reglab/statecodes huggingface dataset:
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1127 - Quantity of Contents, Use of Largest Units [Formerly 49:4.0130]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Except as
				provided for in paragraph §1129, a statement of the quantity of a drug in the
				terms of weight or measure applicable to such drug under the provisions of
				§1119 shall express the number of the
				largest unit specified in
				§1123 which is contained in the package.
				For example: the statement on the label of a package which contains one pint of
				a drug shall be "1 pint" and not "16 fluid ounces". Where the number is a whole
				number and a fraction, there may be substituted for the fraction its equivalent
				in smaller units if any smaller unit is specified in
				§1123 For example: "1 1/4 pounds" may be
				expressed as "1 pound 4 ounces". The stated number of any unit smaller than the
				largest unit (as specified in §1123) contained in the package shall not equal
				or exceed the number of these smaller units which are contained in the next
				larger unit so specified. For example: instead of "1 quart 16 fluid ounces",
				the statement shall be " 1 1/2 quarts", or " 1 quart 1 pint".
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1129 - Quantity of Contents, Customary Usage [Formerly 49:4.0140]

Current through Register Vol. 50, No. 6, June 20, 2024
A. In the case of a drug with respect to
				which there exists an established custom of stating the quantity of the
				contents as a fraction of a unit, which unit is larger than the quantity
				contained in the package; or as units smaller than the largest unit contained
				therein; the statement may be made in accordance with such custom if it is
				informative to consumers.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1131 - Quantity of Contents, Minimum Quantity [Formerly 49:4.0150]

Current through Register Vol. 50, No. 6, June 20, 2024
A. The statement of
				the quantity of the contents of the package of a drug or device shall express
				the minimum quantity, or the average quantity. If the statement is not so
				qualified as to show definitely that the quantity expressed is the minimum
				quantity, the statement shall be considered to mean the average quantity,
				except when the drug is in ampoules. When in ampoules, the statement of the
				quantity of the contents of a drug shall be considered to express the minimum
				quantity.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1133 - Quantity of Contents, Variation from Minimum Quantity [Formerly 49:4.0160]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Where the
				statement expresses the minimum quantity, no variation below the stated minimum
				shall be permitted except variations below the stated weight or measure of a
				drug caused by ordinary and customary exposure, after the drug is introduced
				into commerce, to conditions which normally occur in good distribution practice
				and which unavoidably result in decreased weight or measure. Variations above
				the stated minimum shall not be unreasonably large. In the case of a liquid
				drug in ampoules the variation above the stated measure shall comply with the
				excess volume prescribed by any official compendium for filling of
				ampoules.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1135 - Quantity of Contents, Where Minimum Quantity Not Expressed [Formerly 49:4.0170]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Where
				the statement does not express the minimum quantity, variations shall be
				permitted:
1. when caused by ordinary and
				customary exposure, after the drug is introduced into commerce, to conditions
				which normally occur in good distribution practice and which unavoidably result
				in change of weight or measure;
2.
				when caused by unavoidable deviations in weighing, measuring or counting the
				contents of individual packages, which occur in good packing practices.
				However, under this provision variations shall not be permitted to such an
				extent that the average of the quantities in the package comprising a shipment
				or other delivery of the drug or device is below the quantity stated; and no
				unreasonable shortage in any package shall be permitted, even though overages
				in other packages in the same shipment or delivery compensate for such
				shortage.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1137 - Quantity of Contents, Variations [Formerly 49:4.0180]

Current through Register Vol. 50, No. 6, June 20, 2024
A. The extent of variations from the stated
				quantity of the contents permissible under
				§1133 and
				§1135 shall be determined by the facts in
				the case of each shipment or other delivery.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1141 - Quantity of Contents, Statements, Exemptions [Formerly 49:4.0190]

