Federal Controlled Substances Act: Ordering and Recordkeeping

* Director, Drug Information Group and Prior Authorization Services, Clinical Associate Professor, Department of Pharmacy Practice, University of Illinois at Chicago College of Pharmacy, Chicago, Illinois

* Director, Drug Information Group and Prior Authorization Services, Clinical Associate Professor, Department of Pharmacy Practice, University of Illinois at Chicago College of Pharmacy, Chicago, Illinois

This third of a 4-part series on key components of the Federal Controlled Substances Act will discuss ordering and recordkeeping requirements. Schedule I and II controlled substances may be ordered by filling out a Drug Enforcement Agency (DEA) Form 222 or by electronically completing the DEA Controlled Substance Ordering System (CSOS). 1 A sample Form 222 may be found on the DEA Diversion Web site at: http://www.deadiversion.usdoj.gov/pubs/manuals/pract/appendices/app_h/222.htm. 2 This official form is required for every distribution, purchase, or transfer of a Schedule II controlled substance. 1 In some instances, a medication may be switched from Schedule II to another Schedule at the federal level, but remain a Schedule II controlled substance at the state level. When this occurs, the stricter state law applies; many states may still require the use of Form 222 for any transaction involving a substance classified as Schedule II under the state law.

Official DEA order forms for Schedule II controlled substances must be maintained separately from other business records in the pharmacy. 1 These documents are available in books that contain 7 sets of forms. Generally, an individual pharmacy is given no more than 6 books at a time; however, more books may be allowed in specific situations. When ordering Schedule II medications, the number of packages, size of the package, and name of the item must be filled out completely on the form. Each form must be signed and dated by an authorized individual. For any individual pharmacy, there may be more than one person who is authorized to obtain and execute official DEA order forms for Schedule II medications. The pharmacy must grant a “power of attorney” to each authorized person. This power of attorney must be signed by the individual receiving authorization responsibilities and by the person who signed the most recent application for registration or renewal registration for the pharmacy.

Any sign of alteration on a DEA order form may be enough for a drug supplier to refuse a Schedule II controlled substances order. 1 A supplier may substitute identical drug products that differ in package size from those on the original order form. The only caveats to this substitution policy is that the actual quantity of Schedule II medication may not exceed the amount initially ordered and the National Drug Code (NDC) number must reflect that of the actual medication that was shipped to the purchaser.

Electronic ordering through the DEA CSOS is another option for obtaining controlled substances. 1 The CSOS allows for secure electronic transmission of controlled substance orders without supporting paper documentation. CSOS is currently the only acceptable way to electronically transmit Schedule II controlled substance orders. Users must obtain a digital certificate for ordering. These digital certificates may only be obtained by DEA registrants and individuals who are granted power of attorney by registrants. Each registrant must appoint a CSOS coordinator who acts as an agent regarding any issues related to digital certificates issued under the registrant’s DEA number. Digital certificates are valid until DEA registration expires or until the DEA Certification Authority is notified that the certificate should be revoked for various reasons. Records of electronic Schedule II orders must be maintained in an electronic format for 2 years. More information on CSOS, including how to enroll, may be obtained at the DEA E-Commerce Program Web site (http://www.deaecom.gov/).

For Schedules III to V controlled substances, the pharmacy must maintain receipts in a readily retrievable manner. 1 A receipt may be an invoice or packing slip where the pharmacy records both the date the Schedule III to V controlled substances were received and confirmation that the order is accurate. These receipts must also contain controlled substance name, dosage form, number of dosage units of the dosage form in each container, and number of containers ordered and received.

Pharmacies must keep an accurate record of every transaction involving a controlled substance (ie, purchasing, receiving, dispensing, or disposal). This allows for tracking of each controlled substance from initial manufacture to final dispensing to the patient or disposal. 1 A pharmacy must maintain these records for at least 2 years. Records involving Schedule II medications must be maintained separately from all other records. Records for Schedules III to V medications may either be maintained separately or be stored with other ordinary business records, but there must be some mechanism that allows for them to be “readily retrievable.” Table 1 summarizes records that must be maintained with regard to controlled substances.

Table 1.

Controlled substances records 1