3.0.0 3089 2023-01-11T13:24:12Z 2023-01-11T13:24:12Z House H HR 2013-09-12 113 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. GRIFFITH of Virginia:H.R. 3089.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 H5547]]]> hsif00 Energy and Commerce Committee House Standing Referred to 2013-09-12T13:01:50Z 2013-09-12 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2013-09-12 Introduced in House IntroReferral Intro-H 9 Library of Congress 2013-09-12 Introduced in House IntroReferral 1000 9 Library of Congress G000568 Rep. Griffith, H. Morgan [R-VA-9] H. Griffith R VA Morgan 9 N D000197 Rep. DeGette, Diana [D-CO-1] DIANA DEGETTE D CO 1 2013-09-12 True G000410 Rep. Green, Gene [D-TX-29] GENE GREEN D TX 29 2013-09-12 True F000445 Rep. Forbes, J. Randy [R-VA-4] J. Forbes R VA Randy 4 2013-09-16 False H001045 Rep. Harper, Gregg [R-MS-3] Gregg Harper R MS 3 2013-09-16 False W000804 Rep. Wittman, Robert J. [R-VA-1] Robert Wittman R VA J. 1 2013-09-18 False H000636 Rep. Hinojosa, Ruben [D-TX-15] RUBEN HINOJOSA D TX 15 2013-09-20 False Health Administrative law and regulatory procedures Advisory bodies Business records Department of Health and Human Services Drug safety, medical device, and laboratory regulation Fraud offenses and financial crimes Government information and archives Health care quality Health information and medical records Licensing and registrations Prescription drugs Retail and wholesale trades Small business User charges and fees Health 00 2013-09-12 Introduced in House 2014-01-10T21:45:20Z Compounding Clarity Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise requirements for the regulation of compounding drugs.

Revises the exemption of compounded drugs from certain new drug, labeling, and biological product requirements. Adds an exemption for drug products compounded by a licensed pharmacist or a licensed physician, pursuant to a non-patient-specific purchase order, which: (1) will be administered by a health care practitioner within a physician's office, a hospital, or another health care setting; and (2) meet other specified criteria.

Revises requirements for exempted bulk drug substances.

Prohibits the sale of a drug product by an entity other than the pharmacy or physician that compounded it.

Directs the Secretary of Health and Human Services (HHS) to develop a system for receiving and reviewing submissions from state boards of pharmacy: (1) describing actions taken against compounding pharmacies, or (2) expressing concerns that a compounding pharmacy may be acting in violation of one or more requirements of this section. Requires the Secretary to review such submissions and determine whether the pharmacy involved may be in violation of one or more compounding requirements.

Authorizes the Secretary to inspect a pharmacy's records to determine whether the pharmacy is in violation of one or more FFDCA requirements.

Exempts from certain new drug, labeling, and biological product requirements a drug product compounded for human use by a licensed pharmacist in a registered outsourcing facility if specified conditions, including labeling requirements, are met.

Establishes annual registration requirements for any outsourcing facility. Requires a facility to report to the Secretary biannually on what drugs are compounded in it and to submit adverse event reports. Subjects such facilities to a risk-based inspection schedule.

Requires the Secretary to: (1) publish a list of drugs presenting demonstrable difficulties for compounding that are reasonably likely to lead to an adverse effect on the safety or effectiveness of the drug, taking into account the risk and benefits to patients; and (2) convene an advisory committee on compounding before creating the list.

Requires the Secretary to assess an annual establishment fee on each outsourcing facility and a reinspection fee, as necessary.

Prohibits the intentional falsification of a required prescription, a purchase order, or patient name for a compounded drug.

Prohibits the intentional failure of an outsourcing facility to register.

]]> Compounding Clarity Act of 2013 Display Title Compounding Clarity Act of 2013 Official Title as Introduced To amend section 503A of the Federal Food, Drug, and Cosmetic Act with respect to pharmacy compounding. Introduced in House IH Short Titles as Introduced Compounding Clarity Act of 2013 Introduced in House 2013-09-12T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-113hr3089ih/xml/BILLS-113hr3089ih.xml 2013-09-12 Referred to the House Committee on Energy and Commerce. 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.