration or application in such manner and form as are necessary for the protection of the users.

Eighth, if it is dangerous to health when used in the dosage or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof.

Ninth, if it is an unstable drug and does not bear upon its container a label stating a date beyond which it should not be used. The words ''unstable drug'', as used herein, shall mean an antibiotic drug or any other drug upon the container of which the manufacturer has placed a label bearing an expiration date by the use of such words as ''not to be used after (specifying a date)'' or similar language specifying a date after which the drug should not be used.

The labeling provisions of this section shall not apply to the compounding and dispensing of drugs on the oral or written prescription, as hereinafter defined, of a physician, dentist or veterinarian, except as above provided with respect to an unstable drug.

In the case of food: First, if its labeling is false or misleading in any particular;

Second, if it is offered for sale under the name of another food;

Third, if it is in imitation or semblance of any other food; provided, that this paragraph shall not apply to an imitation of a food for which a standard of quality or identity has been adopted under the provisions of section one hundred and ninety-two nor to an imitation of any other food for which no standard has been established by law or regulation, if its label bears in type of uniform size and prominence, the word ''imitation'', and immediately thereafter the name of the food imitated; and, provided further, that this paragraph shall not be construed to permit the imitation of any food for which a standard has been established by law, other than as specifically provided herein;

Fourth, if its container is so made, formed, or filled as to be misleading;

Fifth, if the package containing it or its label bears any statement, design or device regarding the ingredients or the substances contained therein which is false or misleading in any particular;

Sixth, if it is in package form and fails to bear a label showing (1) the name and place of business of the manufacturer, packer, or distributor;

(2) an accurate statement of the quantity of the product in terms of weight, measure, or numerical count; provided that reasonable variations may be permitted, and exemptions as to small packages may be established for food products by regulations prescribed by the department;

Seventh, if any word, statement, or other information required by or under authority of this chapter to appear on the label or other labeling is not prominently placed thereon with such conspicuousness, as compared with other words, statements, designs, or devices in the labeling, and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;

Eighth, if it purports to be or is represented as a food for which a standard of quality has been prescribed by the department and its quality falls below such standard, unless its label bears a statement as to its true nature;

Ninth, if it purports to be or is represented as a food for which a definition and standard of identity or composition has been prescribed by the regulations of the department unless (1) it conforms to such definition and standard, and (2) its label bears the name of the food specified in the definition and standard and, insofar as may be required by such regulations, the common names of optional ingredients, other than spices, flavoring and coloring, present in such food;

Tenth, if it purports to be or is represented as a food for which a standard or standards of fill of container have been prescribed by regulations of the department and it falls below the standard of fill of container, applicable thereto, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard;

Eleventh, if it is not subject to the provision of paragraph Ninth unless its label bears (1) the common or usual name of the food in order of predominance, if any there be, and (2) in case it is fabricated from two or more ingredients, the common or usual name of each such ingredient; except that spices, flavorings, and colorings may, when authorized by the department, be designated as spices, flavorings, and colorings without naming each; provided that, to the extent that compliance with the requirements of this clause is impracticable, or results in deception or unfair competition, exemptions shall be established by regulations promulgated by the department;

Twelfth, if it purports to be or is represented for special dietary uses, its label bears such information concerning its vitamin, mineral and other dietary properties as the department determines to be, and by regulations prescribes as, necessary in order to fully inform purchasers as to its value for such uses;

Thirteenth, if it bears or contains any artificial flavoring, artificial coloring, or chemical preservative, unless it bears labeling stating that fact: provided that, to the extent that compliance with the requirements of this chapter is impracticable, exemptions shall be established by regulations promulgated by the department;

Fourteenth, in the case of meat or meat food product or poultry or poultry products, if it fails to bear, directly thereon and on its containers, as the department may by regulations prescribe, the official inspection legend and establishment number of the establishment where the product was prepared, and, unrestricted by any of the foregoing, such other information as the department may require in such regulations to assure that it will not have false or misleading labeling.

For the purposes of this section and section one hundred and eighty-seven A, the following terms shall have the following meanings:—

''Oral prescription'', that prescription of a physician, dentist or veterinarian which has been verbally transmitted to a pharmacist by said physician, dentist or veterinarian or his expressly authorized representative and immediately recorded by said pharmacist on a regular prescription form, and which contains the name and address of the prescriber, and the name of the expressly authorized representative, if any, the date of the prescription, the name and amount of the drug prescribed, the serial number given to the prescription by the pharmacist dispensing the same, the name of the pharmacist receiving the prescription, the name of the patient unless a veterinary prescription, the directions for use and any cautionary statements if stated in the prescription, and the number of times to be refilled.

''Written prescription'', that prescription which has been issued by a physician, dentist or veterinarian either on paper or electronically, and bears the handwritten or electronic signature and address of the prescriber, the date of the prescription, the name and amount of the drug prescribed, the name of the patient, directions for use, the number of times to be refilled, and any cautionary statements needed.

''Pharmacist'', a person duly registered under chapter one hundred and twelve and actively engaged as a practitioner or employed in an established and licensed place of business for the sale, compounding and dispensing of drugs.

In the case of a cosmetic: First, if in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; Provided, that under clause (2) of this paragraph reasonable variations shall be permitted, and exemptions as to small packages shall be established by regulations promulgated by the department of public health.

Second, if any word, statement, or other information required by or under authority of this chapter to appear on the label is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the label) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

Third, if its container is so made, formed, or filled as to be misleading.

The department of public health shall promulgate regulations exempting from any labeling requirement of this chapter cosmetics which are in accordance with the practices of the trade, to be processed, labeled, or repackaged in substantial quantities at establishments other than those where originally processed or packaged, on condition that such cosmetics are not adulterated or misbranded under the provisions of this chapter upon removal from such processing, labeling, or repackaging establishment.

In the case of a device: First, if it is dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended or suggested in the labeling thereof.

Second, if it is in package form and it does not bear a label containing the name and place of business of the manufacturer, packer or distributor.

Third, if it is in package form and it does not bear a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count. Reasonable variations shall be permitted, and exemptions as to small packages shall be established by regulations.

Fourth, if the labeling thereof does not bear adequate directions for use, provided that where the requirement as applied to any device is not necessary for the protection of the public health, the commissioner shall promulgate regulations exempting such drug or device from such requirement.

Fifth, if the labeling thereof does not bear such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form as are necessary for the protection of users.

Sixth, if any word, statement or other information required to appear on the label or labeling thereof is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.