Pharmacy Law CE Column

By Laura Carpenter, RPh, JD, attorney and pharmacist, founder Carpenter Law Firm PC

Controlled substance record-keeping: Dispensing or other disposition

Last month's law column discussed the records a pharmacy must keep to document how it receives controlled substances. This article will close the loop and discuss those records required by the Drug Enforcement Agency to document how controlled substances leave the pharmacy. Drugs may legally leave the pharmacy in only two ways - with a patient pursuant to a valid prescription or to another DEA registrant, such as another pharmacy, wholesaler or a prescriber. We will discuss the record-keeping requirements for when controlled substances are dispensed or otherwise disposed.

Prescription records

The most common way for a controlled substance to leave the pharmacy is when it is dispensed to a patient pursuant to a valid prescription. In this case, the prescription records will serve as the "outgoing" record. The DEA allows pharmacies three options for filing prescription records. If there is a conflict between federal and state requirements for filing prescriptions, DEA recognizes that the pharmacy must choose a filing system that would comply with both federal and state law.ⁱ

• Option 1: Three separate files: (1) Schedule II; (2) Schedule III, IV and V; and (3) legend drugs.
• Option 2: Two separate files: (1) Schedule II; (2) all other drugs, with a red "C" stamp.
• Option 3: Two separate files: (1) Schedule II-V controlled substances, with a red "C" on Schedules III, IV and V; and (2) legend drugs dispensed.

If a pharmacy has an electronic record-keeping system for prescriptions that permits identification by prescription number and retrieval of original documents by prescriber's name, patient's name, drug dispensed and date filled, then the requirements to mark the hard copy prescription with a red "C" is waived.

Records for other dispositions

Transfer records

Pharmacies must transfer Schedule III, IV and V controlled substances to or from other registrants using an invoice. This record must contain: (1) the name of the drug; (2) the dosage form; (3) the strength of the dosage unit; and (4) the number of dosage units per container. The transferring pharmacy must place its name, address and DEA registration number on the invoice and keep a copy of the invoice in its records.

DEA Form-222

In April's article, we discussed how the DEA Form-222 is used to order Schedule II controlled substances and to document receipt of those drugs.ⁱⁱ In addition to these "receiving" duties, the DEA Form-222 is used when a pharmacy disposes of Schedule II controlled substances in some way other than dispensing pursuant to a prescription. When transferring a Schedule II to another DEA registrant, the receiving party will fill out its own DEA Form-222, sending you copies 1 and 2. Your pharmacy will retain copy 2 and send copy 1 to the DEA. This is typically used when a controlled substance is sent to a reverse distributor for credit or disposal.

Inventory of drugs surrendered for disposal

Once a year, pharmacies may request DEA authorization to destroy damaged, outdated or otherwise unwanted controlled substances. The pharmacy must complete DEA Form-41, listing all drugs to be destroyed. In addition, the pharmacy must prepare a letter requesting permission to destroy the controlled substances, proposing a date and method of destruction, and listing the names of at least two people who will witness the destruction.

Instead of destroying the controlled substances, most pharmacies use a reverse distributor. The pharmacy will use a DEA Form-222 for Schedule II and a DEA Form-41 for Schedule III-V controlled substances. The DEA registered reverse distributor who will destroy the controlled substances is responsible for submitting a DEA Form-41 to DEA when the drugs have been destroyed. A DEA Form-41 should not be used to record the transfer of controlled substances between the pharmacy and the registered reverse distributor disposing the drugs.

Reporting theft or significant loss of controlled substances

The law requires that pharmacies report the theft or significant loss of controlled substances immediately upon discovery to the nearest DEA office and local police. Such a report is made on a DEA Form-106. The form may either be completed manually or submitted online through a secure connection via the Internet to DEA headquarters. The new interactive form is located at the Diversion Control Program's Web site at www.deadiversion.usdoj.gov. Remember to review and follow any company specific policies and procedures regarding reporting a theft or loss.

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