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How to Survive a DEA How to Survive a DEA Inspection Series: Inspection Series: “Maintaining Your Pharmacy’s “Maintaining Your Pharmacy’s DEA Compliance” DEA Compliance” Independent Pharmacy Alliance of Independent Pharmacy Alliance of America Inc. America Inc. (IPA) (IPA) June 24, 2015 June 24, 2015 1
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Page 1: How to Survive a DEA Inspection Series: “Maintaining Your Pharmacy’s DEA Compliance” Independent Pharmacy Alliance of America Inc. (IPA) June 24, 2015.

How to Survive a DEA How to Survive a DEA Inspection Series:Inspection Series:

“Maintaining Your “Maintaining Your Pharmacy’s DEA Compliance” Pharmacy’s DEA Compliance”

Independent Pharmacy Alliance of Independent Pharmacy Alliance of America Inc.America Inc.

(IPA) (IPA)

June 24, 2015June 24, 2015 1

Page 2: How to Survive a DEA Inspection Series: “Maintaining Your Pharmacy’s DEA Compliance” Independent Pharmacy Alliance of America Inc. (IPA) June 24, 2015.

James R. Schiffer, Esq.James R. Schiffer, Esq.Member of Member of

Allegaert Berger & Vogel LLPAllegaert Berger & Vogel LLPNew York, NYNew York, NY

Carlos M. AquinoCarlos M. AquinoCompliance ConsultantCompliance ConsultantPharmaDiversion, LLCPharmaDiversion, LLC

Media, PAMedia, PA

Individuals may not modify or use this presentation without Individuals may not modify or use this presentation without the expressed written consent of PharmaDiversion, LLC.the expressed written consent of PharmaDiversion, LLC.

2

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PHARMADIVERSIONPHARMADIVERSIONDISCLAIMERSDISCLAIMERS

- We Do Not Represent DEA- We Do Not Represent DEA- We Do Not Speak on Behalf of - We Do Not Speak on Behalf of

DEADEA- We Suggest You Read the - We Suggest You Read the

Mentioned Federal Laws and Mentioned Federal Laws and RegulationsRegulations

www.deadiversion.uswww.deadiversion.usdoj.govdoj.gov 3

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DISCLAIMERSDISCLAIMERS

“Neither Counsel Schiffer “Neither Counsel Schiffer or Consultant Aquino have or Consultant Aquino have any affiliation or financial any affiliation or financial relationship with IPA or relationship with IPA or

any sponsor of this any sponsor of this program.”program.”

4

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My ExperienceMy Experience

24 Years with Philadelphia Police24 Years with Philadelphia Police(Last 10 years assigned to DEA Task (Last 10 years assigned to DEA Task

Force)Force)

12 Years with PFD DEA Diversion12 Years with PFD DEA Diversion(8 as an Investigator & 4 as a (8 as an Investigator & 4 as a

Supervisor)Supervisor)

4 Years with PharmaDiversion LLC 4 Years with PharmaDiversion LLC as a DEA Compliance Consultantas a DEA Compliance Consultant

2 Years with Pharma Compliance 2 Years with Pharma Compliance Group LLCGroup LLC

as a DEA Compliance Consultantas a DEA Compliance Consultant

Back with PharmaDiversion LLCBack with PharmaDiversion LLC

5

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LEARNING OBJECTIVESLEARNING OBJECTIVES

- Criminal & Civil Actions- Criminal & Civil Actions- Role of DEA Office of Diversion - Role of DEA Office of Diversion

ControlControl- Record-Keeping Requirements- Record-Keeping Requirements

- Security Requirements- Security Requirements- Prescriptions Issues- Prescriptions Issues

- Records for DEA Audit - Records for DEA Audit- Use of CSOS- Use of CSOS

6

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www.deadiversion.uswww.deadiversion.usdoj.govdoj.gov

(Answer for Restless Night)(Answer for Restless Night)

INFO & LEGAL RESOURCESINFO & LEGAL RESOURCES

- Title 21 Regulations & Codified - Title 21 Regulations & Codified CSACSA

- Questions & Answers- Questions & Answers- Significant Document Guidance- Significant Document Guidance

