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How to Survive a DEA Inspection Series Pharmacy Records and Security
The public media has been reporting the abuse of narcotic drugs prescribed for pain management with its focus on the legitimacy of prescriptions and the dispensing by a pharmacist. Both federal and state regulations have placed the responsibilities on the physician who wrote the prescription and the pharmacist who filled the prescription.
Today's pharmacists will need to familiarize themselves with the stringent laws and regulations enforced by the Drug Enforcement Administration (DEA) through their Office of Diversion Control (Diversion).
Question And Answers
1. What is the definition of the prescription?
- A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.
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2. What are the laws and regulation with regards to handling of schedules I to V Controlled Substances?
- Title 21, United States Codes - Section 801 et seq. (Controlled Substances Act 1970) is the LAW, Title 21, Code of Federal Regulations - Part 1300 to End is the REGULATIONS, Title 21, United States Codes - Section 829 – Prescriptions, Title 21, Code of Federal Regulations - Section 1306 – Prescriptions
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3. How to maintain record and inventories as per Title CFR1304.04?
- Every inventory and other records required to be kept under this part must be kept by the registrant and be available, for at least 2 years from the date of such inventory or records, for inspection and copying by authorized employee of the administration.
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4. What is the purpose of CSOS?
- Eliminate the cost of mailing order requisition, Reduce the time to get you the Schedule II orders
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5. What are the information to be included in DEA form 106?
- Drug, Quantity, Strength, NDC number, Explanation of Theft/Loss, Police department you reported Theft/Loss, Number of previous Theft/Loss.
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