Louisiana Revised Statutes 40:617 – Misbranded drugs and devices
Terms Used In Louisiana Revised Statutes 40:617
- Cosmetic: includes all substances and preparations intended for cleansing, altering the appearance of, or promoting the attractiveness of a person. See Louisiana Revised Statutes 40:602
- Department: means the Louisiana Department of Health and "secretary" means the secretary thereof. See Louisiana Revised Statutes 40:602
- Device: includes all devices intended for use in diagnosis, treatment, or prevention of disease in man or beast, or intended to affect the structure of any function of the body. See Louisiana Revised Statutes 40:602
- Drug: includes all substances and preparations recognized in the official compendium, as herein defined. See Louisiana Revised Statutes 40:602
- Food: includes all substances and preparations used for or entering into the composition of food, drink, confectionery, chewing gum, or condiment for man or beast. See Louisiana Revised Statutes 40:602
- Label: means the principal display or displays of written, printed, or graphic matter upon any food, drug, device, or cosmetic, or the immediate container thereof, or upon the outside container or wrapper, if any, of the retail package of any food, drug, device, or cosmetic. See Louisiana Revised Statutes 40:602
- Labeling: includes all labels and other written, printed, and graphic matter, in any form whatsoever, accompanying any food, drug, device, or cosmetic. See Louisiana Revised Statutes 40:602
- Medical profession: means the legalized profession of the healing art. See Louisiana Revised Statutes 40:602
- Official compendium: means the United States Pharmacopoeia, Homeopathic Pharmacopoeia of the United States, National Formulary, or any supplement of any of them, official at the time any drug, to which the provisions thereof relate, is introduced into commerce. See Louisiana Revised Statutes 40:602
- Scientific opinion: means the opinion, within their respective fields, of competent pharmacologists, physiologists, or toxicologists. See Louisiana Revised Statutes 40:602
A. A drug or device is considered misbranded if it has been found to be such by any department of the United States government, or:
(1) If its labeling is false or misleading in any particular. Any representation concerning any effect of a drug or device is considered false for purposes of this Paragraph if the representation is not supported by demonstrable scientific facts or substantial and reliable medical or scientific opinion.
(2) If it is dangerous to health under the conditions of use prescribed in the labeling or advertising thereof.
(3) If it is in package form and it does not bear a label containing: (a) the name and place of business of the manufacturer, packer, seller, or distributor; and (b) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Under Subparagraph (b) of this Paragraph reasonable variations shall be permitted and exemptions as to small packages shall be established by regulations prescribed by the department where compliance with the provisions would be impracticable.
(3.1) If it is a prescription drug bearing the following words “Caution: Federal law prohibits dispensing without a prescription”, and (a) the manufacturer, packager, seller, or distributor of any prescription drug sold, delivered, or offered for sale in the state of Louisiana after January 1, 1976, does not have printed on the label on the immediate container of the drug the name and place of business of the manufacturer and, if different, the name and place of business of the packer or distributor of the final dosage form of the drug; and (b) the manufacturer, packager, seller, or distributor does not have printed on the label on the final dosage form an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Under Subparagraph (b) of this Paragraph reasonable variations shall be permitted and exemptions as to small packages shall be established by regulations prescribed by the department where compliance with the provisions would be impracticable. Wholesalers or jobbers who sell prescription drugs only to retailers or institutions shall be exempt from the provisions of this Paragraph. However, nothing contained in the provisions of this Paragraph shall affect the labeling requirements of a prescription label placed on a container by a pharmacist in the process of dispensing a prescription drug.
(3.2) If it contains any quantity of amyl nitrite, isopentyl nitrite or any of their isomers, or butyl nitrite, n-butyl nitrite, isobutyl nitrite or any of their isomers, and is not labeled “Caution: Louisiana Law prohibits dispensing without a prescription” and its sale is not restricted to the prescription of a physician, except that amyl nitrite may be labeled in accordance with labeling requirements of the Federal Food, Drug and Cosmetic Law.
(4) If any information required on the label under any provision of this Part is not prominently placed thereon in such a manner as to be easily seen and in such terms as to be readily understood by purchasers and users of the articles under customary conditions of purchase and use. Due consideration shall be given to the size of the package.
(5) If it is for use by man and contains any quantity of any of the following narcotic or hypnotic substances and, except when dispensed on the written order of a member of the medical profession, its label fails to bear the name and quantity or proportion of the substance or derivative and in juxtaposition therewith the statement “Warning–May be Habit Forming”: Alpha eucaine, barbituric acid, beta eucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marihuana, morphine, opium, paraldehyde, peyote, sulphomethane, or any substance chemically derived therefrom, except derivatives of coca leaves which do not contain cocaine, ecgonine (or substances from which cocaine or ecgonine may be synthesized or made) or any other narcotic or hypnotic substance designated as habit forming by regulations of the department, unless the derivative is clearly not habit forming.
(6) If it is a drug and is not designated solely by a name recognized by an official compendium or if its label has been disapproved by the United States government or the department.
(7) If its name is recognized in an official compendium, or if it purports to be a drug the name of which is so recognized, and it is not packaged and labeled as prescribed therein.
(8) If it is a drug liable to deterioration and is not packaged in the form or manner required by department regulations for the protection of public health or its label does not bear a statement of those precautions.
No such regulation shall be established for any drug recognized in the official compendium until the department shall have informed the appropriate body charged with the revision of the compendium of the need for the packaging or labeling requirements and that body shall have failed within a reasonable time to prescribe those requirements.
(9) If it is a drug and its container is so made, formed, or filled as to mislead the purchaser.
(10) If it is a drug and it is an imitation of another drug.
(11) If it is a drug and it is offered for sale under the name of another drug.
B. When construing and enforcing the provisions of this Part with respect to labeling and advertisements, the term “antiseptic” has the same meaning as the word “germicide”, except, however, in the case of a drug purporting to be, or represented as, an antiseptic for inhibitory use as a wet dressing, ointment, dusting powder, or for such other use as involves prolonged contact with the body.
Amended by Acts 1975, No. 524, §1; Acts 1978, No. 140, §1; Acts 1978, No. 786, §5, eff. July 17, 1978.