3.0.0 1919 2023-01-11T13:24:55Z 2023-01-11T13:24:55Z House H HR 2013-05-09 113 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. LATTA:H.R. 1919.Congress has the power to enact this legislation pursuantto the following:Taxation: Article 1, Section 8, Clause 3The Congress shall have Power to regulate Commerce withforeign Nations, and among the several States, and with theIndian Tribes.[Page H2569]]]> sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2013-06-04T18:51:12Z hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2013-05-10T15:32:30Z Reported by 2013-06-03T19:58:08Z Referred to 2013-05-09T13:06:10Z H. Rept. 113-93 Drug Quality and Security Act 113 3204 HR 2013-11-27 Became Public Law No: 113-54. Related bill CRS 2013-06-04 sshr00 Health, Education, Labor, and Pensions Committee Senate Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2013-06-03 16:34:30 Motion to reconsider laid on the table Agreed to without objection. Floor H38310 2 House floor actions 2013-06-03 16:34:28 On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H2969-2978) Floor H37300 2 House floor actions 2013-06-03 16:34:28 Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.(text: CR H2969-2978) Floor 8000 9 Library of Congress 2013-06-03 16:03:18 DEBATE - The House proceeded with forty minutes of debate on H.R. 1919. Floor H8D000 2 House floor actions 2013-06-03 16:03:15 Considered under suspension of the rules. (consideration: CR H2968-2984) Floor H30000 2 House floor actions 2013-06-03 16:03:02 Mr. Latta moved to suspend the rules and pass the bill, as amended. Floor H30300 2 House floor actions 2013-06-03 Placed on the Union Calendar, Calendar No. 65. Calendars H12410 2 House floor actions U00065 2013-06-03 Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 113-93. Committee H12200 2 House floor actions hsif00 Energy and Commerce Committee 2013-06-03 Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 113-93. Committee 5000 9 Library of Congress hsif00 Energy and Commerce Committee 2013-05-10 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2013-05-09 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2013-05-09 Introduced in House IntroReferral Intro-H 9 Library of Congress 2013-05-09 Introduced in House IntroReferral 1000 9 Library of Congress L000566 Rep. Latta, Robert E. [R-OH-5] Robert Latta R OH E. 5 N M001142 Rep. Matheson, Jim [D-UT-4] JIM MATHESON D UT 4 2013-05-09 True U000031 Rep. Upton, Fred [R-MI-6] FRED UPTON R MI 6 2013-05-09 True D000355 Rep. Dingell, John D. [D-MI-12] JOHN DINGELL D MI D. 12 2013-05-09 True C001075 Rep. Cassidy, Bill [R-LA-6] Bill Cassidy R LA 6 2013-05-09 True B001243 Rep. Blackburn, Marsha [R-TN-7] Marsha Blackburn R TN 7 2013-05-09 True M001180 Rep. McKinley, David B. [R-WV-1] David McKinley R WV B. 1 2013-05-09 True R000572 Rep. Rogers, Mike J. [R-MI-8] Mike Rogers R MI 8 2013-05-09 True B001248 Rep. Burgess, Michael C. [R-TX-26] Michael Burgess R TX C. 26 2013-05-09 True S000364 Rep. Shimkus, John [R-IL-15] JOHN SHIMKUS R IL M. 15 2013-05-09 True G000558 Rep. Guthrie, Brett [R-KY-2] Brett Guthrie R KY 2 2013-05-09 True J000292 Rep. Johnson, Bill [R-OH-6] Bill Johnson R OH 6 2013-05-09 True S001190 Rep. Schneider, Bradley Scott [D-IL-10] Bradley Schneider D IL Scott 10 2013-05-09 True O000168 Rep. Olson, Pete [R-TX-22] Pete Olson R TX 22 2013-05-17 False L000576 Rep. Long, Billy [R-MO-7] Billy Long R MO 7 2013-05-17 False L000111 Rep. Latham, Tom [R-IA-3] TOM LATHAM R IA 3 2013-05-17 False V000129 Rep. Valadao, David G. [R-CA-21] David Valadao R CA G. 21 2013-05-21 False R000515 Rep. Rush, Bobby L. [D-IL-1] BOBBY RUSH D IL L. 1 2013-05-23 False V000131 Rep. Veasey, Marc A. [D-TX-33] Marc Veasey D TX A. 33 2013-06-03 False W000798 Rep. Walberg, Tim [R-MI-7] Tim Walberg R MI 7 2013-06-03 False W000813 Rep. Walorski, Jackie [R-IN-2] Jackie Walorski R IN 2 2013-06-03 False Health Administrative law and regulatory procedures Business records Computers and information technology Congressional oversight Department of Health and Human Services Drug safety, medical device, and laboratory regulation Federal preemption Food and Drug Administration (FDA) Fraud offenses and financial crimes Government information and archives Government studies and investigations Licensing and registrations Manufacturing Prescription drugs Retail and wholesale trades Small business State and local government operations User charges and fees Health 00 2013-05-09 Introduced in House 2013-10-10T20:16:53Z Safeguarding America's Pharmaceuticals Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to establish requirements to facilitate the tracing of drug products through the pharmaceutical supply distribution chain.

