State Codes and Statutes

Statutes > Rhode-island > Title-21 > Chapter-21-31 > 21-31-2

SECTION 21-31-2

   § 21-31-2  Definitions. – For the purpose of this chapter:

   (1) "Advertisement" means all representations disseminated inany manner or by any means, other than by labeling, for the purpose ofinducing, or which are likely to induce, directly or indirectly, the purchaseof food, drugs, devices, or cosmetics.

   (2) "Contaminated with filth" applies to any food, drug,device, or cosmetic not securely protected from dust, dirt, and, as far as maybe necessary by all reasonable means, from all foreign or injuriouscontaminations.

   (3) "Cosmetics" means: (i) articles intended to be rubbed,poured, sprinkled, or sprayed on, introduced into, or applied to the humanbodyor any part of the body for cleansing, beautifying, promoting attractiveness,or altering the appearance, and (ii) articles intended for use as a componentof any articles described in this subdivision, except that this term shall notinclude soap.

   (4) "Device" (except when used in subdivision (23) of thissection and in §§ 21-31-3(10), 21-31-11(6), 21-31-15(a)(3), and21-31-18(3)) means instruments, apparatus, and contrivances, including theircomponents, parts, and accessories, intended: (i) for use in the diagnosis,cure, mitigation, treatment, or prevention of disease in humans or otheranimals; or (ii) to affect the structure or any function of the body of humansor other animals.

   (5) "Director" means the director of health.

   (6) "Distressed merchandise" means any food which has had thelabel lost or which has been subjected to possible damage due to accident,fire, flood, adverse weather, or to any other similar cause, and which may havebeen rendered unsafe or unsuitable for human or animal consumption or use.

   (7) "Dosage form" means the form of the completed drugproduct (such as tablet, syrup, or suppository).

   (8) "Drug" means: (i) articles recognized in the officialUnited States Pharmacopoeia, official Homeopathic Pharmacopoeia of the UnitedStates, or official National Formulary, or any supplement to any of them; (ii)articles intended for use in the diagnosis, cure, mitigation, treatment, orprevention of disease in humans or other animals; (iii) articles (other thanfood) intended to affect the structure or any function of the body of humans orother animals; and (iv) articles intended for use as a component of any articlespecified in paragraphs (i), (ii) or (iii) of this subdivision; but does notinclude devices or their components, parts, or accessories.

   (9) "Drug product" means a dosage form containing one or moreactive therapeutic ingredients along with other substances included during themanufacturing process.

   (10) "Equivalent and interchangeable" means having the samegeneric name, dosage form, and labeled potency, meeting standards of the UnitedStates Pharmacopoeia or National Formulary, or their successors, if applicable,and not found in violation of the requirements of the United States Food andDrug Administration, or its successor agency, or the department of health.

   (ii) "Generic" means the chemical or established name of adrug or drug product.

   (11) "Federal Act" means the Federal Food, Drug, and CosmeticAct, 21 U.S.C. § 301 et seq.

   (12)"Food" means: (i) articles used for food or drink forhumans or other animals, (ii) chewing gum, and (iii) articles used forcomponents of any article described in this subdivision.

   (13) "Label" means a display of written, printed, or graphicmatter upon the immediate container of any article; and a requirement made byor under authority of this chapter that any word, statement, or otherinformation appearing on the label shall not be considered to be complied withunless the word, statement, or other information also appears on the outsidecontainer or wrapper, if any, of the retail package of the article, or iseasily legible through the outside container or wrapper.

   (ii) "Immediate container" does not include package liners.

   (iii) "Labeling" means all labels and other written, printed,or graphic matter: (A) upon an article or any of its containers or wrappers, or(B) accompanying the article.

   (iv) If an article is alleged to be misbranded because thelabeling is misleading, or if an advertisement is alleged to be false becauseit is misleading, then in determining whether the labeling or advertisement ismisleading there shall be taken into account (among other things) not onlyrepresentations made or suggested by statement, word, design, device, sound, orin any combination of them, but also the extent to which the labeling oradvertisement fails to reveal facts material in the light of therepresentations or material with respect to consequences which may result fromthe use of the article to which the labeling or advertisement relates under theconditions of use prescribed in the labeling or advertisement or under theconditions of use that are customary or usual.

   (14) "Native" means a product harvested in Rhode Island andis limited to the following:

   (i) "Bay scallop" means Argopecten irradians.

   (ii) "Bay quahog" means Mercenaria mercenaria.

   (iii) "Steamer clams" means Mya arenaria.

   (iv) "Mussels" means Mytilus edulis.

