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How to Survive a DEA Inspection Series: Compounding Controlled Substances

How to Survive a DEA Inspection Series: Compounding Controlled Substances

How to Survive a DEA Inspection Series: Compounding Controlled Substances

Carlos M. Aquino
Carlos M. Aquino
on behalf of International Academy Of Compounding Pharmacists

$70.00 $ 70.00 $ 70.00

$70.00 $ 70.00 $ 70.00

$ 70.00 $ 70.00 $ 70.00
$ 70.00 $ 70.00 $ 70.00
Normal Price: $70.00 $70.00

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Launch date: 10 Mar 2017
Expiry Date:

Last updated: 13 Mar 2017

Reference: 171783

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Description

Part Four of a Four-Part Series.
The responsibilities to enforced federal laws and regulations on the compounding of controlled substances by a pharmacy are placed on the Drug Enforcement Administration (DEA) through their Office of Diversion Control (Diversion).
Since the focus of any DEA compliance inspection is record-keeping, a compounding pharmacy will need to be prepared for that unannounced inspection that will focus on the purpose for compounding medications containing controlled substances and records required by DEA to be maintained by the pharmacy.
Attendees will familiarize themselves with the types of actions taken by DEA Diversion personnel at a compounding pharmacy. The focus of any compounding pharmacy is whether the pharmacy is compounding for a specific patient or group of patients needing a medication or the manufacturing of a controlled substance medication.

Objectives

Objectives
At the conclusion of this program, the pharmacist and technician attendee will be able to:
Identify the authority of Drug Enforcement Administration (DEA) Office of Diversion Control (Diversion) personnel to conduct an unannounced inspection at a compounding pharmacy and records that will be inspected or copied by their personnel.
Discuss administrative or civil actions taken by DEA for failure of a pharmacy to maintain compounding records for Schedules II through V prescriptions filled or compounded by the pharmacy.
Identify DEA record-keeping violations pertaining to: Inventory of Controlled Substances, Batch Records, Power of Attorney forms and other records required to be maintained by the compounding pharmacy.
Discuss the failure of specific DEA Diversion offices to understand the difference between anticipatory compounding versus manufacturing and how a compounding pharmacy can handle such issue when DEA enters the pharmacy.
Carlos M. Aquino

Author Information Play Video Bio

Carlos M. Aquino
on behalf of International Academy Of Compounding Pharmacists

Carlos M. Aquino Compliance Consultant and Founder - PharmaDiversion, LLC In January 2009, Carlos M. Aquino founded PharmaDiversion, LLC as a compliance consulting firm assisting DEA registrants who handle controlled substances and regulated chemicals, with compliance of federal laws and DEA regulations. This is done through a “Mock” audit and inspection equivalent to an authentic DEA Diversion on-site inspection. PharmaDiversion, LLC also provides in-service training for DEA registered manufacturers, distributors, importers/exporters, hospitals/clinics,...MoreIn January 2009, Carlos M. Aquino founded PharmaDiversion, LLC as a compliance consulting firm assisting DEA registrants who handle controlled substances and regulated chemicals, with compliance of federal laws and DEA regulations. This is done through a “Mock” audit and inspection equivalent to an authentic DEA Diversion on-site inspection. PharmaDiversion, LLC also provides in-service training for DEA registered manufacturers, distributors, importers/exporters, hospitals/clinics, analytical labs, researchers, pharmacies, pain management groups and practitioners on DEA requirements for handling of controlled substances and regulated chemical products. Consultant Carlos M. Aquino brings 36 years of experience on illicit and pharmaceutical controlled substances and regulated chemical products. This includes 12 years assigned to the Philadelphia DEA Diversion Office as a Diversion Investigator/Group Supervisor and 24 years with the Philadelphia Police Department as a street supervisor and an undercover agent investigating illegal distribution of illicit drugs and diversion of pharmaceutical drugs.

Current Accreditations

This course has been certified by or provided by the following Certified Organization/s:

  • Accreditation Council for Pharmacy Education (ACPE)
  • 1.00 Hours -
    Exam Pass Rate: 75
    -
    Reference: 0201-9999-15-133-H03-P/T

Faculty and Disclosures

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