Current through Register Vol. 50, No. 6, June 20, 2024
A. The label of a
				drug or device shall be exempt from compliance with the requirements of
				R.S.
				40:617 (A) (3) (b) if:
1. the statement of the quantity of the
				contents, as expressed in terms applicable to such drug or device under the
				provisions of §1117,
				§1119 and §1121, together with all other
				words, statements and information required by or under authority of the Act to
				appear on the label of such drug or device cannot, because of insufficient area
				for larger label space, be placed on the labels so as to comply with the
				requirements of
				R.S.
				40:617 (A) (3) and regulations promulgated
				thereunder; or
2. the quantity of
				the contents of the package, as expressed in terms of numerical count in
				compliance with
				§1119 or
				§1121 is less than six units, and the
				units can be easily counted without opening the package.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1143 - Misbranding, Prominence and Conspicuousness of Words [Formerly 49:4.0200]

Current through Register Vol. 50, No. 6, June 20, 2024
A. A word,
				statement or other information required by or under authority of the Act to
				appear on the label shall be deemed to lack that prominence and conspicuousness
				required by 617(A)(4) of the Act by reason (among other reasons) if:
1. the failure of such word, statement or
				information to appear on the part or panel or the label which is presented or
				displayed under customary conditions of purchase; or
2. the failure of such word, statement or
				information to appear on two or more parts or panels of the label, each of
				which has sufficient space therefor, and each of which is so designed as to
				render it likely to be, under customary conditions or purchases, the part or
				panel displayed; or
3. the failure
				of the label to extend over the area of the container or package available for
				extension of the label so as to provide sufficient label space for the
				prominent placing of such word;
4.
				insufficiency of label space (for the prominent placing of such word, statement
				or information) resulting from the use of label space for any word, statement,
				design or device which is not required by or under authority of the Act to
				appear on the label; or
5.
				insufficiency of label space (for the prominent placing of such word, statement
				or information) resulting from the use of label space to give materially
				greater conspicuousness to any other word, statement or information, or to any
				design or device; or
6. smallness
				or style of type in which such word, statement or information appears,
				insufficient background contrast, obscuring designs or vignettes, or crowding
				with other written, printed or graphic matter.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1145 - Labeling Exemptions Prohibited [Formerly 49:4.0210]

Current through Register Vol. 50, No. 6, June 20, 2024
A. No exemption depending on insufficiency of
				label space, as prescribed in relations
				§1141 and
				§1185 promulgated under
				R.S.
				40:617 (A) (3), (6) and (7) shall apply if
				such insufficiency is caused by:
1. the use
				of label space for any word statement, design or device which is not required
				by or under authority of the Act or these regulations to appear on the label;
				or
2. the use of label space to
				give greater conspicuousness to any word, statement or other information than
				is required by 617(A)(3) of the Act; or
3. the use of label space for any
				representation in a foreign language.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1147 - English Language Required [Formerly 49:4.0220]

Current through Register Vol. 50, No. 6, June 20, 2024
A. All words, statements and other
				information required by or under authority of the Act to appear on the label or
				labeling shall appear thereon in the English language.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1149 - Foreign Language Labeling [Formerly 49:4.0230]

Current through Register Vol. 50, No. 6, June 20, 2024
A. If the label or labeling contains any re
				presentation in a foreign language, all words, statements, and other
				information required by or under authority of the Act to appear on the label or
				labeling shall appear thereon in the foreign language.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1151 - Official Names Required [Formerly 49:4.0240]

Current through Register Vol. 50, No. 6, June 20, 2024
A. The name of a substance or derivative
				required to be borne on the label of a drug by regulation
				§1163 or
				R.S.
				40:617 (A) (5) and regulations promulgated
				thereunder shall be the common or usual name of such substance or derivative,
				unless it is designated solely by a name recognized in an official compendium
				and such designation complies with the provisions of
				R.S.
				40:617 (A) (4).
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1153 - Names of Narcotic and Hypnotic Substances [Formerly 49:4.0250]

Current through Register Vol. 50, No. 6, June 20, 2024
A. A statement on
				the label of a drug listing as an ingredient a product which is a chemical
				derivative of a substance named in
				R.S.
				40:617 (A) (5), shall show the name of the
				substance from which the ingredient is derived and shall state that the
				ingredient is a derivative thereof.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1155 - Quantity Expression, Unit Form [Formerly 49:4.0270]

