Legislation planned to tighten oversight of compounding pharmacies

Nov 3 2012

Rep. Edward J. Markey, D-Mass., will introduce legislation requiring compounding pharmacies to meet the sterility, record-keeping and manufacturing standards faced by large drug makers.

The Wall Street Journal: Bill Would Tighten Pharmacy Rules
Lawmakers are assembling legislation that would give the Food and Drug Administration clearer authority to regulate large pharmacies that mix customized drugs like the one tied to a deadly meningitis outbreak. On Friday, Rep. Edward J. Markey (D., Mass.) plans to introduce a bill that would require large compounding pharmacies to meet the same sterility, manufacturing and record-keeping standards as those required of large drug makers (Burton and Dooren, 11/1).

CQ HealthBeat: Markey Bill Would Set Standards For FDA Oversight Of Compounding Pharmacies
Massachusetts Democrat Edward J. Markey will introduce a bill Friday to clarify the Food and Drug Administration's authority over compounding pharmacies, the first such bill since the September outbreak of fungal meningitis. Markey, a member of the House Energy and Commerce Committee, said his bill would end "this regulatory black hole by giving the FDA new, clear authority." It would specify when the FDA can regulate compounding pharmacies, and when the pharmacies would be exempt from some regulations. It also would allow the FDA to provide waivers of its requirements for compounding pharmacies in certain circumstances (Ethridge, 11/1).

The Hill: House Dem Writes Bill Tightening Rules For Drug Compounders
Rep. Edward Markey (D-Mass.) is preparing to introduce a bill that would impose stricter regulations on drug compounders. Markey's district includes the Framingham-based New England Compounding Center (NECC), the pharmacy operation linked to 28 meningitis deaths around the country… "Compounding pharmacies have been governed by fragmented regulations for too long, leading to the worst public health disaster in recent memory," Markey said in a statement Thursday. His bill would require compounders that distribute medications on a large scale to register with the Food and Drug Administration (FDA) as drug makers, subjecting them to tougher rules (Viebeck, 11/1).

Meanwhile, House Oversight and Government Reform Committee Chairman Darrell Issa, R-Calif., is staying focused on efforts to undo certain parts of the health law  - 

Roll Call: Darrell Issa Keeps Health Care Law In His Sights
House Republicans are opening a new front in their drive to derail the 2010 health care overhaul, using an expedited legislative procedure to upend targeted parts of the law. Republican leaders are preparing to launch the effort during the post-election session that begins Nov. 13. But whether they will have the House vote on a resolution of disapproval intended to sideline an IRS rule related to the health care law hinges on who wins the presidential election. The resolution backed by Rep.Darrell Issa, the California Republican who heads the Oversight and Government Reform Committee, and  Rep. Scott DesJarlais, a Tennessee Republican and the measure's chief sponsor, is meant to nullify the upcoming IRS rule authorizing the distribution of subsidies through tax credits in every state, even the 35 that have not yet established state health care exchanges, as an incentive to get most Americans to buy insurance, a central tenant of the overhaul (Ota, 11/1).