DEA "Closed System" Requirements

Description

U.S. Drug Enforcement Administration (DEA) “closed system” requirements call for all legitimate handlers of controlled substances to register and account for all distributions under the Controlled Substances Act of 1973 (CSA) and the Secure and Responsible Drug Disposal Act of 2010 (SRDDA) (DEA, 2006). In a closed system, record-keeping is required for controlled substances from the creation to disposal, thus keeping controlled substances within the system. Pharmaceutical controlled substances found outside this closed system are said to have been diverted (Brushwood, 2006).

Objective(s)

To regulate and track the distribution of prescription drugs containing controlled substances with the goal of limiting availability for diversion

Typical Elements

Under the CSA, registration and accounting of controlled substances is required for all manufacturers, distributers, hospitals, physicians, pharmacists, researchers, and others that handle controlled drugs (DEA, 2006). Under a closed system:

  • Authorized personnel must account for controlled substances at every phase of the process, from production through prescription, distribution, and return (as needed).
  • All individuals and organizations that manufacture, distribute, or handle controlled substances must register with the DEA (Yeh, 2012). The DEA must determine that the registration is “consistent with the public interest” (Yeh, 2012, p. 6), using such criteria as the expected effects on public health and safety, and registrant compliance with state and federal laws. The DEA can deny, suspend, or revoke registrations.
  • Individuals and organizations whose state licenses or registrations are revoked must surrender their DEA registration or face civil or criminal penalties. The “majority of investigations into possible violations of controlled substance laws are carried out by state authorities,” (DEA, 2006, p. 4); the DEA relies on state actions to determine whether to revoke registration.
  • End users (patients) are not required to register, as they are not part of the closed system (Yeh, 2012).
  • Registrants are required, for at least two years, to maintain accurate records and detailed inventories of all controlled substances manufactured, received, delivered, sold, stored, dispensed, or otherwise disposed of (Yeh, 2012).
  • Manufacturers must maintain records of all controlled substance shipments and must receive a special order form from registered purchasers before shipping Schedule I or II substances (Yeh, 2012).
  • Manufacturers must forward to the DEA filled paper orders for Schedule I or II substances within 30 days and filled electronic orders within 2 days (Yeh, 2012).
  • Manufacturers must complete Automated Reports and Consolidated Orders System reports for all shipments of Schedule I or II substances and certain Schedule III or IV substances (Yeh, 2012).
  • Registered Internet pharmacies must submit monthly reports to the DEA on the total amounts of dispensed controlled substances (Yeh, 2012).
  • Schedule I substances cannot be prescribed or dispensed to patients (Yeh, 2012).
  • Schedule II–V substances can be prescribed and dispensed to patients following DEA regulations for communicating prescriptions to pharmacies (Yeh, 2012).
  • The CSA authorizes the DEA to limit the annual production of Schedule I or II controlled substances (Yeh, 2012).
  • The CSA requires DEA registrants to “provide effective controls and procedures to guard against theft and diversion of controlled substances” and to be prepared to alter their security measures should a controlled substance change schedule classification (Yeh, 2012, p. 15).
  • DEA registrants can dispose of unwanted controlled substances in one of three ways (Yeh, 2012, p. 16):
    • “The distributor or dispenser may return the controlled substance to the pharmaceutical manufacturer who accepts returns of outdated or damaged controlled substances.
    • “The distributor, dispenser, or manufacturer may itself dispose of the controlled substances under procedures specified by federal regulation.
    • “The distributor, dispenser, or manufacturer may transfer the controlled substances to a ‘reverse distributor’ to take custody of the controlled substances for the purpose of returning them to the manufacturer or arranging for their disposal.”

The SRDDA expands the disposal options for DEA registrants and gives end users a legal mechanism to safely and securely dispose of controlled substances. Disposal options include takeback events, mail-back events, and authorized collection receptacles (DEA, 2012). Under the SRDDA:

  • Manufacturers, distributors, and pharmacies are authorized to voluntarily conduct mail-back events and maintain collection receptacles for use by the general public (the end users).
  • Law enforcement agencies have the authority to dispose of controlled substances, hold events, and maintain collection receptacles.
  • Registrants are “prohibited from manufacturing, distributing, or dispensing controlled substances not authorized under their specific registration,” under penalty of fines, imprisonment, or both (Yeh, 2012, p. 14).
  • Registrants who improperly dispense or request authorized controlled substances can be subject to U.S. Attorney General-ordered injunctions to cease improper operations or to declaratory judgments terminating their registration (Yeh, 2012).

Populations

Pharmaceutical companies, shipping companies, pharmacies, physicians, hospitals, consumers

Outcomes

No outcome data have been found regarding the role of DEA “closed system” requirements in preventing the nonmedical use of prescription drugs and/or its consequences.

Guidelines

A Security Outline of the Controlled Substances Act of 1970. 

Chemical Handler’s Manual: A Guide to Chemical Control Regulations. 

Pharmacist’s Manual: An Informational Outline of the Controlled Substances Act. 

Practitioner’s Manual: An Informational Outline of the Controlled Substances Act. 

Acknowledged by

No acknowledgements have been found regarding the role of DEA “closed system” requirements in preventing the nonmedical use of prescription drugs and/or its consequences.

References

Brushwood, D.  B. (2006, May 31). A Balanced Approach to Chronic Pain Management: The Closed System of Controlled Substance Distribution. Retrieved from https://www.medscape.org/viewarticle/532074_2

U.S. Drug Enforcement Administration. (2006). Practitioner’s manual: An informational outline of the Controlled Substances Act. Washington, DC: U.S. Department of Justice. Retrieved from http://www.deadiversion.usdoj.gov/pubs/manuals/pract/pract_manual012508.pdf

U.S. Drug Enforcement Administration. (2012). Disposal of controlled substances: Notice of proposed rule making. Federal Register, 77(246). Retrieved from http://www.deadiversion.usdoj.gov/fed_regs/rules/2012/fr1221_8.htm

Yeh, B. T. (2012). The Controlled Substances Act: Regulatory requirements. Washington, DC: Congressional Research Service. Retrieved from https://fas.org/sgp/crs/misc/RL34635.pdf