How to Survive a DEA Inspection Series: Pharmacy Records and Security

Duration: 60 Minutes
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.
federal pharmacy law
Instructor: Carlos M. Aquino
Product ID: 500010
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). Since the focus of any DEA investigation is the legitimacy of a prescription, the initial target is the pharmacist who fulfilled the prescription. The pharmacy may be inspected in order to determine their handling of controlled substances purchased and dispensed as a prescription. The inspection targets record-keeping requirements, security of all controlled substances, and review of dispensed prescriptions.

Why Should you Attend:
This presentation talk about the extensive amount of information provided on the DEA regulation requirements for any pharmacy or pharmacist for controlled substances that are purchased and dispensed in a form of a prescription.

Objectives of the Presentation:
Class participants will familiarize themselves with federal laws and DEA regulations requirements for handling of Schedules II though V controlled substances in a pharmacy setting and the record-keeping and security responsibilities placed on the pharmacist. The presentation will:
  • Discuss the types of federal criminal and civil actions that can be imposed on a pharmacy pertaining to the purchase, sale, transfer, dispensing, destruction and theft or loss of Schedules II through V controlled substances.
  • Identify the responsibilities of DEA through their Diversion personnel to enforce federal laws and DEA regulations on the dispensing of controlled substances through a prescription.
  • Discuss the steps that a pharmacy can use to determine the legitimacy of a prescription and when the pharmacist would need to discuss the necessity for the prescription and the individual treatment plan leading to the prescribing of a narcotic as part of the patient care.
  • Discuss DEA record-keeping requirements pertaining to: Biennial Inventory; Executed or Voided DEA Form 222 and Invoices; Power of Attorney; Theft and Loss; Drug Destruction; and the Storage of Prescriptions.
  • Identify DEA security requirements pertaining to: Alarm Systems; Pharmacy Security; Hiring of Employees; Proper Drug Disposal; Prevention of Thefts and Losses; and other security issues.
  • Review DEA requirements pertaining to the filling of controlled substance prescriptions. This includes electronic prescriptions, a 90-day supply of a Schedule II drug, LTCF & hospice patient prescriptions, and prescriptions written for opioid dependency patients.
Who can Benefit:
  • Pharmacists
  • Pharmacy Students
  • Pharmacy Owners
  • Regulatory personnel including members of a state Board of Pharmacy or Department of Health.
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  • Get certification of attendance.
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Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Carlos M. Aquino brings 36 years of experience of handling illicit and pharmaceutical controlled substances and regulated chemicals. His testimonial ability, both in federal and state courts, is proof of his investigative experience and skills. Carlos has 12 years of experience working for Philadelphia DEA Diversion Group, which is responsible for initiating prosecutions of those DEA registrants who violate the federal Controlled Substances Act or DEA regulations pertaining to handling these substances. This has included eight years as a Diversion Investigator and four years as a Group Supervisor. During his time at the DEA, he performed numerous regulatory inspections of manufacturers, distributors, importers/exporters, physicians, researchers, and pharmacies in order to determine their compliance with the federal laws and DEA regulations pertaining to controlled substances in Schedules II through V and regulated chemicals.
In addition to the above, Carlos has over 20 years of experience working for various law enforcement agencies including the Philadelphia Police. Carlos has a BA in Criminal Justice and has taught numerous courses during his time at the DEA.He is skilled in interpreting the Controlled Substances Act (CSA) and the Code of Federal Regulations (CFR), assisting the pharmaceutical industry with compliance, and preparing and submitting Drug Enforcement Administration (DEA) Forms 41, 104, 106, 222, 236, 486.
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