Controlled Substances Regulations

How are Controlled Substances classified (Schedules I through V)?

Based on their accepted medical use and their potential for abuse/dependence. Schedule I has the highest abuse potential (no accepted medical use); Schedule V has the lowest.

What defines a Schedule I (C-I) drug, and what are common examples?

High abuse potential, no accepted medical use in the US. Examples: Heroin, LSD, Marijuana, Ecstasy.

What are the refill rules and expiration limits for a Schedule II (C-II) prescription?

Zero refills allowed. Under federal law, the original prescription does not have a set expiration date, but it must be filled within a "reasonable time" (though many states set a 30- to 90-day limit).

What are the refill rules and expiration limits for Schedule III (C-III) and Schedule IV (C-IV) prescriptions?

Maximum of 5 refills within 6 months from the date written (whichever comes first).

Can a Schedule II (C-II) prescription be taken as a verbal/phone order?

No, with a rare exception for immediate emergencies (and the prescriber must provide a signed, written, or electronic follow-up script within 7 days).

What do the first two letters of a practitioner's DEA number signify?

• 1st Letter: Type of prescriber (A, B, F, or G for hospital/clinic/MD/DO; M for Mid-level practitioner like an NP or PA).

• 2nd Letter: The first letter of the prescriber's last name.

What is the step-by-step formula to validate a DEA number using its 7 digits?

• Add the 1st, 3rd, and 5th digits.

• Add the 2nd, 4th, and 6th digits, then multiply that sum by 2.

• Add those two totals together. The last digit of this final sum must match the 7th digit of the DEA number.

What is DEA Form 222 used for, and how long must records be kept?

Used for the ordering, purchasing, and transferring of Schedule I and Schedule II controlled substances. Records must be kept for 2 years.

What is DEA Form 106 used for?

To report the significant theft or loss of any controlled substance. The pharmacy must notify the DEA within 1 business day of discovery.

What is DEA Form 41 used for?

To document the destruction of controlled substances (e.g., expired or damaged medications).

How often must a pharmacy perform a complete inventory of all controlled substances?

Biennially (every 2 years). (Note: C-IIs require an exact physical count; C-III through C-V can be estimated unless the bottle holds more than 1,000 tablets).

What are the federal sales limits for Pseudoephedrine (Sudafed)?

• Daily limit: 3.6 grams per purchaser.

• 30-day limit: 9.0 grams per purchaser.

• Mail-order 30-day limit: 7.5 grams.

What are the storage and record-keeping requirements for Pseudoephedrine sales?

Must be stored behind the pharmacy counter or in a locked cabinet. Sales must be logged in a written or electronic logbook, and records must be kept for 2 years.