Controlled Substances and DEA Regulations Flashcards

Which analgesic was rescheduled from Schedule III to Schedule II in 2014 by the DEA?

Answer: Hydrocodone combination products (e.g., Vicodin)

In October 2014, the DEA reclassified hydrocodone combination products (HCPs) from Schedule III to Schedule II due to high abuse and diversion rates, eliminating phone-in and refill privileges.

Under DATA 2000 (Drug Addiction Treatment Act), specially waivered physicians may prescribe which medication in an office-based setting for opioid use disorder?

Answer: Buprenorphine (Suboxone/Subutex)

DATA 2000 created a waiver system allowing qualified practitioners to prescribe buprenorphine (Schedule III) for opioid use disorder in office-based settings, unlike methadone which requires licensed opioid treatment programs (OTPs).

Electronic prescriptions for controlled substances (EPCS) are permitted under which federal regulation?

Answer: DEA Interim Final Rule of 2010 (21 CFR Parts 1300, 1304–1306, 1311)

DEA's 2010 Interim Final Rule (codified in 21 CFR Part 1311) established requirements for electronic prescriptions for controlled substances (EPCS), including identity proofing, two-factor authentication, and audit trails.

Naloxone (Narcan) dispensing under standing orders and pharmacist-initiated protocols is important because:

Answer: It allows rapid community access to opioid overdose reversal without a patient-specific prescription

Naloxone standing orders allow pharmacists to dispense naloxone to patients/caregivers without an individual prescription, dramatically increasing community access for opioid overdose reversal.

What distinguishes a Schedule II prescription with a 'do not fill until' date (post-dating) from a standard CII prescription?

Answer: They are permissible; the prescription is valid but cannot be filled before the indicated date — it still expires 90 days after the written date

DEA allows prescribers to write a CII prescription with an instruction not to fill until a future date, giving the patient a supply without requiring multiple office visits. The 90-day validity still applies from the written date.

A DEA Form 222 has an error in the 'number of packages' column. The pharmacy should:

Answer: Destroy the form and use a new DEA Form 222

DEA Form 222 cannot be altered, corrected, or erased. Any error renders the form void; a new form must be used. The voided form should be retained on file.