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S.A.F.E. Compounded Drugs Act of 2012
Legislative Progress
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
24pct
2d open
vs 6,662 other HR bills in the 112th — cohort avg 39d
No CRS summary is available for this bill yet. The source title, actions, sponsors, and text versions below come from Congress.gov.
These links require the bill number to appear in the filing's source-reported specific issue text. Client expenses and lobbying-firm income are separate disclosure fields.
Filing registrants (5)
2012 · fourth_quarter · Pharmacy
Regarding coverage of medications for mental health and substance use disorders in health care reform law (ACA) Medicare Decisions Accountability Act of 2011 (HR 452/S. 668) S.A.F.E. Compounded Drugs Act of 2012 (H.R.6638)
Bills with similar content found using semantic analysis.
Sources: Congress.gov
Client expense: $8,158 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2012 · fourth_quarter · Pharmacy
H.R. 1971/S. 1058 - the "Pharmacy Competition and Consumer Choice Act of 2011," all provisions related to requirement of Pharmacy Benefit Managers annual reporting to Part D plan sponsors of number and total cost of prescriptions under a contract, payments to pharmacies, payments from pharmaceuticals manufacturers and generic and brand name drugs dispensed. H.R. 4215 - the "Medicare Pharmacy Transparency and Fair Auditing Act," amends Medicare Part D to require each contract entered into with a prescription drug plan (PDP) sponsor for the offering of a prescription drug plan to prohibit PDP sponsor from contracting with any pharmacy benefits manager (PBM) to manage the prescription drug coverage under such plan or control the costs of such coverage, unless the manager satisfies specific PBM audit and disclosure requirements. H.R. 6638, the Supporting Access to Formulated and Effective (SAFE) Compounded Drugs Act, all provisions requiring compounding pharmacies to register their facility with the FDA, requiring compounded drugs to be labeled appropriately, establishing an FDA database on compounding pharmacies and having the FDA set minimum production standards. Issues relating to regulations that would establish an effective drug identification and tracking system through which drug manufacturers, repackagers, wholesale distributors and dispensers may authenticate the wholesale distribution history of any prescription drug that is subject to a requirement for a standardized numerical identifier. No specific legislation.
Client expense: $790,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2012 · fourth_quarter · Pharmacy
FY 2014 Budget, FY 2013 Budget, Implementation of Health Care Reform, Implementation of Generic Biologics, Prescription Drug Safety, Counterfeit Drugs/Import Safety/Pedigree, Prescription Drug Shortages, Authorized Generics, Prescription Drug Importation/Re-Importation, drug shortages, prescription drug abuse and generic drugs H.R. 2182 Generating Antibiotic Incentives Now Act of 2011 H.R. 3026 - Safeguarding America's Pharmaceuticals Act of 2011 H.R. 3839 - Drug Shortage Prevention Act of 2012 H.R. 3988 - Generic Drug and Biosimilar User Fee Act of 2012 H.R. 3995 - Protecting Consumer Access to Generic Drugs Act of 2012 H.R. 4332 - Generic Drug Application Review Fairness Act of 2012 H.R. 5651 - Food and Drug Administration Reform Act of 2012 H.R.6160 - Stop Tampering of Prescription Pills Act of 2012 H.R. 6433 - FDA User Fee Corrections Act of 2012 H.R.6584 - Verifying Authority and Legality In Drug Compounding Act of 2012 H.R.6611 - Patient Access to Drugs in Shortage Act of 2012 H.R.6638 - S.A.F.E. Compounded Drugs Act of 2012 S. 44 Medicare Prescription Drug Negotiation Act S. 296 and H.R.2245 Preserving Access to Life-Saving Medication Act S. 373 Fair Prescription Drug Competition Act S. 1584 - Drug Safety and Accountability Act of 2011 S. 1734 - Generating Antibiotic Incentives Now Act of 2011 S. 2295 - Patient Safety and Generic Labeling Improvement Act S. 2516 - Food and Drug Administration Safety and Innovation Act S. 3187 Food and Drug Administration Safety and Innovation Act S.1855 - Pandemic and All-Hazards Preparedness Act Reauthorization of 2011
Client expense: $486,262 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
2012 · fourth_quarter · Pharmacy
H.R. 2182/S. 1734 - Generating Antibiotic Incentives Now Act . Supporting work to increase innovation and development of new antibiotics. S. 1584 - Drug Safety and Accountability Act- Supporting legislation and related Congressional activity regarding upstream supply stream safety. H.R. 3026- Safeguarding America's Pharmaceuticals Act. Supporting legislation and congressional activity regarding downstream supply chain safety. S. 3187 - The FDA Safety and Innovation Act- specific work on antibiotic innovation, up and down stream supply chain issues, and medical device policies. Policies related to the growing concerns regarding drug shortage issues in hospitals across the country. Potential language related to Track and Trace provisions regarding downstream supply chain safety being considered by the Senate HELP and House Energy and Commerce Committees. H.R. 6584 The Valid Compounding Act - Providing input regarding safe standards and practices for compounding pharmacies H.R. 6638 - S.A.F.E Compounded Drugs Act - Providing input regarding safe standards and practices for compounding pharmacies H.R. 8 - The American Taxpayer Relief Act of 2012- Focused on provisions that could have an impact on the nation's public health system.
