Food and Drug Administration, HHS § 329.10
Chemical description of derivative Common or official name of chemical Some trade or other names of chem- derivative or its salts ical derivative or its salts 1
PARENT SUBSTANCEÐCODEINE
Codeine methylbromide ...... Eucodin. Dihydrocodeinone ...... Dicodid. Dihydrohydroxycodeinone ...... Eucodal ...... Oxycodone hydrochloride. 14-hydroxydihydrocodeinone. All salts of the foregoing chemical derivatives of codeine obtained by combining any such de- rivative of codeine with any acid.
PARENT SUBSTANCEÐHEROIN
All salts of heroin obtained by combining heroin with any acid.
PARENT SUBSTANCEÐMORPHINE
Dihydromorphine ...... Paramorphan. Dihydromorphinone ...... Dihydromorphinone hydrochloride ...... Dilaudid. Dimorphone. Dihydromorphinonium chloride ...... Hydromorphone hydrochloride. Ethylmorphine ...... Ethylmorphine hydrochloride ...... Dionin. Ethylmorphinium chloride.. All salts of the foregoing chemical derivatives of morphine and all salts of morphine obtained by combining any such derivative or mor- phine with any acid.
PARENT SUBSTANCEÐOPIUM
Extract of opium. Fluidextract of opium. Camphorated opium tincture. Deodorized opium tincture. Laudanum. Opium tincture. Paregoric. Tincture of opium.
PARENT SUBSTANCEÐPARALDEHYDE
Metaldehyde.
PARENT SUBSTANCEÐSULFONMETHANE
2,2-Diethylsulfonylbutane ...... Sulfonethylmethane ...... Diethylsulfonmethylethyl-methane. Ethylsulfonal. 2,2-bis-(Ethylsulfonyl)-butane. Methylsufonal. Sulfonethlylmethanum. Trional. 3,3-Diethylsulfonylpentane ...... Sulfondiethylmethane. 1 This list of trade or other names is not a complete list of the many proprietary names under which the designated habit-form- ing chemical derivatives are distributed. 2 The name ``butalbital'' is obsolete for this compound; ``butalbital'' is the nonproprietary name assigned by the United States Adopted Name Council and the World Health Organization for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 of such substance or derivative, unless it is designated solely by a name recog- § 329.10 Labeling requirements for nized in an official compendium and habit-forming drugs. such designation complies with the (a)(1) The name of a substance or de- provisions of section 502(c). (2) A statement on the label of a drug rivative required to be borne on the of the name of a constituent, which label of a drug by section 502(d) of the constituent is a chemical derivative of act shall be the common or usual name a substance named in section 502(d) of
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the act, shall show the substance from Subpart C—Exemptions which such constituent is derived and that such constituent is a derivative § 329.20 Exemption of certain habit- thereof. forming drugs from prescription re- (b) If the drug is in tablet, capsule, quirements. ampul, or other unit form, the state- The prescription-dispensing require- ment of the quantity or proportion of ments of section 503(b)(1)(A) of the act such substance or derivative contained are not necessary for the protection of therein shall express the weight or the public health with respect to the measure of such substance or deriva- following drugs subject to section tive in each such unit. If the drug is 502(d): not in such unit form the statement (a) The following exempt narcotic shall express the weight or measure of preparations: such substance or derivative in a speci- (1) Pharmaceutical preparations con- fied unit of weight or measure of the taining not more than 100 milligrams drug. Such statement shall be in terms of opium per 100 milliliters or per 100 which are informative to the ordinary grams. consumer and user of the drug. (2) Pharmaceutical preparations con- (c) The names and quantities or pro- taining not more than 16.2 milligrams portions of all such substances and de- (1⁄4 grain) morphine, or any of its salts, rivatives, and the statement ‘‘Warn- per 29.5729 cubic centimeters (1 fluid ing—May be habit forming’’, shall im- ounce) or per 28.3 grams (1 avoirdupois mediately follow (without intervening ounce); written, printed, or graphic matter) (3) Pharmaceutical preparations con- the name by which such drug is titled taining not more than 64.8 milligrams in the part or panel of the label thereof (1 grain) codeine, or any of its salts, which is presented or displayed under per 29.5729 cubic centimeters (1 fluid customary conditions of purchase. ounce) or per 28.3 grams (1 avoirdupois (d) A drug shall not be considered to ounce); be misbranded by reason of failure of (4) Pharmaceutical preparations con- its label to bear the statement ‘‘Warn- taining not more than 32.4 milligrams ing—May be habit forming’’: (1⁄2 grain) dihydrocodeine, or any of its (1) If such drug is not suitable for in- salts, per 29.5729 cubic centimeters (1 ternal use, and is distributed and sold fluid ounce) or per 28.3 grams (1 avoir- exclusively for such external use as in- dupois ounce); volves no possibility of habit forma- (5) Pharmaceutical preparations con- tion; or taining not more than 16.2 milligrams (2) If the only substance or derivative (1⁄4 grain) ethylmorphine, or any of its subject to section 502(d) of the act con- salts, per 29.5729 cubic centimeters (1 tained in such drug is chlorobutanol, fluid ounce) or per 28.3 grams (1 avoir- which is present solely as a preserva- dupois ounce); tive and in a quantity not more than Provided, That the preparations de- 0.5 percent by weight, and such drug is scribed in this paragraph contain one for parenteral use only; or or more nonnarcotic active medicinal (3) If the only substance or derivative ingredients in sufficient proportion to subject to section 502(d) of the act con- confer upon the preparation valuable tained in such drug is chlorobutanol medicinal qualities other than those which is present as an analgesic or as possessed by the narcotic drug alone. an analgesic and a preservative in a (b) Drugs containing chlorobutanol, quantity not more than 3.0 percent, intended for external use only. and such drug contains one or more (c) Epinephrine solution, 1 percent, other active ingredients and is for par- preserved with chlorobutanol and in- enteral use only. tended for use solely as a spray. CROSS REFERENCE: For the Spanish-lan- (d) Combination drugs listed in part guage version of the required labeling state- 329 as exempted from section 511 of the ment, see § 201.16(b) of this chapter. act. [39 FR 11736, Mar. 29, 1974, as amended at 40 [39 FR 11736, Mar. 29, 1974, as amended at 55 FR 13496, Mar. 27, 1975] FR 11581, Mar. 29, 1990]
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