Page:United States Statutes at Large Volume 90 Part 1.djvu/628

 90 STAT. 578 21 USC 352. Notice and hearing.

21 USC 321. Ante, p. 546. Ante, p. 562. Ante, p. 564.

21 USC 381.

21 USC 360b. Ante, p. 552. Ante, p. 560.

PUBLIC LAW 94-295—MAY 28, 1976 established name as defined in section 502(e), printed prominently and in type at least half as large as that used for any trade or brand name thereof, and (2) a brief statement of the intended uses of the device and relevant warnings, precautions, side effects, and contraindications and, in the case of specific devices made subject to a finding by the Secretary after notice and opportunity for comment that such action is necessary to protect the public health, a full description of the components of such device or the formula showing quantitatively each ingredient of such device to the extent required in regulations which shall be issued by the Secretary after an opportunity for a hearing. Except in extraordinary circumstances, no regulation issued under this paragraph shall require prior approval by the Secretary of the content of any advertisement and no advertisement of a restricted device, published after the effective date of this paragraph shall, with respect to the matters specified in this paragraph or covered by regulations issued hereunder, be subject to the provisions of sections 12 through 15 of the Federal Trade Commission Act (15 U.S.C. 52-55). This paragraph shall not be applicable to any printed matter which the Secretary determines to be labeling as defined in section 201(m). "(s) If it is a device subject to a performance standard established under section 514, unless it bears such labeling as may be prescribed in such performance standard. " (t) If it is a device and there was a failure or refusal (1) to comply with any requirement prescribed under section 518 respecting the device, or (2) to furnish any material or information required by or under section 519 respecting the device.". (2) Section 502(j) is amended by inserting "or manner" after "dosage". Amendments to Section 801 (f)(1) Section 801(d) is amended to read as follows: "(d)(1) A food, drug, device, or cosmetic intended for export shall not be deemed to be adulterated or misbranded under this Act if it— "(A) accords to the specifications of the foreign purchaser, "(B) is not in conflict with the laws of the country to which it is intended for export, "(C) is labeled on the outside of the shipping package that it is intended for export, and "(D) is not sold or offered for sale in domestic commerce. This paragraph does not authorize the exportation of any new animal drug, or an animal feed bearing or containing a new animal drug, which is unsafe within the meaning of section 512. " (2) Paragraph (1) does not apply to any device— "(A) which does not comply with an applicable requirement of section 514 or 515, "(B) which under section 520(g) is exempt from either such section, or "(C) which is a banned device under section 516, unless, in addition to the requirements of paragraph (1), the Secretary has determined that the exportation of the device is not contrary to public health and safety and has the approval of the country to which it is intended for export.". (2) Section 801(a)(1) is amended by inserting after "conditions" the following: "or, in the case of a device, the methods used in, or the facilities or controls used for, the manufacture, packing, storage,

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