Current through Register Vol. 50, No. 6, June 20, 2024
A. If the drug is in tablet, capsule, ampoule
				or other unit form, the statement of the quantity or proportion of the
				substance or derivative contained therein shall express the weight or measure
				of the substance or derivative in each such unit. If the drug is not in such
				unit form, the statement shall express the weight or measure of the substance
				or derivative in a specified unit of weight or measure of the drug. The
				statement shall be in terms which are informative to the ordinary consumer and
				user of the drug.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Tit le 40,
				  as amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1157 - Habit Forming Drugs, Labeling and Warning Statement [Formerly 49:4.0280]

Current through Register Vol. 50, No. 6, June 20, 2024
A. The names and
				quantities or proportions of all such substances and derivatives, and the
				statement: "Warning-May Be Habit Forming", shall immediately precede or
				immediately follow (without intervening written, printed or graphic matter) the
				name by which such drug is titled in the part or panel of the label thereof
				which is presented or displayed under customary conditions of
				purchase.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1159 - Habit Forming Drugs, Prescription Required Department [Formerly 49:4.029]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Drugs designated
				by the Louisiana department as habit forming or dangerous, shall only be sold
				or dispensed on the original prescription of a physician, dentist or
				veterinarian. The refilling of such a prescription for any habit forming or
				dangerous drug, except upon authorization of the original prescriber, is hereby
				prohibited. Any drug, the label of which bears the caution legend sold or
				dispensed on the prescription of a physician, dentist or veterinarian and such
				prescription shall not be refilled except upon the authorization of the
				original prescriber. For the purpose of these regulations a prescription is
				hereby defined as: A written direction for the preparation and administration
				of a drug, signed by a legally authorized physician, dentist or veterinarian.
B. It shall be a violation of
				these regulations for any person other than a duly authorized physician,
				dentist or veterinarian, to prepare, issue, or offer to any other person a
				written direction for the preparation and administration of a dangerous or
				habit forming drug or any drug, the label of which bears the caution legend
				that such drug is to be sold only on a prescription.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1161 - Habit Forming Drugs, Labeling Exemptions [Formerly 49:4.0300]

Current through Register Vol. 50, No. 6, June 20, 2024
A. A drug shall not
				be considered to be misbranded by reason of failure of its label to bear the
				statement "Warning-May Be Habit Forming-"
1.
				If such drug is not suitable for internal use, and is distributed and sold
				exclusively for such external use as involves no possibility of habit
				formation; or
2. If the only
				substance or derivative subject to
				R.S.
				40:617 (A)(5) contained in such drug is
				chlorobutanol, which is present solely as a preservative and in a quantity not
				more than 0.5 percent by weight, and such drug is for parenteral use only;
				or
3. If the only substance or
				derivative subject to
				R.S.
				40:617 (A)(5) contained in such drug is
				chlorobutanol, which is present as an analgesic or as an analgesic and a
				preservative in a quantity not more than 3.0 percent, and such drug contains
				one or more other active ingredients and is for parenteral use only.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1163 - Misbranding, Ingredients Designation [Formerly 49:4.0310]

Current through Register Vol. 50, No. 6, June 20, 2024
A. A drug shall be deemed to be misbranded if
				it 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 made from two or more
				ingredients, the common or usual name of each active ingredient, including the
				quantity, kind and proportion of any alcohol, ana 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 glycosides, mercury,
				ouabain, strophanth in, 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 2 of this Subsection is
				impracticable, exemptions shall be as provided by
				§1186
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1165 - Prescription Drugs List [Formerly 49:4.0320]

