Regulatory Compliance & Standards Flashcards
7 cards from real ADM practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Regulatory Compliance & Standards flashcards as text
Under the Ryan Haight Online Pharmacy Consumer Protection Act, how many in-person medical evaluations must a prescriber conduct before prescribing controlled substances via telemedicine?
Answer: At least one in-person evaluation
The Ryan Haight Act requires at least one in-person medical evaluation before a practitioner may prescribe controlled substances via the internet.
Which federal agency oversees the Drug Addiction Treatment Act of 2000 (DATA 2000) waiver program for office-based buprenorphine treatment?
Answer: Substance Abuse and Mental Health Services Administration (SAMHSA)
SAMHSA oversees the DATA 2000 waiver (now largely eliminated by the SUPPORT Act) that allowed qualifying practitioners to prescribe buprenorphine for OUD in office-based settings.
The SUPPORT for Patients and Communities Act of 2018 made which major change to buprenorphine prescribing?
Answer: Allowed nurse practitioners and physician assistants to prescribe buprenorphine for OUD
The SUPPORT Act permanently authorized nurse practitioners and physician assistants to obtain DATA waivers and prescribe buprenorphine for OUD treatment.
A patient on methadone maintenance at an OTP misses three consecutive days of dosing. According to federal regulations, what must the OTP do before reinstating the patient?
Answer: Reassess the patient clinically before restarting, potentially at a lower dose
Federal OTP regulations require clinical reassessment after significant medication gaps to determine a safe reinduction dose and minimize overdose risk.
Under 42 CFR Part 2, which of the following is NOT a circumstance that permits disclosure of substance use disorder treatment records without patient consent?
Answer: A subpoena issued by the prosecutor in a criminal investigation
A standard prosecutor's subpoena alone does not authorize disclosure under 42 CFR Part 2; a court order meeting specific criteria is required for most non-emergency disclosures.
Which of the following best describes the Consolidated Appropriations Act of 2023 changes to buprenorphine prescribing?
Answer: Eliminated the X-waiver requirement entirely, allowing any DEA-registered practitioner to prescribe buprenorphine for OUD
The Consolidated Appropriations Act of 2023 eliminated the X-waiver requirement, allowing any DEA-registered practitioner with Schedule III authority to prescribe buprenorphine for OUD.
Which ASAM level of care corresponds to a medically managed intensive inpatient program (Level 4)?
Answer: A hospital-based inpatient program with 24-hour physician management
ASAM Level 4 (Medically Managed Intensive Inpatient) requires 24-hour physician-managed care, typically provided in a hospital or hospital-equivalent setting.