DEA Suspends Opioid Manufacturer
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Issues Five Orders to Show Cause
WASHINGTON – On Oct. 31, the U.S. Drug Enforcement Administration announced administrative actions against six DEA-registered companies which, together, failed to account for more than a million doses of opioids. Under DEA initiative “Operation Bottleneck,” DEA served an Immediate Suspension Order and five Orders to Show Cause over a one-month period from Sept. 25 through Oct. 20, 2023.
“These companies have a legal obligation to account for every dose and every pill to protect the safety and health of the American people,” said DEA Administrator Anne Milgram. “As we continue to face an unprecedented drug poisoning and overdose epidemic in the United States, which took 110,757 lives last year alone, DEA will continue using every available tool to prevent the diversion and misuse of opioids and other highly addictive controlled substances.”
During the week of Sept. 25, DEA served two Orders to Show Cause setting forth allegations against Inmar RX Solutions, Inc., a reverse distributor, and Ascent Pharmaceuticals, Inc., a pharmaceutical manufacturer.
One of the largest reverse distributors in the country, Inmar RX Solutions, Inc., handles the return and disposal of medications. The company failed to comply with its obligation to maintain effective controls against the diversion of controlled substances. These violations include the persistent failure to properly report theft or significant loss, to timely destroy or promptly return controlled substances, and to maintain complete and accurate records.
Ascent Pharmaceuticals, Inc., a dosage form manufacturer, failed to make records available for inspection in a timely manner and shipped controlled substances without producing required documentation. On numerous occasions, the company did not accurately account for millions of dosages of oxycodone; methylphenidate, a common drug to treat attention deficit disorder (ADD); hydrocodone; amphetamines; and other controlled substances.
During the week of Oct. 2, DEA served two Orders to Show Cause, which set forth allegations against Quantum Commerce, LLC, a pharmaceutical distributor, and Shrieve Chemical Company, LLC, a chemical distributor.
Quantum Commerce, LLC, a pharmaceutical distributor, sold Schedule II through V drugs, including hydrocodone and oxycodone, to numerous pharmacies over a three-year period. The company failed to provide effective controls and procedures to guard against theft and diversion of controlled substances as required by a distributor.
Shrieve Chemical Company, LLC, a chemical distributor and importer, failed to maintain accurate and complete records of distribution and relabeling and packaging of controlled substances. This allegedly resulted in a significant discrepancy of GBL, a chemical used in gamma-butyrolactone (GHB) known as a date rape drug that can cause overdoses resulting in unconsciousness, seizures, slowed heart rate, severe respiratory depression, decreased body temperature, vomiting, nausea, coma, and death.
During the week of Oct. 16, DEA served an Immediate Suspension Order setting forth allegations against R&S Solutions, LLC, and an Order to Show Cause setting forth allegations against Atlantic Biologicals Corporation, both of which are drug distributors.
DEA suspended R&S Solutions, LLC’s registration because the company posed an imminent danger to public health and safety when it failed to account for more than one million dosage units of oxycodone and other Schedule II controlled substances. This is among the numerous occasions where the company failed to maintain controls against the diversion of these medications.
Atlantic Biologicals Corporation, one of the top opioid suppliers to numerous pharmacies in Houston, Texas, failed to report suspiciously-large orders of oxycodone and hydrocodone. Many of these pharmacies only stock the highest-strength opioids. Since 2017, the company failed to report any suspicious orders related to the Houston pharmacies or their opioid orders. The Order to Show Cause impacts the company’s DEA registration at both its North Carolina and Florida locations.
In the last year, DEA served 143 administrative actions against doctors, pharmacies, drug manufacturers, and drug distributors who were putting the public at risk by failing to handle controlled substances with the care required by federal law. DEA remains committed to holding registrants accountable to ensure that they fulfill the responsibilities entrusted to them and to prevent the diversion of controlled substances and harm to our communities.
An Order to Show Cause is an administrative proceeding that requires a DEA registrant to demonstrate why the registration should not be denied, revoked, or suspended before such action is taken. When served an Order to Show Cause, the registrant has the opportunity submit a corrective action plan for DEA review before a determination is made. An Immediate Suspension Order is an immediate suspension of a DEA registration when it is determined there is “imminent danger to the public health or safety.”
