Posts Tagged ‘hydrocodone’
DEA and Morris & Dickson Announce Settlement
The Drug Enforcement Administration (DEA) recently announced a settlement with pharmaceutical distributor Morris & Dickson Co., LLC (Morris & Dickson) for failing to maintain effective controls against diversion of controlled substance, which included the failure to report thousands of unusually large orders of oxycodone and hydrocodone. As part of the settlement last month, Morris &…
Read MoreFDA Revises Labeling to Limit Pediatric Use of Opioid Cough and Cold Medicines
Today, the FDA announced that it is requiring safety labeling changes to limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in children younger than 18 years old. Once the labeling changes are made, these products will not be indicated to treat cough in any pediatric population and will be…
Read MorePharmacists Must Ensure Prescription Orders are Issued for a Legitimate Medical Purpose by an Authorized Prescriber and Have a Recognized Medical Utility or Application
As discussed previously on the Baer Law Blog, corresponding responsibility remains one of the most misunderstood or unknown concepts found in the Drug Enforcement Administration’s (DEA) regulations. The DEA’s regulations (21 CFR 1306.04) regarding corresponding responsibility state: A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an…
Read MoreHydrocodone Combination Products Moving to Schedule II
On August 22, the Drug Enforcement Agency (DEA) published a final rule to move hydrocodone combination products (HCPs) from Schedule III to Schedule II. The change takes effect on October 6, 2014. Under the finale rule, all Schedule II requirements with respect to security, labeling and packaging, inventory, record keeping and reporting, etc., will apply to…
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