   (v) "Oysters" means Crassostrea virginica.

   (15) "New drug" means: (i) any drug the composition of whichis such that the drug is not generally recognized among experts qualified byscientific training and experience to evaluate the safety of drugs as safe foruse under conditions prescribed, recommended, or suggested in the labeling ofit; or (ii) any drug the composition of which is such that the drug, as aresult of investigations to determine its safety for use under those conditionshas become so recognized, but which has not, otherwise than in theinvestigations, been used to a material extent or for a material time underthose conditions.

   (16) "Official compendium" means the official United StatesPharmacopoeia, official Homeopathic Pharmacopoeia of the United States,official National Formulary, or any supplement to any of them.

   (17) "Patient" means, as the case may be: (i) the individualmedically requiring a drug, for whom a drug is prescribed; or (ii) the owner orthe agent of the owner of an animal medically requiring a drug, for which adrug is prescribed.

   (18) "Person" includes individual, partnership, corporation,and association.

   (19) "Pharmacist" means a person duly registered with theboard of pharmacy as a compounder, dispenser, or supplier of drugs uponprescription, including registered assistant pharmacists as defined by law.

   (20) "Pharmacy" means a place where drugs, medicines, orpoisons are sold at retail or where prescriptions of physicians, dentists,veterinarians, and other practitioners authorized to issue prescriptions fordrugs, medicines, and poisons are compounded, dispensed, supplied or sold.

   (21) "Practitioner" means a person authorized by law topractice medicine, dentistry, osteopathy, chiropody, or veterinary medicine inthis state.

   (22) "Prescription" means an order, issued in good faith inthe course of professional practice only, by a practitioner to a pharmacist fora drug for a particular patient, which specifies the date of its issue, thename and address of the practitioner, the name and address of the patient (and,if the drug is prescribed for an animal, the species of the animal), the nameand quantity of the drug prescribed, directions for the use of the drug, andthe signature of the practitioner; provided, that a prescription received byword of mouth, telephone, or other means of communication shall be reducedpromptly to writing by the pharmacist in the form prescribed in thissubdivision, and the record so made shall constitute the original prescriptionto be filed and preserved by the pharmacist; and, provided, further, that anyrefill authorization received by word of mouth, telephone, or other means ofcommunication shall be reduced promptly to writing by the pharmacist, with thedate of it on the face or on the reverse side of the original prescription.

   (23) The representation of a drug, in its labeling oradvertisement, as an antiseptic shall be considered to be a representation thatit is a germicide, except in the case of a drug purporting to be, orrepresented as, an antiseptic for inhibitory use as a wet dressing, ointment,dusting powder, or any other use that involves prolonged contact with the body.

   (24) The provisions of this chapter regarding the selling offood, drugs, devices, or cosmetics shall be considered to include themanufacture, production, processing, packing, exposure, offer, possession, andholding of any article for sale, and the sale, dispensing, and giving of anyarticle, and the supplying or applying of the articles in the conduct of anyfood, drug, or cosmetic establishment.

State Codes and Statutes

Statutes > Rhode-island > Title-21 > Chapter-21-31 > 21-31-2

SECTION 21-31-2

   § 21-31-2  Definitions. – For the purpose of this chapter:

   (1) "Advertisement" means all representations disseminated inany manner or by any means, other than by labeling, for the purpose ofinducing, or which are likely to induce, directly or indirectly, the purchaseof food, drugs, devices, or cosmetics.

   (2) "Contaminated with filth" applies to any food, drug,device, or cosmetic not securely protected from dust, dirt, and, as far as maybe necessary by all reasonable means, from all foreign or injuriouscontaminations.

   (3) "Cosmetics" means: (i) articles intended to be rubbed,poured, sprinkled, or sprayed on, introduced into, or applied to the humanbodyor any part of the body for cleansing, beautifying, promoting attractiveness,or altering the appearance, and (ii) articles intended for use as a componentof any articles described in this subdivision, except that this term shall notinclude soap.

   (4) "Device" (except when used in subdivision (23) of thissection and in §§ 21-31-3(10), 21-31-11(6), 21-31-15(a)(3), and21-31-18(3)) means instruments, apparatus, and contrivances, including theircomponents, parts, and accessories, intended: (i) for use in the diagnosis,cure, mitigation, treatment, or prevention of disease in humans or otheranimals; or (ii) to affect the structure or any function of the body of humansor other animals.

   (5) "Director" means the director of health.

