Page:United States Statutes at Large Volume 104 Part 6.djvu/463

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PUBLIC LAW 101-647—NOV. 29, 1990 104 STAT. 4853 SEC. 1903. REGULATIONS BY ATTORNEY GENERAL. 21 USC 802 note. (a) ABUSE POTENTIAL.— The Attorney General, upon the recommendation of the Secretary of Health and Human Services, may, by regulation, exempt any compound, mixture, or preparation containing a substance in paragraph (41) of section 102 of the Controlled Substances Act (as added by section 2 of this Act) from the application of all or any part of the Controlled Substances Act if, because of its concentration, preparation, mixture or delivery y- system, it has no significant potential for abuse. (b) DRUGS FOR TREATMENT OF RARE DISEASES. —I f the Attorney General finds that a drug listed in paragraph (41) of section 102 of the Controlled Substances Act (as added by section 2 of this Act) is— (1) approved by the Food and Drug Administration as an accepted treatment for a rare disease or condition, as defined in section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb); and (2) does not have a significant potential for abuse, the Attorney General may exempt such drug from any production regulations otherwise issued under the Controlled Substances Act as may be necessary to ensure adequate supplies of such drug for medical purposes. (c) DATE OF ISSUANCE OF REGULATIONS. —The Attorney General shall issue regulations implementing this section not later than 45 days after the date of enactment of this Act, except that the regulations required under section 3(a) shall be issued not later than \ 180 days after the date of enactment of this Act. SEC. 1904. AMENDMENT TO THE FOOD, DRUG, AND COSMETIC ACT. Section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amended by inserting a new subsection (e) as follows: "(e)(1) Except as provided in paragraph (2), whoever knowingly distributes, or possesses with intent to distribute, human growth hormone for any use in humans other than the treatment of a disease or other recognized medical condition, where such use has been authorized by the Secretary of Health and Human Services under section 505 and pursuant to the order of a physician, is guilty of an offense punishable by not more than 5 years in prison, such fines as are authorized by title 18, United States Code, or both. "(2) Whoever commits any offense set forth in paragraph (1) and such offense involves an individual under 18 years of age is punishable by not more than 10 years imprisonment, such fines as are authorized by title 18, United States Code, or both. "(3) Any conviction for a violation of paragraphs (1) and (2) of this subsection shall be considered a felony violation of the Controlled Substances Act for the purposes of forfeiture under section 413 of such Act. "(4) As used in this subsection the term 'human growth hormone' means somatrem, somatropin, or an anedogue of either of them. "(5) The Drug Enforcement Administration is authorized to investigate offenses punishable by this subsection.". SEC. 1905. CONVICTION FOR VIOLATION OF SECTION 303(e) OF THE FED- ERAL FOOD, DRUG, AND COSMETIC ACT. Section 2401 of the Anti-Drug Abuse Act of 1988 (Public Law Repeal. 100-690; 102 Stat. 4181) is repealed. 21 USC 333a.