- Pharmacist’s Manual 2010- Pharmacist’s Manual 2010 7

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DRUG ENFORCEMENT ADMINISTRATION DRUG ENFORCEMENT ADMINISTRATION (DEA) (DEA)

OFFICE OF DIVERSION OFFICE OF DIVERSION CONTROLCONTROL

Responsible to Responsible to PreventPrevent, , DetectDetect, and , and

InvestigateInvestigate Diversion of Pharmaceutical Diversion of Pharmaceutical Controlled Substances & Regulated Controlled Substances & Regulated

Chemicals While Ensuring an Adequate Chemicals While Ensuring an Adequate Supply for Legitimate Medical and Scientific Supply for Legitimate Medical and Scientific

PurposesPurposes

- - Enforcing the Federal Laws & RegulationsEnforcing the Federal Laws & Regulations relating to Schedules I to V Controlled relating to Schedules I to V Controlled Substances and Regulated Chemicals Substances and Regulated Chemicals

(Tactical Diversion Squad)(Tactical Diversion Squad)

- - On-Site Audits and InspectionsOn-Site Audits and Inspections of of Controlled Substances and Regulated Controlled Substances and Regulated

Chemicals (Diversion Compliance Group)Chemicals (Diversion Compliance Group)

8

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ACTIONS BY ACTIONS BY DEADEA

- Criminal Investigation- Criminal Investigation

- Civil Action through USAO- Civil Action through USAO

- Administrative Actions- Administrative Actions

- Referral to State - Referral to State Regulatory AgencyRegulatory Agency 9

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DEADEAADMINISTRATIVE ACTIONSADMINISTRATIVE ACTIONS

- Letter of Admonition- Letter of Admonition- Memorandum of - Memorandum of

UnderstandingUnderstanding- Voluntary Surrender of - Voluntary Surrender of

RegistrationRegistration(Never Surrender – Consult Attorney)(Never Surrender – Consult Attorney)

- Order To Show Cause- Order To Show Cause- Immediate Suspension- Immediate Suspension

- Revocation of - Revocation of RegistrationRegistration

10

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DEFINITION OF A PRESCRIPTIONDEFINITION OF A PRESCRIPTION

“A prescription for a controlled “A prescription for a controlled substance to be effective must substance to be effective must

be issued for a be issued for a legitimate legitimate medical purpose medical purpose by an individual by an individual practitioner acting in the practitioner acting in the usual usual

course course of his of his professional professional practicepractice. The responsibility for . The responsibility for

the proper prescribing and the proper prescribing and dispensing of controlled dispensing of controlled substances is upon the substances is upon the

prescribing practitioner,prescribing practitioner,11

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but a but a corresponding responsibility corresponding responsibility rests with the pharmacist who fills rests with the pharmacist who fills

the prescription. An order purporting the prescription. An order purporting to be a prescription issued to be a prescription issued notnot in the in the

usual course of professional usual course of professional treatment or in legitimate and treatment or in legitimate and authorized research is not a authorized research is not a

prescription within the meaning and prescription within the meaning and intent of section 309 of the Act (intent of section 309 of the Act (

21 U.S.C. 829) and the person ) and the person knowingly filling such a purported knowingly filling such a purported prescription, as well as the person prescription, as well as the person issuing it, shall be subject to the issuing it, shall be subject to the

penalties provided for violations of penalties provided for violations of the provisions of law relating to the provisions of law relating to

controlled substances.”controlled substances.”