   (6) "Distressed merchandise" means any food which has had thelabel lost or which has been subjected to possible damage due to accident,fire, flood, adverse weather, or to any other similar cause, and which may havebeen rendered unsafe or unsuitable for human or animal consumption or use.

   (7) "Dosage form" means the form of the completed drugproduct (such as tablet, syrup, or suppository).

   (8) "Drug" means: (i) articles recognized in the officialUnited States Pharmacopoeia, official Homeopathic Pharmacopoeia of the UnitedStates, or official National Formulary, or any supplement to any of them; (ii)articles intended for use in the diagnosis, cure, mitigation, treatment, orprevention of disease in humans or other animals; (iii) articles (other thanfood) intended to affect the structure or any function of the body of humans orother animals; and (iv) articles intended for use as a component of any articlespecified in paragraphs (i), (ii) or (iii) of this subdivision; but does notinclude devices or their components, parts, or accessories.

   (9) "Drug product" means a dosage form containing one or moreactive therapeutic ingredients along with other substances included during themanufacturing process.

   (10) "Equivalent and interchangeable" means having the samegeneric name, dosage form, and labeled potency, meeting standards of the UnitedStates Pharmacopoeia or National Formulary, or their successors, if applicable,and not found in violation of the requirements of the United States Food andDrug Administration, or its successor agency, or the department of health.

   (ii) "Generic" means the chemical or established name of adrug or drug product.

   (11) "Federal Act" means the Federal Food, Drug, and CosmeticAct, 21 U.S.C. § 301 et seq.

   (12)"Food" means: (i) articles used for food or drink forhumans or other animals, (ii) chewing gum, and (iii) articles used forcomponents of any article described in this subdivision.

   (13) "Label" means a display of written, printed, or graphicmatter upon the immediate container of any article; and a requirement made byor under authority of this chapter that any word, statement, or otherinformation appearing on the label shall not be considered to be complied withunless the word, statement, or other information also appears on the outsidecontainer or wrapper, if any, of the retail package of the article, or iseasily legible through the outside container or wrapper.

   (ii) "Immediate container" does not include package liners.

   (iii) "Labeling" means all labels and other written, printed,or graphic matter: (A) upon an article or any of its containers or wrappers, or(B) accompanying the article.

   (iv) If an article is alleged to be misbranded because thelabeling is misleading, or if an advertisement is alleged to be false becauseit is misleading, then in determining whether the labeling or advertisement ismisleading there shall be taken into account (among other things) not onlyrepresentations made or suggested by statement, word, design, device, sound, orin any combination of them, but also the extent to which the labeling oradvertisement fails to reveal facts material in the light of therepresentations or material with respect to consequences which may result fromthe use of the article to which the labeling or advertisement relates under theconditions of use prescribed in the labeling or advertisement or under theconditions of use that are customary or usual.

   (14) "Native" means a product harvested in Rhode Island andis limited to the following:

   (i) "Bay scallop" means Argopecten irradians.

   (ii) "Bay quahog" means Mercenaria mercenaria.

   (iii) "Steamer clams" means Mya arenaria.

   (iv) "Mussels" means Mytilus edulis.

   (v) "Oysters" means Crassostrea virginica.

   (15) "New drug" means: (i) any drug the composition of whichis such that the drug is not generally recognized among experts qualified byscientific training and experience to evaluate the safety of drugs as safe foruse under conditions prescribed, recommended, or suggested in the labeling ofit; or (ii) any drug the composition of which is such that the drug, as aresult of investigations to determine its safety for use under those conditionshas become so recognized, but which has not, otherwise than in theinvestigations, been used to a material extent or for a material time underthose conditions.

   (16) "Official compendium" means the official United StatesPharmacopoeia, official Homeopathic Pharmacopoeia of the United States,official National Formulary, or any supplement to any of them.

   (17) "Patient" means, as the case may be: (i) the individualmedically requiring a drug, for whom a drug is prescribed; or (ii) the owner orthe agent of the owner of an animal medically requiring a drug, for which adrug is prescribed.

   (18) "Person" includes individual, partnership, corporation,and association.

   (19) "Pharmacist" means a person duly registered with theboard of pharmacy as a compounder, dispenser, or supplier of drugs uponprescription, including registered assistant pharmacists as defined by law.

   (20) "Pharmacy" means a place where drugs, medicines, orpoisons are sold at retail or where prescriptions of physicians, dentists,veterinarians, and other practitioners authorized to issue prescriptions fordrugs, medicines, and poisons are compounded, dispensed, supplied or sold.

   (21) "Practitioner" means a person authorized by law topractice medicine, dentistry, osteopathy, chiropody, or veterinary medicine inthis state.