Current through Register Vol. 50, No. 6, June 20, 2024
A. The following drugs in therapeutically
				effective proportions are considered dangerous for use otherwise than on the
				prescription of a duly qualified physician, dentist, or veterinarian licensed
				by law to administer drugs:
1. Acetanilid
				(where dosage provides a total daily intake of more than 5 grains or more than
				2 1/2 grains during any 3 hour period);
2. Acetophenetidln (where daily dosage
				provides more than 15 grains);
3.
				Aconite (for internal use);
4.
				Aminopyrine;
5. Antipyrine (where
				daily dosage provides more than 15 grains);
6. Barbiturate;
7. Benzedrine sulphate (for internal
				use);
8. Bromides (where dosage
				involves consumption of more than 30 grains per day or more than 15 grains
				during any 3 hour period;
9.
				Bromide-Acetanilid combinations (where dosage provides more than a total daily
				dose of 15 grains of sodium bromide and 5 grains of acetanilid or more than 7
				1/2 grains of sodium bromide and 2 1/2 grains of acetanilid during any 3 hour
				period. Comparable amounts of other bromide preparations are subject to the
				same restrictions);
10. Cantharides
				(for internal use);
11. Causaline
				Sedormide;
12. Chrysarobin or goa
				powder
13. Chrysophanic
				acid;
14. Cincophen, Neocincopene
				and other cincophen derivatives;
15. Colchicine;
16. Colchicum;
17. Digitalis;
18. Emetine;
19. Epinephrine (in solution of 1 percent or
				stronger);
20. Ipecac (in daily
				dosage greater than 10 grains)
21.
				Phosphides;
22.
				Phosphorus;
23. Radium and
				radio-active drugs;
24.
				Squill;
25. Strophanthus;
26. Strychnine (in daily dosage greater than
				1/20 grain);
27.
				Sulfanilamide;
28. Sulfapyradine
				and other related "sulfa" drugs;
29. Sulfathiazole (for internal
				use);
30. Tansy, Tansy
				Oil;
31. Thiocyanates;
32. Thyroid;
33. the "anthelmintic" drugs:
a. carbon tetrachloride;
b. tetrachlorethylene;
c. male fern (aspidium);
d. santonin;
e. wormseed oil (chenopodiurn oil);
f. thymol.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1167 - Dispense Defined [Formerly 49:4.0330]

Current through Register Vol. 50, No. 6, June 20, 2024
A. The term "dispense" as used in 4.0701
				shall mean the use of a drug as an ingredient in the corn pounding of any
				prescription issued by a physician, dentist, or veterinarian in his
				professional practice.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1169 - Physician, Dentist and Veterinarian, Must be Licensed [Formerly 49:4.0340]

Current through Register Vol. 50, No. 6, June 20, 2024
A. The terms
				"physician", "dentist", and "veterinarian", as used in relation to the
				exemption from any labeling requirement of any drug or device shall include
				only those physicians, dentists or veterinarians who are licensed by law to
				administer or apply such drug or device.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1171 - Specific Names Required [Formerly 49:4.0350]

Current through Register Vol. 50, No. 6, June 20, 2024
A. The name of an ingredient, substance,
				derivative, or preparation required by
				§1163 to be borne on the label of a drug
				shall be the name thereof which is listed in § 1163, or if not so listed, shall
				be a specific name and not a collective name. Where an ingredient is an article
				the name of which is recognized in an official compendium and such article
				complies with the specifications set forth for such an article in the
				compendium, the ingredient may be designated on the label of the drug by the
				common or usual name in the compendium.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1173 - Quantities Required [Formerly 49:4.0360]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Where a component of a drug contains a
				substance the quantity or proportion of which is required by
				§1163. A.2 to appear on the label and the
				component is not a derivative or preparation of that substance, as defined in
				§1171, the label shall bear in conjunction with the name of the component, a
				statement of the quantity or proportion in the drug of the substance required
				by §1163. A.2 to appear
				on the label.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1175 - Abbreviations and Chemical Formulas, Not Common or Usual Names [Formerly 49:4.0370]

