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  • Regulatory NewsRegulatory News

    FDA to Reclassify Pharmaceutical Co-Crystals

    As part of an effort to clarify and help advance the development of pharmaceutical co-crystals, the US Food and Drug Administration (FDA) on Tuesday released revised draft guidance providing information on the appropriate classification of co-crystal solid-state forms, the data that should be submitted to support the classification and the regulatory implications of such a classification. “Co-crystals are crystalline materials composed of two or more different molecules...
  • DEA Classifies Bath Salt Chemical as Schedule I Drug After Oversight

    • 18 October 2012
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    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...
  • Consumers Warned of Fake Adderall in US

    The US Food and Drug Administration (FDA) warned consumers on 29 May of counterfeit copies of Teva Pharmaceutical Industries' attention deficit hyperactive disorder (ADHD) drug Adderall, saying some consumers had obtained copies of the drug containing the incorrect active pharmaceutical ingredients (APIs) through an online pharmacy. ADHD drugs like Adderall use a combination of APIs known as amphetamine salts. In the case of Adderall, the drug contains dextroamphetamine ...
  • ADHD Drugs Remain in Short Supply

    A shortage of a medication used to treat attention deficit hyperactive disorder (ADHD) shows little sign of abating as the US Drug Enforcement Administration (DEA) continues to regulate the amphetamine salts that act as the drug's active pharmaceutical ingredient (API). The DEA controls the supply of the amphetamine salts via a manufacturing quota system, and authorizes certain amounts of the amphetamine salts to be distributed based on what the agency determines to be t...