Certification
DEA-Licensed CDMOs
Compare CDMOs with DEA registration for controlled substance manufacturing. Filter by schedule classification, dosage form, and security infrastructure.
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About DEA Licensing for CDMOs
DEA (Drug Enforcement Administration) registration is required for any facility that manufactures, distributes, or dispenses controlled substances in the United States. Controlled substances are classified into Schedules I-V based on their abuse potential. CDMOs manufacturing drugs containing opioids, benzodiazepines, stimulants, barbiturates, or other controlled substances must hold DEA registration and comply with strict security and record-keeping requirements.
DEA-registered CDMOs must maintain: vault or cage storage for controlled substances, electronic access logging, perpetual inventory reconciliation, annual DEA production quotas, waste disposal documentation, and employee background checks. The operational overhead of DEA compliance is significant, which limits the number of CDMOs willing and able to handle controlled substances.
Frequently Asked Questions
Which pharmaceutical products require DEA licensing?+
Products containing: opioids (Schedule II -- morphine, oxycodone, fentanyl), stimulants (Schedule II -- amphetamine, methylphenidate), barbiturates (Schedule II-IV depending on type), benzodiazepines (Schedule IV -- diazepam, alprazolam), certain sleep aids (Schedule IV -- zolpidem), and some cough suppressants (Schedule V -- codeine-containing products). CDMOs must hold DEA registration at the specific schedule levels they intend to manufacture.
What security measures do DEA-licensed CDMOs require?+
DEA requirements include: physical security (vault storage, access controls, alarm systems), inventory controls (perpetual inventory with reconciliation), production quotas (annual allocation from DEA based on legitimate medical need), chain-of-custody documentation for every gram of controlled substance, employee screening (background checks for all personnel handling controlled substances), and waste destruction documentation (witnessed destruction with records).
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