S.Amdt. 2136
What it does: Adds SEC. 10__. CIVIL PENALTIES FOR FAILURE TO SUBMIT NOTIFICATION at the end of title X
Sen. Richard Blumenthal (D-CT)What it changes
1 change to S. 3187 · shown in the bill's text
Adds SEC. 10__. CIVIL PENALTIES FOR FAILURE TO SUBMIT NOTIFICATION at the end of title X
Adds a sectionIn S. 3187 · Placed on Calendar Senate
(e) Guidance Regarding Repackaging.--Not later than 1 year after the date of enactment of this Act, the Secretary shall issue guidance that clarifies the policy of the Food and Drug Administration regarding hospital pharmacies repackaging and safely transferring repackaged drugs among hospitals within a common health system during a drug shortage, as identified by the Secretary.
Inserted: SEC. 10__. CIVIL PENALTIES FOR FAILURE TO SUBMIT NOTIFICATION.
Inserted: Section 303 (21 U.S.C. 333) is amended--
Inserted: (1) in subsection (f)(5), by inserting "or subsection (h)" after "or (9)" each place such term appears; and
Inserted: (2) by adding at the end the following:
Inserted: "(h)(1) Any manufacturer that knowingly fails to submit a notification in violation of section 506C(a) shall be subject to a civil money penalty not to exceed $10,000 for each day on which the violation continues, and not to exceed $1,800,000 for all such violations adjudicated in a single proceeding.
Inserted: "(2) Not later than 180 days after the date of enactment of the Food and Drug Administration Safety and Innovation Act, the Secretary shall, subject to paragraph (1), promulgate final regulations establishing a schedule of civil monetary penalties for violations of section 506C(a).".
Original wording
At the end of title X, add the following:
Read automatically from the Congressional Record. Check the original before relying on it.
As printed
SA 2136. Mr. BLUMENTHAL (for himself, Mr. Franken, Mr. Schumer, Mr. Cardin, and Ms. Klobuchar) submitted an amendment intended to be proposed by him to the bill S. 3187, to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes; which was ordered to lie on the table; as follows:
At the end of title X, add the following:
SEC. 10__. CIVIL PENALTIES FOR FAILURE TO SUBMIT NOTIFICATION.
Section 303 (21 U.S.C. 333) is amended--
(1) in subsection (f)(5), by inserting “or subsection (h)” after “or (9)” each place such term appears; and
(2) by adding at the end the following:
“(h)(1) Any manufacturer that knowingly fails to submit a notification in violation of section 506C(a) shall be subject to a civil money penalty not to exceed $10,000 for each day on which the violation continues, and not to exceed $1,800,000 for all such violations adjudicated in a single proceeding.
“(2) Not later than 180 days after the date of enactment of the Food and Drug Administration Safety and Innovation Act, the Secretary shall, subject to paragraph (1), promulgate final regulations establishing a schedule of civil monetary penalties for violations of section 506C(a).”.
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Senate amendment submitted
May 22, 2012