Title 21, Code of Federal Regulations Section Title 21, Code of Federal Regulations Section 1306.04(a)1306.04(a)

12

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CSA LAWCSA LAW&&

CFR CFR REGULATIONREGULATION

SS 13

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Title 21, United States Title 21, United States Codes (Controlled Codes (Controlled

Substances Act 1970)Substances Act 1970)is the is the LAWLAW

Title 21, Code of Federal Title 21, Code of Federal Regulations Part 1300 to Regulations Part 1300 to

EndEndis the is the REGULATIONSREGULATIONS

14

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Title 21, United States Title 21, United States Codes Codes

Section 829Section 829 – – PrescriptionsPrescriptions

Title 21, Code of Federal Title 21, Code of Federal Regulations Regulations

Section 1306Section 1306 - - PrescriptionsPrescriptions

15

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Its Time to Its Time to ScareScare Your Your Checkbook Checkbook

!!!!16

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CIVIL ACTIONSCIVIL ACTIONS

Title 21, United States Title 21, United States CodesCodes

Section 842. Prohibited Section 842. Prohibited Acts BActs B

a) a)

Unlawful Acts Unlawful Acts

It shall be unlawful for any It shall be unlawful for any person –person –

17

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(5) (5) To refuseTo refuse or negligently fail to or negligently fail to make, keep, or furnish any make, keep, or furnish any record, report, notification, record, report, notification, declaration, order or order form, declaration, order or order form, statement, invoice, or statement, invoice, or information required under this information required under this subchapter or subchapter II of subchapter or subchapter II of this chapter; this chapter;

(10) Negligently to fail to keep a (10) Negligently to fail to keep a record or make a report under record or make a report under Section 830 of this title Section 830 of this title

18

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c) Penaltiesc) Penalties

(B) In the case of a (B) In the case of a violation of paragraph (5) violation of paragraph (5) or (10) of subsection (a) of or (10) of subsection (a) of

this section, the civil this section, the civil penalty shall not exceed penalty shall not exceed

$10,000$10,000

YES - $10,000 per ViolationYES - $10,000 per Violation19

Page 20: How to Survive a DEA Inspection Series: “Maintaining Your Pharmacy’s DEA Compliance” Independent Pharmacy Alliance of America Inc. (IPA) June 24, 2015.

What does What does this mean this mean

to you?to you?20

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That a statement like,That a statement like,

“I don’t have the time “I don’t have the time to keep track of my to keep track of my

records”records”

should should nevernever be part be part of your vocabulary.of your vocabulary.

21

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DEADEARECORD-RECORD-KEEPINGKEEPING

COMPLIANCECOMPLIANCE

Free Advice Free Advice fromfrom

Jim & CarlosJim & Carlos22

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RECORD-KEEPING RECORD-KEEPING REQUIREMENTSREQUIREMENTS

Biennial InventoryBiennial Inventory

Executed or Voided DEA Forms 222 Executed or Voided DEA Forms 222

Invoices for C-III to C-V DrugsInvoices for C-III to C-V Drugs

CMEA Certification (Annually) CMEA Certification (Annually)

Power of Attorney Power of Attorney

Theft and Lost Reports Theft and Lost Reports

Drug Destruction Reports Drug Destruction Reports23

Page 24: How to Survive a DEA Inspection Series: “Maintaining Your Pharmacy’s DEA Compliance” Independent Pharmacy Alliance of America Inc. (IPA) June 24, 2015.

Title 21 CFR 1304.04 – Title 21 CFR 1304.04 – Maintenance of records and Maintenance of records and

inventoriesinventories

“(a) Every inventory and other “(a) Every inventory and other records required to be kept records required to be kept

under this part must be kept by under this part must be kept by the registrant and be available, the registrant and be available,

for at least 2 years from the for at least 2 years from the date of such inventory or date of such inventory or

records, for inspection and records, for inspection and copying by authorized copying by authorized

employees of the employees of the Administration.”Administration.”

Civil Action = 5 YearsCivil Action = 5 Years

24

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READILY RETRIEVABLEREADILY RETRIEVABLE

The term The term readily retrievablereadily retrievable means means that certain records are kept by automatic that certain records are kept by automatic

data processing systems or other electronic data processing systems or other electronic or mechanized record-keeping systems in or mechanized record-keeping systems in such a manner that they can be separated such a manner that they can be separated out from all other records in a reasonable out from all other records in a reasonable

time and/or records are kept on which time and/or records are kept on which certain items are asterisked, redlined, or in certain items are asterisked, redlined, or in

some other manner visually identifiable some other manner visually identifiable apart from other items appearing on the apart from other items appearing on the

records.records.