Client expense: Not reported · Firm income: $30,000
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2012 · fourth_quarter · Health Issues
H.R. 2182/S.1734 - The Generating Antibiotic Incentives Now Act. Supporting work to increase innovation in the development of new antibiotics. S. 1584 - The Drug Safety and Accountability Act. Supporting upstream supply chain safety issues. S. 3026 - Safeguarding America's Pharmaceuticals Act Supporting downstream supply chain issues. Implementation and rulemaking related to the Physician Payment Sunshine Act - A Medicare-related provision in the Health Reform Law focused on increasing systemic transparency. S. 3295- The Department of Labor, Health and Human Services, Education and Related Agencies Appropriations Act of 2013. Supporting report language clarifying congressional intent for the funding of the Physician Payment Sunshine Act. Improvement of safety and efficacy of medical devices. Work related to treatment of medical devices in the upcoming FDA user fee arena. S. 3187 - The FDA Safety and Innovation Act- specific work on antibiotic innovation, up and down stream supply chain issues, and medical device policies. H.R. 6584 The Valid Compounding Act - Providing input regarding safe standards and practices for compounding pharmacies H.R. 6638 - S.A.F.E Compounded Drugs Act - Providing input regarding safe standards and practices for compounding pharmacies H.R. 8 - The American Taxpayer Relief Act of 2012- Focused on provisions that could have an impact on the nation's public health system.
Client expense: Not reported · Firm income: $30,000
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2012 · fourth_quarter · Health Issues
Issues related to the compounding pharmacies, in particular relating to FDA action to ban the hormone estriol from compounded estrogens. No specific legislation introduced yet. Legislation affecting the operation of compounding pharmacies and the availability of compounded medications. No specific legislation has been introduced yet. H.R. 6584, Verifying Authority and Legality In Drug Compounding Act of 2012. H.R. 6638, S.A.F.E. Compounded Drugs Act of 2012.
Client expense: Not reported · Firm income: $11,250
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2012 · fourth_quarter · Health Issues
Issues related to the compounding pharmacies, in particular relating to FDA action to ban the hormone estriol from compounded estrogens. No specific legislation introduced yet. Legislation affecting the operation of compounding pharmacies and the availability of compounded medications. No specific legislation has been introduced yet. H.R. 6584, Verifying Authority and Legality In Drug Compounding Act of 2012. H.R. 6638, S.A.F.E. Compounded Drugs Act of 2012.
Client expense: Not reported · Firm income: $11,250
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2012 · fourth_quarter · Health Issues
Issues related to the compounding pharmacies, in particular relating to FDA action to ban the hormone estriol from compounded estrogens. No specific legislation introduced yet. Legislation affecting the operation of compounding pharmacies and the availability of compounded medications. No specific legislation has been introduced yet. H.R. 6584, Verifying Authority and Legality In Drug Compounding Act of 2012. H.R. 6638, S.A.F.E. Compounded Drugs Act of 2012.
Client expense: Not reported · Firm income: $11,250
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2012 · fourth_quarter · Health Issues
Issues related to the compounding pharmacies, in particular relating to FDA action to ban the hormone estriol from compounded estrogens. No specific legislation has been introduced yet. Legislation affecting the operation of compounding pharmacies and the availability of compounded medications. No specific legislation has been introduced yet. H.R. 6584, Verifying Authority and Legality In Drug Compounding Act of 2012. H.R. 6638, S.A.F.E. Compounded Drugs Act of 2012.
Client expense: Not reported · Firm income: $6,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2012 · fourth_quarter · Health Issues
Issues related to the compounding pharmacies, in particular relating to FDA action to ban the hormone estriol from compounded estrogens. No specific legislation has been introduced yet. Legislation affecting the operation of compounding pharmacies and the availability of compounded medications. No specific legislation has been introduced yet. H.R. 6584, Verifying Authority and Legality In Drug Compounding Act of 2012. H.R. 6638, S.A.F.E. Compounded Drugs Act of 2012.
Client expense: Not reported · Firm income: $11,810
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2012 · fourth_quarter · Health Issues
FDA reform and legislation related to dietary supplements. S. 216, Food Safety Accountability Act of 2011, to increase criminal penalties for certain knowing and intentional violations relating to food that is misbranded or adulterated. Monitor development of regulations by the FDA that overly restrict the dietary supplement industry. Support language in Agriculture Appropriations Act (H.R. 5973) to restrict scope of FDA regulations concerning dietary supplements. H.R. 1364, Free Speech About Science Act of 2011. Legislation to allow growers of healthy foods and manufacturers of dietary supplements to cite legitimate scientific studies on the health benefits of these products without having them classified as unapproved new drugs. S. 1098/H.R. 2010, the Family Retirement and Health Investment Act, increasing limits of and making improvements to Health Savings Accounts, and allowing for dietary supplements to be included as qualified medical costs. Monitor development of regulations by the FDA that overly restrict the dietary supplement industry. No specific legislation yet. Oppose legislation to amend the Controlled Substances Act to prevent the alleged abuse of dehydroepiandrosterone. FDA authority and regulation of dietary supplements, specifically with regards to a current DOD initiative/review of products containing DMAA. No legislation is applicable or expected. H.R. 6584, Verifying Authority and Legality In Drug Compounding Act of 2012. H.R. 6638, S.A.F.E. Compounded Drugs Act of 2012.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE