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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...

Security measures that registered practitioners must take, as well as employment rules regarding individuals who have access to controlled substances. Let's break down some of the key points. DEA Security Requirements: Effective Controls: All registrants, including practitioners, must establish effective controls and procedures to prevent the theft and diversion of controlled substances. This is as per 21 CFR 1301.71(a). Storage: If controlled substances are kept in a DEA-registered office, they must be stored in a securely locked and substantially constructed cabinet, as per 21 CFR 1301.75(b). Employment Waivers: Restrictions: According to 21 CFR 1301.76(a), practitioners cannot employ individuals who have...

DEA Practitioner’s Manual: Schedule III-V Controlled Substances Federal regulations in the United States governing the prescribing, dispensing, and refilling of Schedule II, III, IV, and V controlled substances according to the DEA Practitioner’s Manual and relevant parts of the Code of Federal Regulations (CFR) and United States Code (U.S.C.). For Schedule II substances: Written or electronic prescriptions are mandatory, with oral prescriptions permitted only in emergency situations. Refilling is prohibited. Multiple prescriptions are allowed up to a 90-day supply under certain conditions. Faxing a prescription is allowed, but the original must be verified. Emergency oral prescriptions have specific rules, including...

DEA Practitioner's Manual: Schedule II Controlled Substances Federal regulations and guidelines surrounding Schedule II controlled substances in the United States, covering topics like prescription requirements, refills, issuance of multiple prescriptions, facsimile prescriptions, emergency prescribing, and partial filling. These regulations are enforced by the Drug Enforcement Administration (DEA) and are meant to balance the need for access to these medications for legitimate medical use with the requirement to minimize the risk of abuse and diversion. The guidelines specify: Prescriptions must be written and signed by a qualified practitioner or meet DEA requirements for electronic prescriptions. Schedule II prescriptions can't be refilled....

The DEA Practitioner's Manual outlines specific recordkeeping requirements for practitioners who deal with controlled substances. The main points regarding these requirements are as follows: General Recordkeeping: Complete and Accurate Records: Practitioners must keep up-to-date, complete, and accurate records of each controlled substance they purchase, receive, sell, store, distribute, dispense, or otherwise handle. This is laid out in 21 CFR 1304.21(a). Accountability: These records serve to trace controlled substances throughout their lifecycle, from manufacturing to final dispensing, helping to minimize the potential for diversion. Retention Period: All records concerning controlled substances must be kept for at least two years for inspection...