Requires the Secretary of Health and Human Services (HHS) to establish standards for the exchange of transaction information.

Requires the Secretary to establish processes to: (1) provide waivers of requirements for undue economic hardship or emergency medical reasons; (2) provide waivers of requirements relating to product identifiers for prescription drug products packaged without sufficient space to bear the information; and (3) determine other prescription drug products or transactions that should be exempt from the requirements of this Act.

Establishes requirements for drug manufacturers, wholesalers, dispensers, and repackagers to ensure that all prior transaction information is provided at each transfer of ownership. Requires such entities to maintain such transaction information for three years. Sets forth exceptions, including for dispensing to a patient and returns.

Requires a manufacturer, wholesale distributor, dispenser, repackager, in the event of a recall or for the purpose of investigating a suspect prescription drug product or an illegitimate prescription drug product, to provide within two business days the applicable transaction documentation upon request by the Secretary or other appropriate federal or state official.

Requires a manufacturer or repackager to affix or imprint a prescription drug product identifier on each package and homogenous case of a prescription drug product.

Requires a manufacturer, wholesale distributor, dispenser, repackager, or third party logistics provider to ensure that each of its trading partners is authorized.

Requires a manufacturer, wholesale distributor, dispenser, repackager, and third party logistics provider to implement systems to: (1) investigate suspected illegitimate prescription drug products or, for a third party logistics provider, notify the owner of a need for such an investigation, and (2) handle illegitimate prescription drug products, including through quarantine, disposal, and appropriate notice to the Secretary and, as necessary, trading partners.

Requires manufacturers, wholesale distributors, repackagers to verify returned products before further distribution.

Requires the Secretary to establish projects and hold public meetings to enhance the safety and security of the pharmaceutical distribution supply chain.

Requires the Secretary to issue additional proposed regulations in 2027 to prevent a suspect, illegitimate or counterfeit product, or a product otherwise unfit for distribution from entering into or being further distributed in the supply chain.

Requires the Secretary to establish standards for the licensing of wholesale distributors and third party logistics providers. Requires third party logistics providers to be licensed by the state from which the drug is distributed or by the Secretary.

Preempts state and local requirements related to tracing drugs through the distribution system, and licensure of wholesale distributors or third party logistics provider licensure.

Allows certain prescription drug labeling to be provided solely by electronic means.

]]> 36 2013-06-03 Passed House amended 2014-01-08T16:50:58Z Safeguarding America's Pharmaceuticals Act of 2013 - (Sec. 2) Amends the Federal Food, Drug, and Cosmetic Act to establish requirements to facilitate the tracing of drug products through the pharmaceutical supply distribution chain.

