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  • Regulatory NewsRegulatory News

    Two-Day FDA Advisory Committee Meeting to Address Drug Compounding Questions

    The US Food and Drug Administration (FDA) will host a two-day public advisory committee meeting on 27 and 28 October to look into updating a list of bulk drug substances that should not be compounded, and another list of substances that can be compounded. Background The  Drug Quality and Security Act (DQSA)  of 2013 was passed in the wake of a deadly outbreak of fungal meningitis caused by  deficient compounding practices  at a Massachusetts-based company. Historicall...
  • Regulatory NewsRegulatory News

    India Fines GSK, Sanofi for Alleged Anti-Competitive Practices

    The Indian subsidiaries of two European drugmakers, GlaxoSmithKline (GSK) and Sanofi, have been fined for allegedly plotting to charge higher prices in a government tender for a meningitis vaccine, The Economic Times reports. Investigation and Allegations The Competition Commission of India (CCI) is tasked with enforcing The Competition Act , which "prohibits anti-competitive agreements, abuse of dominant position by enterprises," and oversees corporate mergers a...
  • Feature ArticlesFeature Articles

    Public Safety Concerns Support FDA Call for Compounding Pharmacy Regulation

    When a contaminated injected steroid that killed more than 63 people and sickened at least 750 in 20 states was traced back to the New England Compounding Center (NECC) in Massachusetts, national attention turned to compounding pharmacies. 1 The public wanted to know what these businesses are and whether they are adequately regulated. Both the US Food and Drug Administration (FDA) and state authorities play a role in regulating compounding pharmacies. Unlike pharmacies t...
  • Hamburg: Compounding, Global Regulatory Issues Top Two Upcoming Areas of Regulatory Focus

    Pharmaceutical compounding and global supply chain issues are the two largest regulatory areas of upcoming focus for the US Food and Drug Administration (FDA), Commissioner Margaret Hamburg said in a 2 March 2013 interview with Yale University's The Politic . Compounding Issues Remain In the wide-ranging interview, Hamburg talked about the issues associated with pharmaceutical compounding and a recent outbreak of meningitis several times. In response to a question re...
  • Legislators Threaten to Subpoena FDA over Requested Documents

    US regulators are coming under renewed scrutiny regarding their oversight of pharmaceutical compounders, with House legislators threatening to subpoena the US Food and Drug Administration for what they allege is a failure to provide relevant documents to the Energy and Commerce Committee despite repeated requests. Background In 2012, a rash of drug shortages caused an increase in the number of entities looking to utilize the services of pharmaceutical compounders, which...
  • Massachusetts Looks to Clamp Down on Compounding in Wake of Scandal

    • 07 January 2013
    • By
    The governor of Massachusetts, Deval Patrick, has proposed new laws in a bid to strengthen the manner in which the state regulates the compounding of certain drug products. The development comes after hundreds of people were made ill and dozens more killed by pharmaceutical products compounded at a Framingham, MA-based company. That company, the New England Compounding Center (NECC), was found by regulators to have been manufacturing products contaminated with fungal men...
  • Senators Press State Regulators on Compounding Oversight

    • 20 November 2012
    • By
    Federal officials may have received the bulk of legislators' ire during two separate hearings on the safety of pharmaceutical compounding products in recent hearings, but now Senate legislators are taking aim at state regulators, asking whether those authorities have adequate resources in place to protect public health. In a letter sent to all 50 state boards of pharmacy on 19 November 2012, bipartisan members of the Senate's Health, Education, Labor and Pensions (HELP...
  • Legislators Slam Hamburg for Failing to Halt Meningitis Outbreak

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg was faced with skeptical and at times angry questioning by legislators at a hearing regarding a recent outbreak of fungal meningitis that has killed dozens and made hundreds ill. In her prepared testimony, Hamburg said the crisis had been caused by a confusing patchwork of regulation in which FDA theoretically had authority over some, but not all, compounding operations, but was consistently operating in...
  • Hamburg Calls for New Regulatory Authority in Wake of Compounding Scandal

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg has called upon Congress to grant the agency new authorities to regulate and oversee pharmaceutical compounders with the help of a new regulatory paradigm, according to testimony scheduled to be delivered before a House subcommittee. Hamburg is scheduled to appear at a 10 a.m. hearing before the House Energy and Commerce committee to discuss FDA's response to the meningitis outbreak which has resulted ...
  • FDA Inspectors Find Insects, Animal, Contamination at Compounding Facility

    Inspectors with the US Food and Drug Administration (FDA) have found microbial contamination, unevaluated adverse event reports, ongoing water leaks, contaminated hoods, multi-colored residues, insects and at least one bird in a compounding pharmacy owned by the same company now associated with a massive outbreak of fungal meningitis. The observations-made in a FDA Form 483 inspection report of compounder Ameridose's Westborough, MA facility-closely track a 483 release...
  • Congress Calls on Hamburg, Compounding Pharmacist to Testify at Hearing

    Some people get invitations to appear before Congress; others, subpoenas. Barry Cadden, co-owner of the New England Compounding Center (NECC), is of the latter category. The House Energy and Commerce (E&C) Committee announced on 6 November that it had sent a subpoena to Cadden, whose company has been linked to an outbreak of fungal meningitis that has claimed the lives of dozens of patients and made hundreds more ill. The E&C Committee has scheduled a high-pr...
  • New Legislation Aims to Provide FDA with New Authority to Regulate Compounders

    US Rep. Ed Markey (D-MA) plans to introduce a new piece of legislation he says will give the US Food and Drug Administration (FDA) new authority to regulate compounding pharmacies while still preserving state-level oversight authority. Markey's bill, the Verifying Authority and Legality in Drug (VALID) Compounding Act of 2012 , is an attempt to rectify a "regulatory black hole" responsible for letting through dangerous products that have killed dozens of patients an...