   (22) "Prescription" means an order, issued in good faith inthe course of professional practice only, by a practitioner to a pharmacist fora drug for a particular patient, which specifies the date of its issue, thename and address of the practitioner, the name and address of the patient (and,if the drug is prescribed for an animal, the species of the animal), the nameand quantity of the drug prescribed, directions for the use of the drug, andthe signature of the practitioner; provided, that a prescription received byword of mouth, telephone, or other means of communication shall be reducedpromptly to writing by the pharmacist in the form prescribed in thissubdivision, and the record so made shall constitute the original prescriptionto be filed and preserved by the pharmacist; and, provided, further, that anyrefill authorization received by word of mouth, telephone, or other means ofcommunication shall be reduced promptly to writing by the pharmacist, with thedate of it on the face or on the reverse side of the original prescription.

   (23) The representation of a drug, in its labeling oradvertisement, as an antiseptic shall be considered to be a representation thatit is a germicide, except in the case of a drug purporting to be, orrepresented as, an antiseptic for inhibitory use as a wet dressing, ointment,dusting powder, or any other use that involves prolonged contact with the body.

   (24) The provisions of this chapter regarding the selling offood, drugs, devices, or cosmetics shall be considered to include themanufacture, production, processing, packing, exposure, offer, possession, andholding of any article for sale, and the sale, dispensing, and giving of anyarticle, and the supplying or applying of the articles in the conduct of anyfood, drug, or cosmetic establishment.


State Codes and Statutes

State Codes and Statutes

Statutes > Rhode-island > Title-21 > Chapter-21-31 > 21-31-2

SECTION 21-31-2

   § 21-31-2  Definitions. – For the purpose of this chapter:

   (1) "Advertisement" means all representations disseminated inany manner or by any means, other than by labeling, for the purpose ofinducing, or which are likely to induce, directly or indirectly, the purchaseof food, drugs, devices, or cosmetics.

   (2) "Contaminated with filth" applies to any food, drug,device, or cosmetic not securely protected from dust, dirt, and, as far as maybe necessary by all reasonable means, from all foreign or injuriouscontaminations.

   (3) "Cosmetics" means: (i) articles intended to be rubbed,poured, sprinkled, or sprayed on, introduced into, or applied to the humanbodyor any part of the body for cleansing, beautifying, promoting attractiveness,or altering the appearance, and (ii) articles intended for use as a componentof any articles described in this subdivision, except that this term shall notinclude soap.

   (4) "Device" (except when used in subdivision (23) of thissection and in §§ 21-31-3(10), 21-31-11(6), 21-31-15(a)(3), and21-31-18(3)) means instruments, apparatus, and contrivances, including theircomponents, parts, and accessories, intended: (i) for use in the diagnosis,cure, mitigation, treatment, or prevention of disease in humans or otheranimals; or (ii) to affect the structure or any function of the body of humansor other animals.

   (5) "Director" means the director of health.

   (6) "Distressed merchandise" means any food which has had thelabel lost or which has been subjected to possible damage due to accident,fire, flood, adverse weather, or to any other similar cause, and which may havebeen rendered unsafe or unsuitable for human or animal consumption or use.

   (7) "Dosage form" means the form of the completed drugproduct (such as tablet, syrup, or suppository).

   (8) "Drug" means: (i) articles recognized in the officialUnited States Pharmacopoeia, official Homeopathic Pharmacopoeia of the UnitedStates, or official National Formulary, or any supplement to any of them; (ii)articles intended for use in the diagnosis, cure, mitigation, treatment, orprevention of disease in humans or other animals; (iii) articles (other thanfood) intended to affect the structure or any function of the body of humans orother animals; and (iv) articles intended for use as a component of any articlespecified in paragraphs (i), (ii) or (iii) of this subdivision; but does notinclude devices or their components, parts, or accessories.

   (9) "Drug product" means a dosage form containing one or moreactive therapeutic ingredients along with other substances included during themanufacturing process.

   (10) "Equivalent and interchangeable" means having the samegeneric name, dosage form, and labeled potency, meeting standards of the UnitedStates Pharmacopoeia or National Formulary, or their successors, if applicable,and not found in violation of the requirements of the United States Food andDrug Administration, or its successor agency, or the department of health.

   (ii) "Generic" means the chemical or established name of adrug or drug product.

   (11) "Federal Act" means the Federal Food, Drug, and CosmeticAct, 21 U.S.C. § 301 et seq.

