Controlled Substances and Federal/State Drug Law Compliance
Controlled-substance items combine the federal Controlled Substances Act with Colorado's PDMP and opioid rules. Expect questions on order forms, prescription limits, red flags, and reporting.
Registration and handling
The DEA registration is site-specific; a Colorado pharmacy does not obtain a separate state controlled-substance registration, but its Board license and DEA registration must both be current. Schedule II stock is ordered on DEA Form 222 or through CSOS; CIII-V on invoices. Invoices and 222 forms are retained for at least two years. A biennial inventory is required, plus inventories at change of pharmacist-in-charge or ownership; CII counts must be exact. Controlled substances are stored in a securely locked, substantially constructed cabinet or dispersed within a locked area, with access limited.
Prescription rules
- CII: no refills; multiple prescriptions totaling up to 90 days may be filled if the prescriber specifies earliest fill dates; partial fills permitted within federal time limits.
- CIII-V: five refills or six months, whichever comes first.
- Corresponding responsibility: the pharmacist must resolve red flags-early refills, multiple prescribers, long distance, cash payment, escalating quantities-before dispensing. Document what was checked and what the prescriber said.
- PDMP: dispensers report each controlled-substance dispensing to the Colorado PDMP by the next business day and correct errors. Prescribers must query the PDMP before prescribing opioids and benzodiazepines; pharmacists should query whenever red flags appear.
- Colorado opioid limits: initial opioid prescriptions for acute pain are limited to a short supply, with statutory exceptions; verify documentation when a prescription exceeds the limit.
- Naloxone: may be dispensed without a patient-specific prescription under standing order.
Loss and theft
Significant loss or theft is reported to the DEA field office on Form 106 and to the Board promptly; the pharmacy also performs an accountability review.
Worked example
A new patient presents oxycodone 30 mg #120 with a 30-day supply, pays cash, lives 150 miles away, and has no history at the pharmacy. The pharmacist queries the PDMP, finds three prescribers and two pharmacies in 60 days, calls the prescriber, and documents the conversation. Dispensing without resolution would violate corresponding responsibility even though the prescription is facially valid.
Traps
- Refilling a CII.
- Assuming an electronic CII is invalid.
- Missing the next-business-day PDMP deadline.
- Failing to report a theft.
- Filling a facially valid prescription without resolving red flags.