Current through Register Vol. 50, No. 6, June 20, 2024
A. An
				abbreviation or chemical formula shall not be considered to be a common or
				usual name. The name "acetophenetidin" shall be considered to be the same as
				the name "acetphenetidin"; "amino pyrine" the same as "amidopyrine". The name
				"alcohol", without qualification shall mean "ethyl alcohol".
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1177 - Misbranding, Ingredients, Derivatives Designation [Formerly 49:4.0380]

Current through Register Vol. 50, No. 6, June 20, 2024
A. A derivative or
				preparation of a substance named in
				§1163. A.2 is an article which is derived
				or prepared from such substance by any method.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1179 - Misbranding, Ingredients, or Derivatives [Formerly 49:4.0390]

Current through Register Vol. 50, No. 6, June 20, 2024
A. A statement on
				the label of a drug or the name of an ingredient thereof, which ingredient is a
				derivative or preparation of a substance named
				§1163. A 2, shall show the substance from
				which the ingredient is derived or prepared and shall also show that the
				ingredient is a derivative or preparation thereof.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1181 - Labeling, Weight or Measure of a Drug [Formerly 49:4.0400]

Current through Register Vol. 50, No. 6, June 20, 2024
A. If the drug is
				in tablet, capsule, ampoule, or other unit form, the statement of the quantity
				or proportion of a substance, derivative, or preparation contained therein
				shall express the weight or measure of the substance, derivative or preparation
				in each unit. If the drug is not in unit form, the statement shall express the
				weight or measure of the substance, derivative, or preparation in a specified
				unit of weight or measure of the drug, or the proportion in the drug. Such a
				statement shall be in terms which are informative to the ordinary consumer and
				user of the drug.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1182 - Alcohol and Other Ingredient Labeling [Formerly 49:4.0410]

Current through Register Vol. 50, No. 6, June 20, 2024
A. A statement of the proportion of alcohol
				present shall express the percentage of absolute alcohol by volume at 60
				degrees Fahrenheit (15.56 degrees Centigrade). A statement of the proportion
				present of any substance, derivative, or preparation other than alcohol shall
				express the proportion by weight, except that, if both the substance,
				derivative, or preparation and the drug containing it are liquid, the statement
				may express the proportion present by volume at 68 degrees Fahrenheit (20
				degrees Centigrade), but in such case the statement shall be so qualified as to
				show definitely that the proportion is expressed by volume.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1183 - Statement of Quantity or Proportion of a Derivative or Preparation [Formerly 49:4.0420]

Current through Register Vol. 50, No. 6, June 20, 2024
A. In
				case a statement of the quantity or proportion of a derivative or preparation
				in a drug is not as informative to consumers or users of the drug regarding the
				activity or consequence of use thereof as would be a statement of the quantity
				or proportion of the substance from which the derivative or preparation is
				derived or prepared, than the quantity or proportion of such substance shall
				also be stated on the label of the drug.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1184 - Misleading Labeling [Formerly 49:4.0430]

Current through Register Vol. 50, No. 6, June 20, 2024
A. A label of a drug may be deemed to be
				misleading by reason (among other reasons) if:
1. The order in which the names of
				ingredients, substances, derivatives, or preparations appear thereon, or the
				relative prominence otherwise given the names; or
2. Its failure to reveal the proportion of,
				or other fact with respect to, an ingredient, substance, derivative, or
				preparation, when such a proportion or other fact is material in the light of
				the representation that the ingredient, substance, derivative, or preparation
				is a constituent of the drug.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1185 - Labeling-Exemption from Requirements, Conditions or Exemption [Formerly 49:4.0440]

Current through Register Vol. 50, No. 6, June 20, 2024
A. The label of a
				drug shall be exempt from compliance with the requirements of
				§1163. A.2 if the container is so small
				that the label when extended over the area available for label space is of
				insufficient size so that all words, statements, and other information required
				by or under authority of the Act to appear on the label of such drug, cannot be
				so placed on the label as to comply with the requirements of
				R.S.
				40:617 (A)(4) and regulations
				§1143 and its subparagraphs promulgated
				thereunder. This exemption shall be on the condition that if the statement on
				the label of the quantity of the contents is omitted as authorized by
				§1141 under
				R.S.
				40:617 (A)(3) and this omission will allow
				sufficient space to include the information required by
				§1163. A.2 even though the statement is
				not so conspicuous as to render it likely to be read by the ordinary individual
				under customary conditions of purchase, then the statement of the quantity of
				contents shall be omitted and the information required by 4.07 (2) shall be
				stated as prominently as is practicable.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1186 - Labeling-Exempting of Certain [Formerly 49:4.0450]