   (12)"Food" means: (i) articles used for food or drink forhumans or other animals, (ii) chewing gum, and (iii) articles used forcomponents of any article described in this subdivision.

   (13) "Label" means a display of written, printed, or graphicmatter upon the immediate container of any article; and a requirement made byor under authority of this chapter that any word, statement, or otherinformation appearing on the label shall not be considered to be complied withunless the word, statement, or other information also appears on the outsidecontainer or wrapper, if any, of the retail package of the article, or iseasily legible through the outside container or wrapper.

   (ii) "Immediate container" does not include package liners.

   (iii) "Labeling" means all labels and other written, printed,or graphic matter: (A) upon an article or any of its containers or wrappers, or(B) accompanying the article.

   (iv) If an article is alleged to be misbranded because thelabeling is misleading, or if an advertisement is alleged to be false becauseit is misleading, then in determining whether the labeling or advertisement ismisleading there shall be taken into account (among other things) not onlyrepresentations made or suggested by statement, word, design, device, sound, orin any combination of them, but also the extent to which the labeling oradvertisement fails to reveal facts material in the light of therepresentations or material with respect to consequences which may result fromthe use of the article to which the labeling or advertisement relates under theconditions of use prescribed in the labeling or advertisement or under theconditions of use that are customary or usual.

   (14) "Native" means a product harvested in Rhode Island andis limited to the following:

   (i) "Bay scallop" means Argopecten irradians.

   (ii) "Bay quahog" means Mercenaria mercenaria.

   (iii) "Steamer clams" means Mya arenaria.

   (iv) "Mussels" means Mytilus edulis.

   (v) "Oysters" means Crassostrea virginica.

   (15) "New drug" means: (i) any drug the composition of whichis such that the drug is not generally recognized among experts qualified byscientific training and experience to evaluate the safety of drugs as safe foruse under conditions prescribed, recommended, or suggested in the labeling ofit; or (ii) any drug the composition of which is such that the drug, as aresult of investigations to determine its safety for use under those conditionshas become so recognized, but which has not, otherwise than in theinvestigations, been used to a material extent or for a material time underthose conditions.

   (16) "Official compendium" means the official United StatesPharmacopoeia, official Homeopathic Pharmacopoeia of the United States,official National Formulary, or any supplement to any of them.

   (17) "Patient" means, as the case may be: (i) the individualmedically requiring a drug, for whom a drug is prescribed; or (ii) the owner orthe agent of the owner of an animal medically requiring a drug, for which adrug is prescribed.

   (18) "Person" includes individual, partnership, corporation,and association.

   (19) "Pharmacist" means a person duly registered with theboard of pharmacy as a compounder, dispenser, or supplier of drugs uponprescription, including registered assistant pharmacists as defined by law.

   (20) "Pharmacy" means a place where drugs, medicines, orpoisons are sold at retail or where prescriptions of physicians, dentists,veterinarians, and other practitioners authorized to issue prescriptions fordrugs, medicines, and poisons are compounded, dispensed, supplied or sold.

   (21) "Practitioner" means a person authorized by law topractice medicine, dentistry, osteopathy, chiropody, or veterinary medicine inthis state.

   (22) "Prescription" means an order, issued in good faith inthe course of professional practice only, by a practitioner to a pharmacist fora drug for a particular patient, which specifies the date of its issue, thename and address of the practitioner, the name and address of the patient (and,if the drug is prescribed for an animal, the species of the animal), the nameand quantity of the drug prescribed, directions for the use of the drug, andthe signature of the practitioner; provided, that a prescription received byword of mouth, telephone, or other means of communication shall be reducedpromptly to writing by the pharmacist in the form prescribed in thissubdivision, and the record so made shall constitute the original prescriptionto be filed and preserved by the pharmacist; and, provided, further, that anyrefill authorization received by word of mouth, telephone, or other means ofcommunication shall be reduced promptly to writing by the pharmacist, with thedate of it on the face or on the reverse side of the original prescription.

   (23) The representation of a drug, in its labeling oradvertisement, as an antiseptic shall be considered to be a representation thatit is a germicide, except in the case of a drug purporting to be, orrepresented as, an antiseptic for inhibitory use as a wet dressing, ointment,dusting powder, or any other use that involves prolonged contact with the body.

   (24) The provisions of this chapter regarding the selling offood, drugs, devices, or cosmetics shall be considered to include themanufacture, production, processing, packing, exposure, offer, possession, andholding of any article for sale, and the sale, dispensing, and giving of anyarticle, and the supplying or applying of the articles in the conduct of anyfood, drug, or cosmetic establishment.