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Prescriptions; requirements clarification--Drug Enforcement Administration (DEA). Final rule
Federal Register
|May 11, 1991
Summary
This final rule clarifies controlled substance prescription requirements and allows partial filling of Schedule II prescriptions for terminally ill patients in hospice or home care. The use of medication order sheets for long-term care facilities was not adopted.
Area of Science:
- Pharmacology and Regulatory Affairs
- Healthcare Policy
Background:
- Current regulations govern the prescription and dispensing of controlled substances.
- Existing rules may not fully address the needs of terminally ill patients requiring controlled substances.
- Clarification on prescription requirements is necessary for consistent application.
Purpose of the Study:
- To amend regulations concerning controlled substance prescriptions.
- To extend the partial filling of Schedule II prescriptions to terminally ill patients.
- To clarify requirements for controlled substance prescriptions.
Main Methods:
- Final rule amendment to existing regulations (21 CFR 1306.05 and 1306.13).
- Review and consideration of public comments on proposed changes.
- Decision to defer the proposal regarding medication order sheets for separate consideration.
Main Results:
- Amendments to 21 CFR 1306.05 and 1306.13 are finalized.
- Partial filling of Schedule II prescriptions is now permitted for terminally ill patients in hospice or home care.
- The proposal for medication order sheets in Long Term Care Facilities is not adopted in this final rule.
Conclusions:
- The final rule enhances flexibility in dispensing Schedule II controlled substances for terminally ill patients.
- Regulatory clarity is provided for controlled substance prescription practices.
- Further regulatory action regarding medication order sheets will be announced separately.