Current through Register Vol. 50, No. 6, June 20, 2024
A. A drug shall be exempt from the
				requirements of
				§1163. A.2 with respect to the alkaloids,
				atropine, hyoscine or hyoscyamine, contained in the drug, if the alkaloid is
				contained therein as constituent of belladonna, hyoscyamus, scopola,
				stramonium, or other plant material, or any preparation thereof, which was used
				as an ingredient of the drug, and no practical and accurate method of analysis
				exists for the quantitative determination of each such alkaloid in the
				ingredient. This exemption shall be on the condition that the label of the drug
				shall state the quantity or proportion of total alkaloids contained therein as
				constituents of the ingredient.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1187 - Drug Labeling-Directions, Warnings [Formerly 49:4.0460]

Current through Register Vol. 50, No. 6, June 20, 2024
A. The labeling of
				drugs or devices shall bear:
1. adequate
				directions for use; and
2. adequate
				warnings against misuse in connection with pathological conditions or by
				children where its use may be dangerous to health; or against unsafe dosage,
				methods, or duration of administration or application, in such manner and form
				as are necessary for the protection of users.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1188 - Labeling-Inadequate Directions [Formerly 49:4.0470]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Directions for use may be deemed to be
				inadequate by reason, (among other reasons) of omission in whole or in part, or
				incorrect specification of:
1. directions for
				use in all conditions for which the drug or device is prescribed, recommended,
				or suggested in its labeling, or in advertising regarding it which is
				disseminated or sponsored by, or on behalf of, its manufacturer or packer, or
				in such other conditions, if any there be, for which such drug or device is
				commonly and effectively used; or
2. quantity of dose (including quantities for
				persons of different ages and different physical conditions); or
3. frequency and duration of administration
				or application; or
4. time of
				administration or application (in relation to time of meals, time of onset of
				symptoms, or other time factor); or
5. route or method of administration or
				application; or
6. preparation for
				use (shaking, dilution, adjustment of temperature, or other manipulation or
				process).
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1189 - Labeling of Drugs or Devices-Exemptions from Requirements [Formerly 49:4.0480]

Current through Register Vol. 50, No. 6, June 20, 2024
A. A
				shipment or other delivery of a drug or device shall be exempt from the
				requirements of
				§1187 A. 1, if it complies with all of the
				following conditions.
1. Such drug or device,
				because of its toxicity or other potentiality for harmful effect or the method
				of its use or the collateral measures necessary to its use or the collateral
				measures necessary to its use, is generally recognized by experts qualified by
				scientific training and experience to evaluate its safety and efficacy, as not
				safe and not efficacious for use except by or under the supervision of a
				physician, dentist, or veterinarian.
2. Such shipment or delivery is made for the
				purpose of exclusive use:
a. by physicians,
				dentists, or veterinarians in their professional practice; or
b. upon their prescriptions and under
				labeling bearing the directions for use specified in such prescriptions;
				or
c. in the manufacture of another
				drug or device.
3.
				Adequate directions for the use of such drug or device by physicians, dentists,
				or veterinarians, as the case may be, are readily available.
4. The label of such drug or device (other
				than surgical instruments and other devices to be used exclusively by
				physicians, dentists, or veterinarians in their professional practice) bears
				the statements: "Caution-To be dispensed only by a ..", the blank being filled
				in with one or more of the words "physician", "dentist", and "veterinarian", as
				the case may be.
5. No
				representation with respect to the conditions for which a drug or device is to
				be used and no statement of dosage or other direction for use appears in its
				labeling except representations or directions:
a. in printed matter supplied to a physician,
				dentist or veterinarian separately from such drug or device; and
b. specified in the prescription of a
				physician, dentist, or veterinarian upon which such drug or device was
				dispensed.
6. In the
				case of a drug which is not designated solely by a name recognized in an
				official compendium and which is fabricated from two or more ingredients, its
				label also bears a statement of the quantity or proportion of each active
				ingredient.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1190 - Labeling Exemptions [Formerly 49:4.0490 Labeling Exemptions]