Title 21, Code of Federal Regulations Title 21, Code of Federal Regulations Section 1300.01(38)Section 1300.01(38)

25

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Biennial InventoryBiennial Inventory

- Required every two year - Required every two year after the Initial Inventoryafter the Initial Inventory

- Physical Inventory of all - Physical Inventory of all C-II through C-V C-II through C-V on handon hand

including Outdated including Outdated Controlled SubstancesControlled Substances

Title 21, Code of Federal Regulations Section Title 21, Code of Federal Regulations Section 1304.11 (a) & (b)1304.11 (a) & (b) 26

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ORDER FORMSORDER FORMS(DEA Form 222)(DEA Form 222)

“Must be Available for “Must be Available for Inspection”Inspection”

Electronic Electronic vs.vs. Paper DEA Paper DEA 222222

Proper notation includesProper notation includes::

-Date Drugs were Received-Date Drugs were Received-Quantity Received-Quantity Received

-Initials of Person Receiving the -Initials of Person Receiving the DrugsDrugs

27

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PURPOSE OF CSOSPURPOSE OF CSOS

- Eliminate the - Eliminate the costcost of of mailing order mailing order requisitions requisitions

- Reduce the - Reduce the timetime to get to get you the Schedule II you the Schedule II

ordersorders

- - NotNot to make your life to make your life easiereasier 28

Page 29: How to Survive a DEA Inspection Series: “Maintaining Your Pharmacy’s DEA Compliance” Independent Pharmacy Alliance of America Inc. (IPA) June 24, 2015.

Title 21 CFR 1305.22 – Title 21 CFR 1305.22 – Procedure for filling Procedure for filling electronic orders electronic orders

“(g) When a purchaser “(g) When a purchaser receives a shipment, the receives a shipment, the purchaser must purchaser must createcreate a a record of the quantity of record of the quantity of each item received and each item received and the date received. The the date received. The

record must be record must be electronically linked to the electronically linked to the

original order and original order and archived.”archived.”

29

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Title 21 CFR 1305.27 – Title 21 CFR 1305.27 – Preservation of electronic Preservation of electronic

ordersorders

“(a) A purchaser must, for each “(a) A purchaser must, for each order filled, retain the original order filled, retain the original

signed order and all linked signed order and all linked records for that order for two records for that order for two

years.”years.”

“(c) If electronic order records “(c) If electronic order records are maintained on a central are maintained on a central server, the records must be server, the records must be

readily retrievable at the readily retrievable at the registered location”registered location”

30

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Title 21 CFR 1305.28 – Title 21 CFR 1305.28 – Canceling and voiding Canceling and voiding

electronic orderselectronic orders

“(b) The purchaser must “(b) The purchaser must retain an electronic copy retain an electronic copy

of the voided order.”of the voided order.”31

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Title 21 CFR 1305.22 – Title 21 CFR 1305.22 – Procedure for filling Procedure for filling

electronic orderelectronic order

“(e) If an order cannot be “(e) If an order cannot be filled in its entirely, a filled in its entirely, a

supplier may fill it in part supplier may fill it in part and supply the balance by and supply the balance by

additional shipments within additional shipments within 60 days following the date 60 days following the date

of the order.”of the order.”32

Page 33: How to Survive a DEA Inspection Series: “Maintaining Your Pharmacy’s DEA Compliance” Independent Pharmacy Alliance of America Inc. (IPA) June 24, 2015.

““The following information is The following information is being given to you free of being given to you free of

charge and will save you lots charge and will save you lots of headaches, aggravation, of headaches, aggravation,

money, attorney fees, money, attorney fees, consultant fees and payment consultant fees and payment

to the U.S. government in to the U.S. government in the form of a fine. You are the form of a fine. You are not required to follow their not required to follow their

advice”advice”

Jim & CarlosJim & CarlosJune 24, 2015June 24, 2015

33

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YOU RECEIVED THE DRUGSYOU RECEIVED THE DRUGS

- Print out a copy of the order - Print out a copy of the order formform

- Verify the contents of the tote - Verify the contents of the tote with invoicewith invoice

