3.0.0 6584 2019-11-15T21:18:15Z 2019-11-15T21:18:15Z House H HR 2012-11-02 112 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. MARKEY:H.R. 6584.Congress has the power to enact this legislation pursuantto the following:Article I, Sec. 8, clause 3____________________[Page H6323]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2012-11-02T15:06:26Z Referred to 2012-11-02T14:01:05Z 2012-11-02 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2012-11-02 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2012-11-02 Introduced in House IntroReferral Intro-H 9 Library of Congress 2012-11-02 Introduced in House IntroReferral 1000 9 Library of Congress M000133 Rep. Markey, Edward J. [D-MA-7] Edward Markey D MA J. 7 N C001068 Rep. Cohen, Steve [D-TN-9] Steve Cohen D TN 9 2012-11-02 True S000480 Rep. Slaughter, Louise McIntosh [D-NY-28] LOUISE SLAUGHTER D NY M. 28 2012-11-02 True L000562 Rep. Lynch, Stephen F. [D-MA-9] Stephen Lynch D MA F. 9 2012-11-02 True O000085 Rep. Olver, John W. [D-MA-1] JOHN OLVER D MA W. 1 2012-11-02 True F000339 Rep. Frank, Barney [D-MA-4] BARNEY FRANK D MA 4 2012-11-27 False M000312 Rep. McGovern, James P. [D-MA-3] JAMES MCGOVERN D MA P. 3 2012-11-27 False C001049 Rep. Clay, Wm. Lacy [D-MO-1] WM. CLAY D MO LACY 1 2012-11-27 False R000053 Rep. Rangel, Charles B. [D-NY-15] CHARLES RANGEL D NY B. 15 2012-11-27 False Health Administrative law and regulatory procedures Administrative remedies Consumer affairs Department of Health and Human Services Drug safety, medical device, and laboratory regulation Food and Drug Administration (FDA) Government information and archives Health information and medical records Licensing and registrations Manufacturing Prescription drugs Retail and wholesale trades State and local government operations Health 00 2012-11-02 Introduced in House 2013-01-04T21:54:38Z Verifying Authority and Legality In Drug Compounding Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) with respect to the regulation of compounding drugs.

Eliminates authority for compounding pharmacies to: (1) compound drugs before the receipt of a valid prescription order, or (2) compound any drug product that is a copy of a commercially available drug.

Requires the Secretary of Health and Human Services (HHS) to develop, maintain and transmit to the appropriate state agencies a list of drug products that should not be compounded, including: (1) drug products whose compounding is reasonably likely to cause an adverse effect on their safety or effectiveness; and (2) drug products that have been withdrawn or removed from the market because they have been found to be unsafe or not effective.

Authorizes the Secretary to waive the requirement that a drug product must be compounded for an individually identified patient based on a valid prescription order or similar notation if compounding the drug product is necessary to address a drug shortage, or to protect public health or well-being. Prohibits the Secretary from authorizing a state to grant such waivers.

Authorizes the Secretary to waive the requirement that a drug product must be compounded for an individually identified patient based on a valid prescription order or similar notation if the pharmacy or pharmacist: (1) submits a satisfactory application to the Secretary; and (2) agrees to comply with any condition or limitation specified by the Secretary. Makes a pharmacy or pharmacist required to be registered under the FFDCA as a drug producer ineligible for a waiver. Permits the Secretary to authorize a state to grant such waivers applicable to compounded drug products sold or dispensed within the state pursuant to a memorandum of understanding between the Secretary and the state.

Authorizes the Secretary to waive the prohibition against compounding any drug product that is a copy of a commercially available drug if it is necessary to protect public health or well-being. Prohibits the Secretary from authorizing a state to waive such prohibition.

Subjects the facilities of any pharmacy receiving a waiver under this Act to inspection to determine compliance with this Act.

Requires the Secretary to publish notice at least 30 days before cancelling a waiver, unless it is necessary to prevent an adverse impact on public health or safety.

Sets forth a required label statement for any drug compounded pursuant to this Act.

Requires a pharmacist or physician compounding a drug product to report any adverse event associated with the use of the product within a specified time frame.

]]> Verifying Authority and Legality In Drug Compounding Act of 2012 Short Titles as Introduced Verifying Authority and Legality In Drug Compounding Act of 2012 Display Title Verifying Authority and Legality In Drug Compounding Act of 2012 Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act to provide for the compounding of drug products. Introduced in House 2012-11-02T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112hr6584ih/xml/BILLS-112hr6584ih.xml 2012-11-02 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.