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Ken is a NJ trial attorney who has published 130 articles in national and New Jersey publications on litigation topics. He has been selected to write the new ABA book: DUI and Drug Possession Defense".

Thursday, March 08, 2018

TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... Sec. 306

TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... Sec. 306 
(ii) is exempt from the provisions of section 505 of such Act relating to new drugs because— 
(I) it is intended solely for investigational use as described in section 505(i) of such Act; and 
(II) such product is being used exclusively for pur- poses of a clinical trial that is the subject of an effec- tive investigational new drug application. 
QUOTAS APPLICABLE TO CERTAIN SUBSTANCES 
SEC. 306. ΓΈ21 U.S.C. 826¿ (a) The Attorney General shall de- termine the total quantity and establish production quotas for each basic class of controlled substance in schedules I and II and for ephedrine, pseudoephedrine, and phenylpropanolamine to be manu- factured each calendar year to provide for the estimated medical, scientific, research, and industrial needs of the United States, for lawful export requirements, and for the establishment and mainte- nance of reserve stocks. Production quotas shall be established in terms of quantities of each basic class of controlled substance and not in terms of individual pharmaceutical dosage forms prepared from or containing such a controlled substance. 
(b) The Attorney General shall limit or reduce individual pro- duction quotas to the extent necessary to prevent the aggregate of individual quotas from exceeding the amount determined necessary each year by the Attorney General under subsection (a). The quota of each registered manufacturer for each basic class of controlled substance in schedule I or II or for ephedrine, pseudoephedrine, or phenylpropanolamine shall be revised in the same proportion as the limitation or reduction of the aggregate of the quotas. However, if any registrant, before the issuance of a limitation or reduction in quota, has manufactured in excess of his revised quota, the amount of the excess shall be subtracted from his quota for the fol- lowing year. 
(c) On or before October 1 of each year, upon application there- for by a registered manufacturer, the Attorney General shall fix a manufacturing quota for the basic classes of controlled substances in schedules I and II and for ephedrine, pseudoephedrine, and phenylpropanolamine that the manufacturer seeks to produce. The quota shall be subject to the provisions of subsections (a) and (b) of this section. In fixing such quotas, the Attorney General shall determine the manufacturer’s estimated disposal, inventory, and other requirements for the calendar year; and, in making his deter- mination, the Attorney General shall consider the manufacturer’s current rate of disposal, the trend of the national disposal rate dur- ing the preceding calendar year, the manufacturer’s production cycle and inventory position, the economic availability of raw mate- rials, yield and stability problems, emergencies such as strikes and fires, and other factors. 
(d) The Attorney General shall, upon application and subject to the provisions of subsections (a) and (b) of this section, fix a quota for a basic class of controlled substance in schedule I or II for any registrant who has not manufactured that basic class of controlled substance or ephedrine, pseudoephedrine, or phenylpropanolamine during one or more preceding calendar years. In fixing such quota, 
January 16, 2018 As Amended Through P.L. 115-91, Enacted December 12, 2017 
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January 16, 2018 
Sec. 306 TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... 56 
the Attorney General shall take into account the registrant’s rea- sonably anticipated requirements for the current year; and, in mak- ing his determination of such requirements, he shall consider such factors specified in subsection (c) of this section as may be relevant. 
(e) At any time during the year any registrant who has applied for or received a manufacturing quota for a basic class of controlled substance in schedule I or II or for ephedrine, pseudoephedrine, or phenylpropanolamine may apply for an increase in that quota to meet his estimated disposal, inventory, and other requirements during the remainder of that year. In passing upon the application the Attorney General shall take into consideration any occurrences since the filing of the registrant’s initial quota application that may require an increased manufacturing rate by the registrant during the balance of the year. In passing upon the application the Attor- ney General may also take into account the amount, if any, by which the determination of the Attorney General under subsection (a) of this section exceeds the aggregate of the quotas of all reg- istrants under this section. 
(f) Notwithstanding any other provisions of this title, no reg- istration or quota may be required for the manufacture of such quantities of controlled substances in schedules I and II or ephed- rine, pseudoephedrine, or phenylpropanolamine as incidentally and necessarily result from the manufacturing process used for the manufacture of a controlled substance or of ephedrine, pseudoephedrine, or phenylpropanolamine with respect to which its manufacturer is duly registered under this title. The Attorney Gen- eral may, by regulation, prescribe restrictions on the retention and disposal of such incidentally produced substances or chemicals. 
(g) Each reference in this section to ephedrine, pseudoephedrine, or phenylpropanolamine includes each of the salts, optical isomers, and salts of optical isomers of such chemical. 
(h)(1) Not later than 30 days after the receipt of a request de- scribed in paragraph (2), the Attorney General shall— 
(A) complete review of such request; and 
(B)(i) as necessary to address a shortage of a controlled substance, increase the aggregate and individual production quotas under this section applicable to such controlled sub- stance and any ingredient therein to the level requested; or 
(ii) if the Attorney General determines that the level re- quested is not necessary to address a shortage of a controlled substance, the Attorney General shall provide a written re- sponse detailing the basis for the Attorney General’s deter- mination. 
The Secretary shall make the written response provided under sub- paragraph (B)(ii) available to the public on the Internet Web site of the Food and Drug Administration. 
(2) A request is described in this paragraph if—
(A) the request pertains to a controlled substance on the 
list of drugs in shortage maintained under section 506E of the Federal Food, Drug, and Cosmetic Act; 
(B) the request is submitted by the manufacturer of the controlled substance; and 
(C) the controlled substance is in schedule II. 
As Amended Through P.L. 115-91, Enacted December 12, 2017 
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January 16, 2018 

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