- Confirm order on CSOS- Confirm order on CSOS

- Staple electronic order form to - Staple electronic order form to invoice invoice (Optional)(Optional)

- Indicate date received, amount - Indicate date received, amount received and who verified the received and who verified the

order on order formorder on order form

- Maintain them on a monthly - Maintain them on a monthly basisbasis

34

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C-III THROUGH C-V INVOICESC-III THROUGH C-V INVOICES

“Must be Available for Inspection”“Must be Available for Inspection”

Proper notation includesProper notation includes::

-Date Drugs were Received-Date Drugs were Received-Quantity Received-Quantity Received

-Initials of Person Receiving the -Initials of Person Receiving the DrugsDrugs

Title 21, CFR Section 1304.21 & .22Title 21, CFR Section 1304.21 & .2235

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POWER OF ATTORNEYPOWER OF ATTORNEY

“(a) A registrant may authorize “(a) A registrant may authorize one or more one or more individualsindividuals, whether or not located at his or her , whether or not located at his or her

registered location, to issue orders for registered location, to issue orders for Schedule I and II controlled substances on the Schedule I and II controlled substances on the

registrant's behalf by executing a power of registrant's behalf by executing a power of attorney for each such individual, if the attorney for each such individual, if the power power

of attorney is retained in the filesof attorney is retained in the files, with , with executed Forms 222 where applicable, for the executed Forms 222 where applicable, for the

same period as any order bearing the signature same period as any order bearing the signature of the attorney. The power of attorney of the attorney. The power of attorney must be must be

available for inspectionavailable for inspection together with other together with other order records.”order records.”

21CFR Section 1305.05 - Power of Attorney 21CFR Section 1305.05 - Power of Attorney 36

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THEFT & LOSS THEFT & LOSS REPORTREPORT

“Any Theft or Significant “Any Theft or Significant Loss Should be Reported”Loss Should be Reported”

“Always Maintain a Copy “Always Maintain a Copy of the DEA Form 106 with of the DEA Form 106 with

Your Inventory”Your Inventory”

Title 21, Code of Federal Regulations Section Title 21, Code of Federal Regulations Section 1301.76(b) 1301.76(b)

DEA Pharmacist Manual April 2010DEA Pharmacist Manual April 201037

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What is What is significant loss?significant loss?

Pharmacist ManualPharmacist Manual

2010 201038

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WHAT IS REQUIREDWHAT IS REQUIRED

- Notify your local DEA Office, in writing, - Notify your local DEA Office, in writing, within one business day of discovery - within one business day of discovery -

21CFR1301.76(b)21CFR1301.76(b)

- Submit a DEA Form 106 on DEA Diversion - Submit a DEA Form 106 on DEA Diversion WebsiteWebsite

DEA FORM 106 INFORMATIONDEA FORM 106 INFORMATION

Drug, Quantity, Strength, NDC Drug, Quantity, Strength, NDC NumberNumber

Explanation of Theft/LossExplanation of Theft/LossPolice Department You Reported the Police Department You Reported the

Theft/LossTheft/LossNumber of Previous Theft/LossNumber of Previous Theft/Loss

39

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DRUG DESTRUCTIONDRUG DESTRUCTION

Only those persons registered with Only those persons registered with and authorized by DEA to handle and authorized by DEA to handle

controlled substances may utilize & controlled substances may utilize & submit DEA Form 41 submit DEA Form 41

DEA Closed Loop SystemDEA Closed Loop System

- DEA is Now a Friend of the - DEA is Now a Friend of the EnvironmentEnvironment

- Use of Reverse Distributors are - Use of Reverse Distributors are EncouragedEncouraged

- Must be Maintained with Inventory - Must be Maintained with Inventory RecordsRecords

40

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CMEA RequirementsCMEA Requirements(Combat Methamphetamine Epidemic (Combat Methamphetamine Epidemic

Act)Act)

