Page:United States Statutes at Large Volume 86.djvu/603

 86 STAT. ]

PUBLIC LAW 92-387-AUG. 16, 1972

561

"(2) Each person who registers with the Secretary under this sec- Reports. tion shall report to the Secretary once during the month of June of each year and once during the month of December of each year the ,,,,,^,., following information: " (A) A list of each drug introduced by the registrant for commercial distribution which has not been included in any list pre,,,,^,. viously filed by him with the Secretary under this subparagraph or paragraph (1) of this subsection. A list under this subparagraph shall list a drug by its established name (as defined in section 502(e)) and by any proprietary name it may have and shall 52 Stat. loso; be accompanied by the other information required by paragraph ^%TvscVs2 " (B) If since the date the registrant last made a report under this paragraph (or if he has not made a report under this paragraph, since the effective date of this subsection) he has discontinued the manufacture, preparation, propagation, compounding, or processing for commercial distribution of a drug included in a list filed by him under subparagraph (A) or paragraph (1); notice of such discontinuance, the date of such discontinuance, and the identity (by established name (as defined in section 502 (e)) and by any proprietary name) of such drug. " (C) If since the date the registrant reported pursuant to subparagraph (B) a notice of discontinuance he has resumed the manufacture, preparation, propagation, compounding, or processing for commercial distribution of the drug with reSpect to which such notice of discontinuance was reported; notice of such resumption, the date of such resumption, the identity of such drug (by established name (as defined in section 502(e)) and by any proprietary name), and the other information required by paragraph (1), unless the registrant has previously • ^ --• reported such resumption to the Secretary pursuant to this subparagraph. " (D) Any material change in any information previously submitted pursuant to this paragraph or paragraph (1). "(3) The Secretary may also require each registrant under this sec- ,. ^'"^ product tion to submit a list of each drug product which (A) the registrant is list. manufacturing, preparing, propagating, compounding, or processing for commercial distribution, and (B) contains a particular ingredient. The Secretary may not require the submission of such a list unless he has made a finding that the submission of such a list is necessary to carry out the purposes of this Act." 76 Stat. 794. SEC. 4. (a) Section 510(e) of such Act is amended by adding at the 21 USC 360. end thereof the following: "The Secretary may also assign a listing number to each drug or class of drugs listed under subsection (j). Any Ante, p. 560. number assigned pursuant to the preceding sentence shall be the same as that assigned pursuant to the National Drug Code.". (b) Section 510(f) of such Act is amended by inserting before the period the following: "; except that any list submitted pursuant to paragraph (3) of subsection (j) and the information accompanying any list or notice filed under paragraph (1) or (2) of that subsection shall be exempt from such inspection unless the Secretary finds that such an exemption would be inconsistent with protection of the public health".

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