DEA Compliance
The
Controlled Substances Act (CSA), Title II and Title III of the Comprehensive
Drug Abuse Prevention and Control Act of 1970, is the legal foundation of the
U.S. Government's fight against the abuse of drugs and other substances. This
law is a consolidation of numerous laws regulating the manufacture and
distribution of narcotics, stimulants, depressants, hallucinogens, anabolic
steroids, and chemicals used in the illicit production of controlled
substances.
Many narcotics,
depressants and stimulants manufactured for legitimate medical use are subject
to abuse and have therefore been brought under legal control. The goal of
controls is to ensure that these "controlled substances" are readily available
for medical use, while preventing their distribution for illicit sale and abuse.
Under federal law, all
businesses that manufacture or distribute controlled drugs, all health
professionals entitled to dispense, administer or prescribe them, and all
pharmacies entitled to fill prescriptions, must register with the DEA.
Registrants must comply with a series of regulatory requirements relating to
drug security, records accountability, and adherence to
standards.
CompliaPharm guides clients in meeting DEA requirements
for the manufacture and distribution of controlled substances through the
following services:
- Diversion risk assessments
- Development of policies and SOPs
- Controlled substance audits
- Receipt
- Storage
- Distribution
- Records
- Traceability
- Returns
- Inventory
count
- Employee training
- Receipt
- Freight forwarding facility audits
- Controlled substance sampling program assessments
- ARCOS
reporting guidance
- Manufacturers of bulk and/or dosage form controlled
substances
- Distributors of bulk and/or dosage form controlled substances
- Manufacturers of bulk and/or dosage form controlled
substances
- Manufacturing reconciliation processes