- - ValidValid Annual CertificationAnnual Certification

- Employee Required CMEA Training- Employee Required CMEA Training

- Limits Daily Sales to 3.6 Grams- Limits Daily Sales to 3.6 Grams

- Placement of Products- Placement of Products

- Sales (DEA 2 Years of Records)- Sales (DEA 2 Years of Records)

- Required Customer Information- Required Customer Information41

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SECURITYSECURITY

42

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SECURITY REQUIREMENTSSECURITY REQUIREMENTS

All applicants and registrant shall provide All applicants and registrant shall provide effective controls and procedureseffective controls and procedures to guard to guard against theft and diversion of controlled against theft and diversion of controlled

substances. In order to determine whether substances. In order to determine whether a registrant has provided effective control a registrant has provided effective control against diversion, the Administration shall against diversion, the Administration shall use the security requirements set forth in use the security requirements set forth in

Sections 1301.72 – 1301.76Sections 1301.72 – 1301.76 as standards for as standards for the physical security control and operating the physical security control and operating procedures necessary to prevent diversion.procedures necessary to prevent diversion.

Title 21, Code of Federal Regulations Title 21, Code of Federal Regulations Section 1301.71(a)Section 1301.71(a) 43

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Security RequirementsSecurity Requirements

Alarm SystemsAlarm Systems

CCTV Systems CCTV Systems

Employee Background Employee Background

44

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ALARM SYSTEMALARM SYSTEM

- Include a Back-Up Cell - Include a Back-Up Cell SystemSystem

- Should be Tested Often- Should be Tested Often

- Limit Employee Access- Limit Employee Access

45

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USE OF CCTV SYSTEMUSE OF CCTV SYSTEM

Sufficient Cameras to CoverSufficient Cameras to Cover

- Front of Store- Front of Store- Front Counter- Front Counter

- Pharmacy Counter- Pharmacy Counter- Rear of Pharmacy- Rear of Pharmacy- Dispensing Area- Dispensing Area

- C-II Cabinet or Storage - C-II Cabinet or Storage Room Room 46

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FELONY CONVICTION FOR CSFELONY CONVICTION FOR CS

“The registrant shall not employ, as an “The registrant shall not employ, as an agent or employee who has access to agent or employee who has access to

controlled substances, any person who controlled substances, any person who has been convicted of a felony offense has been convicted of a felony offense

relating to controlled substances or who, relating to controlled substances or who, at any time, had an application for at any time, had an application for

registration with the DEA denied, had a registration with the DEA denied, had a registration revoked or has surrendered a registration revoked or has surrendered a

DEA registration revoked or has DEA registration revoked or has surrendered a registration for cause …”surrendered a registration for cause …”

Title 21, Code of Federal Regulations Title 21, Code of Federal Regulations Section 1301.75(a)Section 1301.75(a) 47

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EMPLOYEE BACKGROUNDEMPLOYEE BACKGROUND

- Every Five Years- Every Five Years

- Verify the Last Two - Verify the Last Two EmployersEmployers

- Don’t Hire Anyone with a - Don’t Hire Anyone with a Controlled Substance Controlled Substance

Conviction (DEA Waiver)Conviction (DEA Waiver)

- Pre-Employment Agreement- Pre-Employment Agreement48

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PRESCRIPTIONSPRESCRIPTIONS

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Data Waived Data Waived PhysiciansPhysicians

- Treat Opiate - Treat Opiate DependencyDependency

- 30/100 Patient Limit- 30/100 Patient Limit- Only Subutex/Suboxone- Only Subutex/Suboxone

- Require DEA “X” - Require DEA “X” NumberNumber

Title 21, CFR Section 1301.28 Title 21, CFR Section 1301.28

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PHARMACIST IS NEVER PHARMACIST IS NEVER PERMITTED TO CHANGEPERMITTED TO CHANGE

- Patient’s Name- Patient’s Name

- Controlled Substance- Controlled Substance

- Prescriber’s Signature- Prescriber’s Signature

Source: DEA Information & Legal Source: DEA Information & Legal Resources General Q&AResources General Q&A

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PRESCRIPTION ISSUESPRESCRIPTION ISSUES

“All prescriptions for controlled “All prescriptions for controlled substances shall be dated as of, substances shall be dated as of,

and signed on, the day when and signed on, the day when issued issued and shall bearand shall bear the full the full

name and address of the name and address of the patient, the drug name, patient, the drug name,

strength, dosage form, quantity strength, dosage form, quantity prescribed, direction for use, prescribed, direction for use, and the name, address and and the name, address and registration number of the registration number of the

practitioner.”practitioner.”

