Sec. 102. Definitions
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/bill/117/s/4535/is/section-102·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 735 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379g ) is amended— in paragraph (1), in the matter following subparagraph (B), by striking an allergenic extract product, or and inserting does not include an application with respect to an allergenic extract product licensed before October 1, 2022, does not include an application with respect to a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022, does not include an application with respect to ; in paragraph (3), in the matter following subparagraph (C)— by inserting licensed before October 1, 2022, a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022, after an allergenic extract product ; and by adding at the end the following:
If a written request to place a product in the discontinued section of either of the lists described in subparagraph
(C)is submitted to the Secretary on behalf of an applicant, and the request identifies the date the product is, or will be, withdrawn from sale, then, for purposes of assessing the prescription drug program fee under section 736(a)(2), the Secretary shall consider such product to have been included in the discontinued section on the later of
(i)the date such request was received, or
(ii)if the product will be withdrawn from sale on a future date, such future date when the product is withdrawn from sale. For purposes of subparagraph (C), a product shall be considered withdrawn from sale once the applicant has ceased its own distribution of the product, whether or not the applicant has ordered recall of all previously distributed lots of the product, except that a routine, temporary interruption in supply shall not render a product withdrawn from sale. ; and by adding at the end the following: The term skin-test diagnostic product — means a product— for prick, scratch, intradermal, or subcutaneous administration; expected to produce a limited, local reaction at the site of administration (if positive), rather than a systemic effect; not intended to be a preventive or therapeutic intervention; and intended to detect an immediate or delayed-type skin hypersensitivity reaction to aid in the diagnosis of— an allergy to an antimicrobial agent; an allergy that is not to an antimicrobial agent, if the diagnostic product was authorized for marketing prior to October 1, 2022; or infection with fungal or mycobacterial pathogens; and includes positive and negative controls required to interpret the results of a product described in subparagraph (A). .
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