3.0.0 1959 2022-11-01T18:47:27Z 2022-11-01T18:47:27Z House HR 2019-03-28 116 [Congressional Record Volume 165, Number 54 (Thursday, March 28, 2019)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. GRIFFITH:H.R. 1959.Congress has the power to enact this legislation pursuantto the following:This bill is enacted pursuant to the power granted toCongress under Article I, Section 8 of the United StatesConstitution.[Page H2918]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2019-03-29T18:48:02Z Referred to 2019-03-28T13:05:30Z 2019-03-29 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2019-03-28 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2019-03-28 Introduced in House IntroReferral Intro-H 9 Library of Congress 2019-03-28 Introduced in House IntroReferral 1000 9 Library of Congress G000568 Rep. Griffith, H. Morgan [R-VA-9] H. Griffith R VA Morgan 9 N C001063 Rep. Cuellar, Henry [D-TX-28] Henry Cuellar D TX 28 2019-03-28 True C001103 Rep. Carter, Earl L. "Buddy" [R-GA-1] Earl Carter R GA L. "Buddy" 1 2019-04-09 False H001056 Rep. Herrera Beutler, Jaime [R-WA-3] Jaime Herrera Beutler R WA 3 2019-04-10 False B001250 Rep. Bishop, Rob [R-UT-1] Rob Bishop R UT 1 2019-04-12 False S001192 Rep. Stewart, Chris [R-UT-2] Chris Stewart R UT 2 2019-04-12 False P000609 Rep. Palmer, Gary J. [R-AL-6] Gary Palmer R AL J. 6 2019-04-12 False C001067 Rep. Clarke, Yvette D. [D-NY-9] Yvette Clarke D NY D. 9 2019-04-12 False J000302 Rep. Joyce, John [R-PA-13] John Joyce R PA 13 2019-04-15 False V000133 Rep. Van Drew, Jefferson [D-NJ-2] Jefferson Van Drew D NJ 2 2019-04-25 False F000449 Rep. Fortenberry, Jeff [R-NE-1] Jeff Fortenberry R NE 1 2019-04-25 False B001302 Rep. Biggs, Andy [R-AZ-5] Andy Biggs R AZ 5 2019-04-29 False A000367 Rep. Amash, Justin [R-MI-3] Justin Amash R MI 3 2019-05-07 False F000466 Rep. Fitzpatrick, Brian K. [R-PA-1] Brian Fitzpatrick R PA K. 1 2019-05-14 False N000189 Rep. Newhouse, Dan [R-WA-4] Dan Newhouse R WA 4 2019-05-15 False G000571 Rep. Gabbard, Tulsi [D-HI-2] Tulsi Gabbard D HI 2 2019-05-16 False H001077 Rep. Higgins, Clay [R-LA-3] Clay Higgins R LA 3 2019-05-20 False L000589 Rep. Lesko, Debbie [R-AZ-8] Debbie Lesko R AZ 8 2019-05-22 False G000565 Rep. Gosar, Paul A. [R-AZ-4] Paul Gosar R AZ A. 4 2019-05-23 False R000575 Rep. Rogers, Mike D. [R-AL-3] Mike Rogers R AL 3 2019-05-30 False D000615 Rep. Duncan, Jeff [R-SC-3] Jeff Duncan R SC 3 2019-05-30 False T000238 Rep. Thornberry, Mac [R-TX-13] WILLIAM THORNBERRY R TX M. 13 2019-05-30 False B001289 Rep. Byrne, Bradley [R-AL-1] Bradley Byrne R AL 1 2019-06-03 False W000821 Rep. Westerman, Bruce [R-AR-4] Bruce Westerman R AR 4 2019-06-04 False S001183 Rep. Schweikert, David [R-AZ-6] David Schweikert R AZ 6 2019-06-04 False L000583 Rep. Loudermilk, Barry [R-GA-11] Barry Loudermilk R GA 11 2019-06-04 False C001051 Rep. Carter, John R. [R-TX-31] John Carter R TX R. 31 2019-06-04 False S001172 Rep. Smith, Adrian [R-NE-3] Adrian Smith R NE 3 2019-06-05 False R000582 Rep. Roe, David P. [R-TN-1] David Roe R TN P. 1 2019-06-06 False O000168 Rep. Olson, Pete [R-TX-22] Pete Olson R TX 22 2019-06-06 False K000362 Rep. King, Steve [R-IA-4] Steve King R IA 4 2019-06-10 False M001194 Rep. Moolenaar, John R. [R-MI-4] John Moolenaar R MI R. 4 2019-06-27 False G000560 Rep. Graves, Tom [R-GA-14] Tom Graves R GA 14 2019-07-16 False D000628 Rep. Dunn, Neal P. [R-FL-2] Neal Dunn R FL P. 2 2019-07-18 False B001305 Rep. Budd, Ted [R-NC-13] Ted Budd R NC 13 2019-07-22 False G000590 Rep. Green, Mark E. [R-TN-7] Mark Green R TN E. 7 2019-08-02 False H001074 Rep. Hollingsworth, Trey [R-IN-9] Trey Hollingsworth R IN 9 2019-08-06 False C001118 Rep. Cline, Ben [R-VA-6] Ben Cline R VA 6 2019-09-12 False W000804 Rep. Wittman, Robert J. [R-VA-1] Robert Wittman R VA J. 1 2019-09-13 False Y000033 Rep. Young, Don [R-AK-At Large] DON YOUNG R AK E. 0 2019-09-24 False P000599 Rep. Posey, Bill [R-FL-8] Bill Posey R FL 8 2019-10-21 False D000600 Rep. Diaz-Balart, Mario [R-FL-25] Mario Diaz-Balart R FL 25 2019-10-30 False L000585 Rep. LaHood, Darin [R-IL-18] Darin LaHood R IL 18 2020-02-04 False Health Administrative law and regulatory procedures Business records Department of Health and Human Services Drug safety, medical device, and laboratory regulation Nutrition and diet Prescription drugs Health 00 2019-03-28 Introduced in House 2021-09-12T18:05:56Z Preserving Patient Access to Compounded Medications Act of 2019

This bill addresses regulations governing compounding pharmacies.

The bill expands the circumstances under which a drug may be compounded (i.e., manufactured at small scale) to allow pharmacists and physicians to compound drugs for administration to patients in an office or clinical setting, in accordance with state law. (Compounded drugs are not required to meet certain federal requirements regarding manufacturing, labeling, or approval.)

Dietary supplements may be used in the compounding of a drug.

The bill exempts from interstate distribution limits the dispensing of a compounded drug from the facility where it is compounded to a patient or health facility.

The bill limits the scope of Food and Drug Administration (FDA) inspections of compounding pharmacies to certain equipment, materials, containers, and labeling. This aligns the scope of inspections of compounding pharmacies with the scope of inspections of other pharmacies. (Currently, the scope of inspections of compounding pharmacies is the same as the scope of inspections of drug manufacturers.)

The bill also eliminates the requirement for compounding pharmacies to register with the FDA as drug manufacturers.]]> Preserving Patient Access to Compounded Medications Act of 2019 Display Title Preserving Patient Access to Compounded Medications Act of 2019 Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act with respect to compounding pharmacies, and for other purposes. Introduced in House IH Short Title(s) as Introduced Preserving Patient Access to Compounded Medications Act of 2019 Introduced in House IH Introduced in House 2019-03-28T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116hr1959ih/xml/BILLS-116hr1959ih.xml 2019-03-29 Referred to the Subcommittee on Health. 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.