Title 21, CFR 1306.05 (a) Title 21, CFR 1306.05 (a) Manner of issuance of prescriptionManner of issuance of prescription

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PRESCRIPTION PRESCRIPTION ISSUESISSUES

- Date Patient saw Physician- Date Patient saw Physician

- Verify with Physician or - Verify with Physician or Office ManagerOffice Manager

- Write Name of Office Person - Write Name of Office Person Verifying the PrescriptionVerifying the Prescription

- Receptionist May Be Part of - Receptionist May Be Part of DiversionDiversion

Title 21, Code of Federal Regulations Section Title 21, Code of Federal Regulations Section 13061306

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PHARMACY AUDIT BY PBMPHARMACY AUDIT BY PBM

- Make sure the required - Make sure the required information is on the front of information is on the front of

prescription prescription (contact physician for (contact physician for

concurrence)concurrence)

- You have the right to dispute - You have the right to dispute their findingstheir findings

- They have the right to deny your - They have the right to deny your claim for a prescription written claim for a prescription written

without a legitimate medical without a legitimate medical purposepurpose

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MAILING OUT OF STATE MAILING OUT OF STATE

- Need to be Registered with - Need to be Registered with State as an “Out-of-State State as an “Out-of-State

Pharmacy”Pharmacy”

- Request Confirmation - Request Confirmation Service or Signature (FedEx, Service or Signature (FedEx,

UPS, etc.)UPS, etc.)

- Pharmacy - Pharmacy MustMust Comply with Comply with State PMPState PMP 55

Page 56: How to Survive a DEA Inspection Series: “Maintaining Your Pharmacy’s DEA Compliance” Independent Pharmacy Alliance of America Inc. (IPA) June 24, 2015.

DEA AUDITDEA AUDIT

- - Biennial Inventory ReportBiennial Inventory Report- CMEA Certificate for - CMEA Certificate for

PharmacyPharmacy- Executed DEA Forms 222 & - Executed DEA Forms 222 &

InvoicesInvoices- Power of Attorney Notice- Power of Attorney Notice

- C-II to C-V Filled - C-II to C-V Filled PrescriptionsPrescriptions

- Theft and Loss Reports (DEA - Theft and Loss Reports (DEA Form 106)Form 106)

- Destruction Reports (DEA - Destruction Reports (DEA Form 41)Form 41)

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PRESCRIPTION FORPRESCRIPTION FORBREAKTHROUGHBREAKTHROUGH

MEDICATIONMEDICATION

My Personal OpinionMy Personal Opinion&&

How Law Enforcement How Law Enforcement Sees ItSees It

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Page 58: How to Survive a DEA Inspection Series: “Maintaining Your Pharmacy’s DEA Compliance” Independent Pharmacy Alliance of America Inc. (IPA) June 24, 2015.

QUESTIONS & QUESTIONS & ANSWERSANSWERS

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Page 59: How to Survive a DEA Inspection Series: “Maintaining Your Pharmacy’s DEA Compliance” Independent Pharmacy Alliance of America Inc. (IPA) June 24, 2015.

James R. Schiffer, Esq.James R. Schiffer, Esq.Member of Member of

Allegaert Berger & Vogel LLPAllegaert Berger & Vogel LLPNew York, NYNew York, NY

Main: Main: 212-571-0550212-571-0550EmailEmail: : [email protected] [email protected]

Carlos M. AquinoCarlos M. Aquino

Compliance ConsultantCompliance ConsultantPharmaDiversion, LLCPharmaDiversion, LLC

Media, PAMedia, PADirect: Direct: 610-487-4663610-487-4663

Email: Email: [email protected]@pharmadiversion.com59


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