• RAPS' LatestRAPS' Latest

    RAPS Holiday Schedule Announced

    RAPS headquarters will close this year the week of 26 December and reopen 3 January 2017. Online orders from the RAPS Store may still be placed and will be shipped while the office is closed, and RAPS will still take 20% off all orders placed in December with the code: DEC20OFF. However, please note shipping times may be delayed for orders placed from 23 December through 4 January. Regulatory Focus will publish news and the RF Today e-newsletter will continue d...
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    FOIA'd Documents Show FDA's Rationale Against Marijuana Rescheduling

    In a report and other documents obtained by Vice News via the Freedom of Information Act (FOIA) , the US Food and Drug Administration (FDA) lays out its case against rescheduling marijuana. FDA's recommendation on the matter was cited by the Drug Enforcement Administration (DEA) when it denied two petitions to reschedule marijuana last August . Despite efforts by medical marijuana advocates and a growing number of states (25, plus the District of Columbia) where med...
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    Dramatic Drop in Hydrocodone Combo Prescriptions After DEA Rescheduling

    Prescriptions for hydrocodone combination products (HCPs) fell significantly after the US Drug Enforcement Agency (DEA) tightened restrictions on those drugs, according to a study published Monday in JAMA Internal Medicine . For years the US has been in the grips of a prescription drug abuse epidemic, in part driven by the availability of hydrocodone and other opioids such as oxycodone, codeine and methadone. In 2013, more than 200 million prescriptions for opioids we...
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    Australia Releases Updated Drug Schedule

    Australia has updated a legislative instrument designed to advise the country's states and territories on the scheduling and labeling of medicines and poisons. Background In Australia, like in many other countries, medicines and other chemicals are classified in a schedule system. The schedule is organized by the level of regulatory control required for different substances based on their safety and use. The legal basis for drug scheduling in Australia is found in ...
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    India Seeks Input on Draft Revisions to Device GMPs

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. India’s Central Drugs Standard Control Organization (CDSCO) is seeking input on draft revisions to Schedule M-III of the country’s Drug and Cosmetic Act , which describes good manufacturing practices (GMPs) for medical devices. The revisions aim to bring the GMP requi...
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    DEA Establishes Production Limits for Painkillers, With Some Drugs Set for Big Increases

    US drug regulators have set new production quotas for dozens of controlled substances regulated under the Controlled Substances Act (CSA) , establishing the quantities of the drugs which may be produced in 2015. Quota Adjustments In a 5 September 2014 Federal Register notice , the US Drug Enforcement Administration (DEA), which is charged with setting the quotas, released a list of dozens of schedule I and II controlled substances which will be subject to produc...
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    Merck's Insomnia Drug Belsomra Clears Final DEA Hurdle

    The US Drug Enforcement Administration (DEA) has given a final and long-awaited approval to Merck to market its new insomnia drug Belsomra (suvorexant) as a Schedule IV drug. Background Belsomra is an orexin receptor antagonist intended to treat insomnia in patients. While its sponsor, Merck, has already obtained FDA approval to market the drug, it has been awaiting scheduling by DEA as a controlled substance under the Controlled Substances Act (CSA) . In February 2...
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    DEA, Following FDA Recommendation, to Toughen Regulation on Popular Class of Painkillers

    In a long-anticipated move, the Drug Enforcement Administration (DEA) has announced it will now regulate all hydrocodone combination products as Schedule II drugs under federal law. The move follows an October 2013 recommendation by the US Food and Drug Administration (FDA), which also recommended that the drugs be regulated as Schedule II products under the Controlled Substances Act (CSA), a 1970 law which places controls on substances known to be dangerous, prone to ...
  • Canada Opens Consultation on New Prescription Drug List

    Health Canada has opened a consultation regarding the new Prescription Drug List that is scheduled replace the existing Schedule F of the Food and Drug Regulations. The regulatory process to add or remove a drug from Schedule F will be replaced by an administrative process, requiring the amendment of all existing regulations and draft regulations that have been developed.  Health Canada has also prepared a draft guidance document that explains the pri...
  • DEA Classifies Bath Salt Chemical as Schedule I Drug After Oversight

    • 18 October 2012
    The Drug Enforcement Administration (DEA) has placed methylone, a powerful stimulant and psychoactive drug most notorious for its presence in bath salts, into its Schedule I of highly restricted drugs with no accepted medical use within the US. The drug is chemically similar to other drugs like Ecstasy (MDMA), which has been a Schedule I drug under the Controlled Substances Act (CSA) since 1985. DEA's actions would act to put into place a more permanent solution, o...
  • Canada Accelerating Process by Which Drugs Undergo Prescription-to-OTC Switch

    Health Canada plans to get rid of its Schedule F drug regulations which govern which drugs may be sold over-the-counter (OTC) and which require a physician's prescription to purchase. The change is due to the onerous process by which drugs are added and removed to the schedule, which Health Canada said can take upwards of 20 months, even after regulators have determined the product is safe for consumers to purchase and use on their own. The delay, caused because a regul...