Requires the Secretary of Health and Human Services (HHS) to establish standards for the exchange of transaction information.

Requires the Secretary to establish processes to: (1) provide waivers of requirements for undue economic hardship or emergency medical reasons; (2) provide waivers of requirements relating to product identifiers for prescription drug products packaged without sufficient space to bear the information; and (3) determine other prescription drug products or transactions that should be exempt from the requirements of this Act.

Establishes requirements for drug manufacturers, wholesalers, dispensers, and repackagers to ensure that all prior transaction information is provided at each transfer of ownership. Requires such entities to maintain such transaction information for three years. Sets forth exceptions, including for dispensing to a patient and returns.

Requires a manufacturer, wholesale distributor, dispenser, repackager, in the event of a recall or for the purpose of investigating a suspect prescription drug product or an illegitimate prescription drug product, to provide within two business days the applicable transaction documentation upon request by the Secretary or other appropriate federal or state official.

Requires a manufacturer or repackager to affix or imprint a prescription drug product identifier on each package and homogenous case of a prescription drug product.

Requires a manufacturer, wholesale distributor, dispenser, repackager, or third party logistics provider to ensure that each of its trading partners is authorized.

Requires a manufacturer, wholesale distributor, dispenser, repackager, and third party logistics provider to implement systems to: (1) investigate suspected illegitimate prescription drug products or, for a third party logistics provider, notify the owner of a need for such an investigation, and (2) handle illegitimate prescription drug products, including through quarantine, disposal, and appropriate notice to the Secretary and, as necessary, trading partners.

Requires manufacturers, wholesale distributors, repackagers to verify returned products before further distribution.

(Sec. 3) Requires the Secretary to establish projects and hold public meetings to enhance the safety and security of the pharmaceutical distribution supply chain.

Directs the Comptroller General (GAO) to examine implementation of the requirements established under this Act in order to inform regulations promulgated to enhance distribution supply chain safety and security.

Directs the Secretary to contract with a private, independent consulting firm with relevant expertise to conduct a technology and software study on the feasibility of dispensers that have 25 or fewer full-time employees conducting interoperable, electronic tracing of prescription drug products at the package level.

Requires the Secretary to issue additional proposed regulations in 2027 to prevent a suspect, illegitimate or counterfeit product, or a product otherwise unfit for distribution from entering into or being further distributed in the supply chain.

(Sec. 4) Requires the Secretary to establish standards for the licensing of wholesale distributors and third party logistics providers. Requires third party logistics providers to be licensed by the state from which the drug is distributed or by the Secretary.

(Sec. 6) Applies specified criminal and civil penalties to violations of standards prescribed under this Act, including a certain enhanced penalty for knowing unlicensed activities, and failure to bear a prescription drug product identifier required by this Act.

(Sec. 7) Preempts state and local requirements related to tracing drugs through the distribution system, and licensure of wholesale distributors or third party logistics provider licensure.

(Sec. 8) Allows certain prescription drug labeling to be provided solely by electronic means.

]]> Safeguarding America's Pharmaceuticals Act of 2013 Display Title Safeguarding America's Pharmaceuticals Act of 2013 Short Titles as Introduced Safeguarding America's Pharmaceuticals Act of 2013 Short Titles as Reported to House Safeguarding America's Pharmaceuticals Act of 2013 H House Short Titles as Passed House Safeguarding America's Pharmaceuticals Act of 2013 H House Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act with respect to the pharmaceutical distribution supply chain, and for other purposes. Referred in Senate 2013-06-04T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-113hr1919rfs/xml/BILLS-113hr1919rfs.xml Engrossed in House 2013-06-03T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-113hr1919eh/xml/BILLS-113hr1919eh.xml Reported in House 2013-06-03T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-113hr1919rh/xml/BILLS-113hr1919rh.xml Introduced in House 2013-05-09T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-113hr1919ih/xml/BILLS-113hr1919ih.xml 2013-06-04 Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.