3.0.0 2186 2019-11-15T21:18:23Z 2019-11-15T21:18:23Z House H HR 2013-05-23 113 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. MARKEY:H.R. 2186.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8, Clause 3[Page H2957]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2013-05-24T15:55:31Z Referred to 2013-05-23T13:04:25Z 2013-05-24 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2013-05-23 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2013-05-23 Introduced in House IntroReferral Intro-H 9 Library of Congress 2013-05-23 Introduced in House IntroReferral 1000 9 Library of Congress M000133 Rep. Markey, Edward J. [D-MA-5] Edward Markey D MA J. 5 N S000480 Rep. Slaughter, Louise McIntosh [D-NY-25] LOUISE SLAUGHTER D NY M. 25 2013-05-23 True C001049 Rep. Clay, Wm. Lacy [D-MO-1] WM. CLAY D MO LACY 1 2013-05-23 True R000053 Rep. Rangel, Charles B. [D-NY-13] CHARLES RANGEL D NY B. 13 2013-05-23 True E000215 Rep. Eshoo, Anna G. [D-CA-18] ANNA ESHOO D CA G. 18 2013-06-12 False Health Administrative law and regulatory procedures Administrative remedies Department of Health and Human Services Drug safety, medical device, and laboratory regulation Food and Drug Administration (FDA) Government information and archives Health care quality Health personnel Licensing and registrations Manufacturing Prescription drugs Retail and wholesale trades Small business User charges and fees Health 00 2013-05-23 Introduced in House 2013-09-23T20:58:04Z Verifying Authority and Legality In Drug Compounding Act of 2013 or VALID Compounding Act - Amends the Federal Food, Drug, and Cosmetic Act with respect to the regulation of compounding drugs.

Requires the Secretary of Health and Human Services (HHS) to develop and maintain a list of bulk substances from which drug products may be compounded that specifies any limitation on compounding of the substance and the particular medical need that is met by placing such substance on the list. Requires the Secretary to receive and consider petitions from any person identifying a substance that should be added to or removed from the list. Sets forth requirements for such petitions. Requires the Secretary also to develop and maintain a list of drug products that should not be compounded.

Allows a pharmacy to compound drugs which are not for an identified individual patient based on the receipt of a prescription order if the pharmacy registers with the Secretary and agrees to comply with any condition of operation or limitation of activity the Secretary specifies. Sets forth information that must be included in any such registration.

Authorizes the compounding of a drug that is a copy of a commercially available drug product if: (1) the drug is on the drug shortage list with notice given to the Secretary by the pharmacy, or (2) the drug product is necessary to protect public health and well-being. Requires the pharmacy to demonstrate to the Secretary that controls will be used that are comparable to elements required for safe use for a drug subject to a risk evaluation and mitigation strategy.

Requires the Secretary to establish standards, processes, and procedures for high-risk sterile compounding.

Establishes requirements related to inspections, labeling, and adverse event reporting for compounded drugs.

Requires the Secretary to assess an annual establishment fee from compounding pharmacies and a reinspection fee for any pharmacy subject to a reinspection in a fiscal year. Sets forth a methodology for setting such fees and requires reduced fees for small businesses (pharmacies with $1 million or less in annual sales).

States that the requirements of this Act do not preempt any non-federal requirement that is in addition to, and compatible with, such requirements.

]]> VALID Compounding Act Short Titles as Introduced VALID Compounding Act Short Titles as Introduced Verifying Authority and Legality In Drug Compounding Act of 2013 Display Title VALID Compounding Act Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act to provide for the compounding of drug products. Introduced in House 2013-05-23T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-113hr2186ih/xml/BILLS-113hr2186ih.xml 2013-05-24 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.