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Chemical description of derivative

Common or official name of chemical

derivative or its salts

Some trade or other names of chemi

cal derivative or its salts 1

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Cyclobarbitone. Namuron. Palinum. Phanodorm. Phanodorn. Tetrahydro phenobarbital. Pentenal. Hebaral. Ortal Sodium. Amytal. Ipral. 844. Embutal. Nembutal. Napethal. Pentyl. Intraval Sodium. Nesdonal Sodium. Pentothal Sodium. Thiothal Sodium. Delvinal Sodium. Barbenyl. Barbiphenyl. Dormiral. Euneryl. Gardenal. Luminal. Nunol. Neurobarb. Phenonyl. Somonat. Mebaral. Phemitone. Prominai. Eldoral. Noctal. Nostal. Methioturiate. Neraval. Thiogenal. Rutonal.

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'This list of trade or other names is not a complete list of the many proprietary names under which the designated habit-forming chemical derivatives are distributed.

The name "butalbital" is obsolete for this compound; "butalbital” is the nonproprietary name assigned by the United States Adopted Name Council and the World Health Organization for 5-allyl-5-isobutylbarbituric acid.

Subpart B-Labeling

8 329.10 Labeling requirements for

habit-forming drugs. (a)(1) The name of a substance or derivative required to be borne on the label of a drug by section 502(d) of the act 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 section 502(c).

(2) A statement on the label of a drug of the name of a constituent, which constituent is a chemical derivative of a substance named in section 502(a) of the act, shall show the substance from which such constituent is derived and that such constituent is a derivative thereof.

(b) If the drug is in tablet, capsule, ampul, or other unit form, the statement of the quantity or proportion of such substance or derivative contained therein shall express the weight or measure of such 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 such substance or derivative in a specified unit of weight or measure of the drug. Such statement shall be in terms

which are informative to the ordinary consumer and user of the drug.

(c) The names and quantities or proportions of all such substances and derivatives, and the statement “Warning—May be habit forming”, shall 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.

(d) 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 section 502(d) of the act 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 ug is for parenteral use only; or

(3) If the only substance or derivative subject to section 502(d) of the act 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,

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§ 329.20 Exemption of certain habit

forming drugs from prescription re

quirements. The prescription-dispensing requirements of section 503(b)(1)(A) of the act are not necessary for the protection of the public health with respect to the following drugs subject to section 502(d):

(a) The following exempt narcotic preparations:

(1) Pharmaceutical preparations containing not more than 100 milligrams of opium per 100 milliliters or per 100 grams.

(2) Pharmaceutical preparations containing not more than 16.2 milligrams (1/4 grain) morphine, or any of its salts, per 29.5729 cubic centimeters (1 fluid ounce) or per 28.3 grams (1 avoirdupois ounce);

(3) Pharmaceutical preparations containing not more than 64.8 milligrams (1 grain) codeine, or any of its salts, per 29.5729 cubic centimeters (1 fluid ounce) or per 28.3 grams (1 avoirdupois ounce);

(4) Pharmaceutical preparations containing not more than 32.4 milligrams (1/2 grain) dihydrocodeine, or any of its salts, per 29.5729 cubic centimeters (1 fluid ounce) or per 28.3 grams (1 avoirdupois ounce);

(5) Pharmaceutical preparations containing not more than 16.2 milligrams (1/4 grain) ethylmorphine, or any of its salts, per 29.5729 cubic centimeters (1 fluid ounce) or per 28.3 grams (1 avoirdupois ounce); Provided, That the preparations described in this paragraph contain one or more nonnarcotic active medicinal ingredients in sufficient proportion to confer upon the preparation valuable medicinal qualities other than those possessed by the narcotic drug alone.

330.10 Procedures for classifying OTC drugs

as generally recognized as safe and effective and not misbranded, and for estab

lishing monographs. 330.11 NDA deviations from applicable

monograph 330.12 Status of over-the-counter (OTC)

drugs previously reviewed under the

Drug Efficacy Study (DESI). 330.13 Conditions for marketing ingredients

recommended for over-the-counter (OTC)

use under the OTC drug review. AUTHORITY: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.

SOURCE: 39 FR 11741, Mar. 29, 1974, unless otherwise noted.

Subpart A-General Provisions

$330.1 General conditions for general

recognition as safe, effective and

not misbranded. An over-the-counter (OTC) drug listed in this subchapter is generally recognized as safe and effective and is not misbranded if it meets each of the conditions contained in this part and each of the conditions contained in any applicable monograph. Any product which fails to conform to each of the conditions contained in this part and in an applicable monograph is liable to regulatory action.

(a) The product is manufactured in compliance with current good manufacturing practices, as established by parts 210 and 211 of this chapter.

(b) The establishment(s) in which the drug product is manufactured is registered, and the drug product is listed, in compliance with part 207 of this chapter. It is requested but not required that the number assigned to the product pursuant to part 207 of this chapter appear on all drug labels and in all drug labeling. If this number is used, it shall be placed in the manner set forth in part 207 of this chapter.

(c)(1) The product is labeled in compliance with chapter V of the act and subchapter C et seq. of this chapter. For purposes of $201.61(b) of this chapter, the statement of identity of the product shall be the term or phrase used in the applicable monograph established in this part.

(2)(i) The label and labeling of the product contain in a prominent and conspicuous location the labeling describing the “Indications” that have been established in an applicable final monograph. At the option of the manufacturer, this labeling may be designated “APPROVED USES," or be given a similar designation as permitted by this paragraph, each time it appears in the labeling, e.g., on the outer carton, inner bottle label, and on any package insert or display material. If the “APPROVED USES" or a similar designation is used, the labeling involved shall appear within a boxed area. Other applicable labeling established under this subchapter and subchapter of this chapter may be included in the boxed area. If such other labeling is included, the boxed area shall be designated "APPROVED INFORMATION" rather than APPROVED USES." The "indications" information appearing in the boxed area shall be stated in the exact language of the monograph. Other information within the boxed area also shall be stated in exact language where exact language has been established and identified by quotation marks in an applicable monograph or by regulation (e.g., $201.63 of this chapter). A statement that the information in the box

was published by the Food and Drug Administration" shall appear within the boxed area, or reasonably close by. In lieu of such statement, the designation of the boxed area may be modified to read: “FDA APPROVED USES" or “FDA APPROVED INFORMATION, " as appropriate, or “USES (or “INFORMATION") APPROVED BY THE FOOD AND DRUG ADMINISTRATION," or other similar wording.

(ii) At the option of the manufacturer, as an alternative to the requirements of paragraph (c)(2)(i) of this section, the label and labeling of the product may contain in a prominent and conspicuous location other truthful and nonmisleading statements describing only those indications for use that have been established in an applicable monograph, subject to the provisions of section 502 of the act relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act. Such labeling shall not be boxed and shall not contain the statements provided in paragraph (c)(2)(1) of this section relating to “APPROVED USES," or "APPROVED INFORMATION," or contain a statement that the labeling has been published by the Food and Drug Administration.

(iii) At the option of the manufacturer, the label and labeling may meet the boxed-area requirements of paragraph (C)(2)(i) of this section and, in addition, other truthful and nonmisleading statements describing only those indications for use that have been established in an applicable monograph may appear elsewhere in the labeling, that is, outside the boxed area, subject to the provisions of section 502 of the act relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(iv) At the option of the manufacturer, more than one of the alternatives described in paragraphs (c)(2)(i), (ii), and (iii) may be used in separate labeling, e.g., container label, outer carton, package insert, display material, for a particular OTC drug

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