Current through Register Vol. 50, No. 6, June 20, 2024
A. A shipment or
				other delivery of a drug or device shall also be exempt from the requirements
				of §1187. A. 1 if it
				complies with all the conditions set forth in paragraph
				§1189. A.3 and
				§1189. A 6, and if such shipment or
				delivery is made to a physician, dentist, veterinarian, hospital, or clinic for
				the purpose of exclusive use by physicians, dentists, or veterinarians in their
				professional practice.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1191 - Labeling Exemptions, for Manufacturing Use Only [Formerly 49:4.0500]

Current through Register Vol. 50, No. 6, June 20, 2024
A. A shipment or
				other delivery of a drug or device shall also be exempt from the requirements
				of §1187. A 1, if it
				is made to a dealer or manufacturer for the purpose of exclusive use in the
				manufacture of another drug or device and its label bears the statement: For
				manufacturing use only".
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1192 - Labeling Exemptions [Formerly 49:4.0510]

Current through Register Vol. 50, No. 6, June 20, 2024
A. A shipment or other delivery of a drug or
				device shall also be exempt from the requirements of
				§1187. A. 1 with respect to common uses,
				adequate directions for which are known by the ordinary individual.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1193 - Labeling Exemptions Void [Formerly 49:4.0520]

Current through Register Vol. 50, No. 6, June 20, 2024
A. No exemption under any provision of these
				regulations shall apply to any shipment or other delivery of:
1. a drug if the advertising disseminated or
				sponsored by or on behalf of its manufacturer, packer, or other person
responsible for making such shipment or delivery, contains
				  any representation not borne by its labeling;
2. a drug intended for administration by
				iontophoresis or by injection into or through the skin or mucous
				membrane;
3. a drug or device if
				such shipment or delivery is made in the course of the conduct of a business or
				dispensing drugs or devices by mail order or dispensed pursuant to diagnosis by
				mail.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1194 - Expiration of Labeling Exemption [Formerly 49:4.0530]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Any exemption of a drug or device under
				§1189, § 1190, or
				§
										1191 immediately expire if the
				drug or device, or any part thereof, is disposed of for any purpose other than
				the exclusive use specified. Any person responsible for such an expiration of
				exemption shall be considered as having caused an act of misbranding for which
				such person shall be liable, unless, prior to such disposition, the drug or
				device is relabeled to comply with the requirements of
				§1187. A. 1 of these
				regulations.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1195 - Labeling Exemption, Drugs to be Processed, Labeled or Repackaed [Formerly 49:4.0540]

