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  • Regulatory NewsRegulatory News

    FDA Warns Four Companies Selling Cannabidiol Over Unproven Claims

    The US Food and Drug Administration (FDA) on Wednesday warned four companies selling cannabidiol (CBD) containing products for making claims that their products can treat or cure cancer and other diseases, including Alzheimer's, arthritis, heart disease and stroke. "Selling these unapproved products with unsubstantiated therapeutic claims is not only a violation of the Federal Food, Drug and Cosmetic Act , but also can put patients at risk as these products have not bee...
  • Regulatory NewsRegulatory News

    FDA Seeks Comment on WHO Recommendations Restricting Certain Psychotropic Substances

    The Food and Drug Administration (FDA) on Tuesday offered a chance for those interested to submit written comments or request an informal public meeting on recommendations by the World Health Organization (WHO) to impose international manufacturing and distributing restrictions on certain drug substances. The comments received will be considered in preparing the US position on these proposals for a meeting of the UN Commission on Narcotic Drugs (CND) in Vienna, Austria,...
  • Regulatory NewsRegulatory News

    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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    UK’s MHRA: Products Containing Cannabis Extract are Medicines

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has recently come to the decision that products containing cannabidiol (CBD) are a medicine, following a regulatory review of such products. “We have come to the opinion that products containing cannabidiol (CBD) are a medicine. Products for therapeutic use must have a medicines’ licence before they can be legally sold, supplied or advertised in the UK. Products will have to meet safety, quality a...
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    Asia Regulatory Roundup: India Looks to Raise Drug Inspection Standards (20 October 2015)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CDSCO Creates Induction Program to Raise Standards at Inspectorate The Central Drugs Standard Control Organization (CDSCO) has set up an induction program to train assistant drug inspectors. A three-month training program, in which CDSCO will cover the regulatory framework in India and other topics, is the centerpiece of the induction strategy. CDSCO has introduced ...
  • Regulatory NewsRegulatory News

    Canada's Medical Marijuana Regulations, An Overview

    Following is a free preview of a Regulatory Focus feature article, normally exclusively available to RAPS members. For information about becoming a member, visit Join RAPS . This article presents an overview of Canada's medical marijuana regulations regarding individual prescription access and compliance measures for licensed producers. The narcotic marijuana (spelled "marihuana" in most official Canadian government communications) is not an approved drug or medicin...
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    DEA to Allow Huge Increase in Marijuana Production to Meet Research Demands

    The US Drug Enforcement Administration (DEA) has proposed a massive increase in the amount of marijuana it will allow to be produced this year in the hopes of meeting the demand of researchers studying new medicinal uses for the drug, it has announced. Background In the US, the manufacture and production of marijuana is controlled by the DEA, whose authority to do so stems from the Controlled Substances Act (CSA) —a law which categorizes drugs in accordance with their ...
  • Regulatory NewsRegulatory News

    DEA to Increase Marijuana Production Quota to Meet Demand of Medical Researchers

    The US Drug Enforcement Administration (DEA) is proposing to more than triple the amount of marijuana it will allow to be produced this year in the hopes of meeting the demand of researchers studying new medicinal uses for the drug, it has announced. Background In the US, the manufacture and production of marijuana is controlled by the DEA, whose authority to do so stems from the Controlled Substances Act (CSA) —a law which categorizes drugs in accordance with their ri...
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    Up in Smoke: Canadian Regulators Find Pot too Potent

    A licensed medical marijuana producer in Canada has issued a recall for its pot-based product, saying some batches of it are too strong. According to an information update on the Health Canada website, third party tests of samples of its "Nice N'EZ" product were found to exceed the product’s labeled strength for delta-9-tetahydrocannabinol, marijuana's active ingredient. Background Medical marijuana ( spelled ‘marihuana’ in some official documents) has been regulat...
  • As Medical Marijuana Hits Mainstream, Regulators Take Notice With Safety Recalls

    In the US, states are increasingly squaring off against federal regulators in an attempt to grant their citizens access to medical marijuana, which advocates argue can provide pain relief to patients afflicted with cancer or other painful conditions. But north of the US border, where medicinal marijuana is legal when authorized by a doctor or nurse practitioner, Canadian regulators are grappling with another marijuana issue entirely: The recall of medicinal marijuana due...