Legitimate Medical Purpose
A prescription for a controlled substance must be for a legitimate medical purpose and issued by a practitioner acting in their usual course of practice. Pharmacists have a corresponding responsibility to ensure the prescription's legitimacy.
Who Can Issue a Prescription:
According to 21 CFR 1306.03, a prescription can only be issued by:
- Practitioners authorized by their jurisdiction.
- Those registered with the DEA or exempt from registration.
- Agents or employees of registered institutions, provided specific additional requirements are met.
What is a Prescription
Per 21 CFR 1300.01(b), a prescription is an order for medication dispensed to an ultimate user (patient), but not for immediate administration in a hospital setting.
Format of Prescription
- Schedule II substances: Can be written or electronic, with oral prescriptions allowed in certain emergencies.
- Schedule III-V substances: Can be written, electronic, or oral.
All prescriptions must be dated and signed on the issue date and include:
- Patient's full name and address
- Practitioner's full name, address, and DEA number
- Drug name, strength, dosage form
- Quantity prescribed
- Directions for use
- Number of refills (if any)
Accountability and Requirements
The practitioner is responsible for ensuring the prescription complies with all laws and regulations, federal and state alike. Paper prescriptions must be written in ink, indelible pencil, or printed and manually signed by the practitioner.
Responsibilities of the Pharmacist
The pharmacist must verify that the prescription was issued for a legitimate medical purpose. Both the issuer and the person filling an illegitimate prescription may face legal penalties.
Practitioners must not issue prescriptions to obtain controlled substances for general dispensing to patients.
This highlights the key points for practitioners and pharmacists in issuing and filling prescriptions for controlled substances according to DEA guidelines.
CLICK HERE to read the DEA Practitioners Manual - Part 11: Security
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