Are there specific Federal record keeping requirements for office-based opioid therapy?
DEA record keeping requirements for office-based opioid therapy go beyond the Schedule III record keeping requirements. According to DEA: • Practitioners must keep records (including an inventory that accounts for amounts received and amounts dispensed) for all controlled substances dispensed, including Subutex and Suboxone (21 PART 1304.03[b]). In some cases, patients return to the prescribing physician with their filled Subutex or Suboxone prescriptions so that the practitioner can monitor the induction process. While it is acceptable for the patient to return to the practitioner with their filled prescription supplies, practitioners shall not store and dispense controlled substances that are the result of filled patient prescriptions. • Practitioners must keep records for controlled substances prescribed and dispensed to patients for maintenance or detoxification treatment (21 CFR Section 1304.03[c]). Many practitioners comply with this requirement by creating a log that identifies
DEA record keeping requirements for office-based opioid therapy go beyond the Schedule III record keeping requirements. According to DEA: • Practitioners must keep records (including an inventory that accounts for amounts received and amounts dispensed) for all controlled substances dispensed, including Subutex and Suboxone or approved generic versions of these products (21 PART 1304.03[b]). In some cases, patients return to the prescribing physician with their filled Subutex or Suboxone or approved generic versions of these products prescriptions so that the practitioner can monitor the induction process. While it is acceptable for the patient to return to the practitioner with their filled prescription supplies, practitioners shall not store and dispense controlled substances that are the result of filled patient prescriptions. • Practitioners must keep records for controlled substances prescribed and dispensed to patients for maintenance or detoxification treatment (21 CFR Section 1
