NHA Controlled Substances

Controlled Substances Act (CSA) (1970)

What act regulated the manufacture, importation, possession, use, and distribution of controlled substances, and classifies controlled substances into five schedules?

C-II Refills

Are not permitted

Prescribing C-II medications for patients with a chronic established diagnosis.

For C-II, Prescribers can issue three 30 day supplies to create a 90 day supply. The date of issuance must be the same on all three supplies and have a “do not fill until/before” date on the second and third prescriptions.

C-III to C-IV refills

Can have up to 5 refills OR refills for up to 6 months from the date of issuance. Whichever comes up first.

C-V refills

Can be refilled as many times as authorized by Prescriber per federal law, but state laws may differ. (similar to regular OTC drugs)

C-II Prescription Expiration

No expiration per federal law, but may have expiration date per state law or company policy.

C-III to C-IV Prescription Expiration

Valid for 6 months from the date of issuance

C-V

No expiration per federal law, but may have expiration date per state law or company policy.

C-II Partial fills

permitted as long as the remainder is filled within 72 hours. IF the remainder isn’t filled within 72 hours, the remainder is void, and the prescriber must be notified

C-III to C-V Partial fills

Permitted with no time limit as long as the prescription is not expired.

Transferring C-II

Prohibited

Transferring C-III to C-V

Allow one time transfer between two pharmacies.

C-II Record maintenance

Records must be stored separately from all other prescription records

C-III to C-V Record maintnance

Must be stored separately or marked in the lower right corner with the letter “C” in red ink to store in the same file as non-controlled prescription records.

Maintenance of CS inventory: Initial

When issued a DEA registration, a pharmacy must take an initial inventory and record it.

Maintenance of CS inventory: Biannual

DEA registrants are required to take a new CS inventory at least every two years.

C-II transactions

May use DEA form 222 to document receiving or distributing a C-II into or out of inventory.

DEA CS ordering system (CSOS)

allows secure electronic ordering of C-II Controlled Substances without an accompanying DEA order form 222.

C-III to C-V transactions

all transactions can be recorded using invoices.

Disposing drugs using a reverse distributor

must be documented on a DEA form 222.

For returns or manufacturer recalls

CS must be delivered to the source of where it was purchased and documented on a DEA form 222.

Required information for Controlled Substance prescription

Patients: full name, address

Prescribers: name, address, DEA number, signature (by hand)

Drugs: name, strength, dose form, quantity prescribed

date issued

Directions for use

DEA form 41

reporting the destruction of CS

DEA form 104

104 reporting pharmacy closure or surrender of a pharmacy permit

DEA form 106

Reporting loss or theft of CS

DEA form 222

ordering C-I and C-II CS

DEA form 222a

ordering more DEA form 222

DEA form 224

applying for a DEA registration umber

DEA form 224a

DEA registration renewal

DEA registration must be renewed every

3 years

Pharmacies must hold DEA form 222 for at least

2 years