Current through Register Vol. 50, No. 6, June 20, 2024
A. A
				drug or device which is to be processed, labeled or repacked, in substantial
				quantities in accordance with regular trade practice, at an establishment other
				than were originally processed or packed, shall be exempt, except as provided
				by §1196 and §1197, from
				compliance with the labeling and packaging requirements of
				R.S.
				40:616 (5)
				R.S.
				40:617 (A) (3), (5), (6) and (7) and
				§1187 of these regulations, during transit
				from the original establishment to the labeling, processing, or repacking
				plant, and the time of holding in such establishment if:
1. the person responsible for the transit of
				the drug or device in commerce is the operator of the establishment where the
				drug or device is to be processed, labeled or repacked; or
2. in case such person is not the operator,
				the shipment or delivery of the drug or device is made under a written
				agreement, signed by and containing the post office addresses of the person
				responsible for the shipment or delivery and the operator of the processing,
				labeling or repacking plant, and also containing specifications for the
				processing, labeling, or repacking, as the case may be, of the drug or device,
				which if followed will ensure that the drug or device will not be adulterated
				or misbranded within the meaning of the Act upon completion of the processing,
				labeling, or repacking. Each party to the agreement shall keep a copy of the
				agreement until all the shipment or delivery subject to its terms have been
				removed from the processing, labeling, or repacking plant; and provided that
				copies of the agreement shall be made available for inspection at any
				reasonable hour by any officer or agent of the department who requests them.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1196 - Voiding of Exemption under Clause [Formerly 49:4.0550]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Any exemption of a drug or device under
				§
										1195. A. 1 shall immediately
				become void if the drug or device, or any part thereof, at time of removal from
				the original establishment is adulterated or misbranded within the meaning of
				the Act when so removed.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1197 - Voiding of Exemption Under Clause (2) of 4.0540 [Formerly 49:4.0560]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Any exemption of
				a drug or device under
				§1195. A.2 shall immediately become void:
1. Upon refusal by tie person responsible for
				the shipment or delivery of the drug or device to make available for inspection
				a copy of the agreement specified in, and required
				§1195. A.2
2. Upon refusal by the operator of the
				establishment where the drug or device is to be abeled, processed, or repacked
				to make available for inspection a copy of the agreement specified in, and
				required by
				§1195. A.2
3. If the drug or device, or any part
				thereof, at time of removal from the original establishment is adulterated or
				misbranded within the meaning of the Act when so removed.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 11 - Drug Regulations › Section I-1198 - Harmless Animal or Vegetable Dyes, Coal-Tar Colors, Use of [Formerly 49:4.057]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Only harmless
				animal or vegetable dyes and such coal-tar colors as have been certified by the
				Federal Food, Drug and Cosmetic Act of 1938 and defined under coal-tar color
				regulations as published by the Federal Security Agency in Service and
				Regulatory Announcements FDC 3, issued September, 1940, or as amended from time
				to time, shall be used in, offered for sale for use in, or distributed for use
				for purposes of coloring only in drugs, drug products, drug ingredients or
				their containers.
AUTHORITY NOTE:
				  Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
				  amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 12 - Seafood Regulations › Subchapter A - Shellfish Depuration Regulations › Section I-1200 - Definitions [Formerly 49:6.1000]

Current through Register Vol. 50, No. 6, June 20, 2024
Depuration
-a controlled process whereby
					 shellfish harvested from restricted or approved waters are held live for
					 purification in specially designed tanks for the primary purpose of reducing
					 the number of pathogenic organisms that may be present to levels that are
					 considered acceptable for human consumption without further thermal
					 processing.
On Shore Wet Storage
-a controlled process
					 whereby shellfish harvested from waters approved by the state health officer
					 for direct market harvesting are held live in specially designed tanks
					 primarily for the purpose of desanding and/or improving palatability by
					 increasing salt content.
AUTHORITY NOTE:
					 Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as
					 amended.
Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 12 - Seafood Regulations › Subchapter A - Shellfish Depuration Regulations › Section I-1201 - Permit Requirements [Formerly 49:6.1010]

Current through Register Vol. 50, No. 6, June 20, 2024
A. The controlled depuration of shellfish
				  (oysters, clams, and mussels) is prohibited, unless the operator of the
				  establishment has an unsuspended or unrevoked permit-to operate issued by the
				  Department of Health and Human Resources. Upon receipt of an application for a
				  permit-to operate, and successful completion of process verification studies,
				  an inspection will be made by a duly authorized representative of the state
				  health officer, and if the establishment is found properly equipped, in
				  accordance with regulations, a permit will be issued authorizing the owner or
				  operator of said establishment to engage in the business of operating either an
				  on shore wet storage plant or depurating plant. Plans and specifications shall
				  be submitted for review and approval prior to the construction of either type
				  of plant.
1. Such permit may be suspended or
				  revoked at any time for violation of these regulations. A suspended or revoked
				  permit may be reinstated or re-issued when the proper improvements have been
				  made.