CSA LAW & CFR REGULATIONS

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

2. James R. Schiffer, Esq.Member of Allegaert Berger & Vogel LLPNew York, NYCarlos M. AquinoCompliance ConsultantPharmaDiversion, LLCMedia, PAIndividuals may not modify or use this presentation without the expressed written consent of PharmaDiversion, LLC.

3. PHARMADIVERSIONDISCLAIMERS- We Do Not Represent DEA- We Do Not Speak on Behalf of DEA- We Suggest You Read the Mentioned Federal Laws and Regulationswww.deadiversion.usdoj.gov

4. DISCLAIMERS“Neither Counsel Schiffer or Consultant Aquino have any affiliation or financial relationship with IPA or any sponsor of this program.”

5. My Experience24 Years with Philadelphia Police(Last 10 years assigned to DEA Task Force)12 Years with PFD DEA Diversion(8 as an Investigator & 4 as a Supervisor)4 Years with PharmaDiversion LLC as a DEA Compliance Consultant2 Years with Pharma Compliance Group LLCas a DEA Compliance ConsultantBack with PharmaDiversion LLC

6. LEARNING OBJECTIVES- Criminal & Civil Actions- Role of DEA Office of Diversion Control- Record-Keeping Requirements- Security Requirements- Prescriptions Issues - Records for DEA Audit- Use of CSOS

7. www.deadiversion.usdoj.gov(Answer for Restless Night)INFO & LEGAL RESOURCES- Title 21 Regulations & Codified CSA- Questions & Answers- Significant Document Guidance- Pharmacist’s Manual 2010

8. DRUG ENFORCEMENT ADMINISTRATION (DEA) OFFICE OF DIVERSION CONTROL Responsible to Prevent, Detect, and Investigate Diversion of Pharmaceutical Controlled Substances & Regulated Chemicals While Ensuring an Adequate Supply for Legitimate Medical and Scientific Purposes- Enforcing the Federal Laws & Regulations relating to Schedules I to V Controlled Substances and Regulated Chemicals (Tactical Diversion Squad)- On-Site Audits and Inspections of Controlled Substances and Regulated Chemicals (Diversion Compliance Group)

9. ACTIONS BY DEA- Criminal Investigation- Civil Action through USAO- Administrative Actions- Referral to State Regulatory Agency

10. DEAADMINISTRATIVE ACTIONS- Letter of Admonition- Memorandum of Understanding- Voluntary Surrender of Registration(Never Surrender – Consult Attorney)- Order To Show Cause- Immediate Suspension- Revocation of Registration

11. DEFINITION OF A 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,

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

13. CSA LAW&CFR REGULATIONS

14. Title 21, United States Codes (Controlled Substances Act 1970)is the LAWTitle 21, Code of Federal Regulations Part 1300 to Endis the REGULATIONS

15. Title 21, United States Codes Section 829 – PrescriptionsTitle 21, Code of Federal Regulations Section 1306 - Prescriptions

16. Its Time to Scare Your Checkbook !!

17. CIVIL ACTIONS Title 21, United States CodesSection 842. Prohibited Acts B a) Unlawful Acts It shall be unlawful for any person –

18. (5) To refuse or negligently fail to make, keep, or furnish any record, report, notification, declaration, order or order form, statement, invoice, or information required under this subchapter or subchapter II of this chapter; (10) Negligently to fail to keep a record or make a report under Section 830 of this title

19. c) Penalties(B) In the case of a violation of paragraph (5) or (10) of subsection (a) of this section, the civil penalty shall not exceed $10,000YES - $10,000 per Violation

20. What does this mean to you?

21. That a statement like,“I don’t have the time to keep track of my records”should never be part of your vocabulary.

22. DEARECORD-KEEPINGCOMPLIANCEFree Advice fromJim & Carlos

23. RECORD-KEEPING REQUIREMENTSBiennial Inventory Executed or Voided DEA Forms 222Invoices for C-III to C-V Drugs CMEA Certification (Annually) Power of Attorney Theft and Lost Reports Drug Destruction Reports

24. Title 21 CFR 1304.04 – Maintenance of records and inventories“(a) 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 employees of the Administration.”Civil Action = 5 Years

25. READILY RETRIEVABLEThe term readily retrievable means that certain records are kept by automatic data processing systems or other electronic or mechanized record-keeping systems in such a manner that they can be separated out from all other records in a reasonable time and/or records are kept on which certain items are asterisked, redlined, or in some other manner visually identifiable apart from other items appearing on the records.Title 21, Code of Federal Regulations Section 1300.01(38)

26. Biennial Inventory- Required every two year after the Initial Inventory- Physical Inventory of all C-II through C-V on hand including Outdated Controlled SubstancesTitle 21, Code of Federal Regulations Section 1304.11 (a) & (b)

27. ORDER FORMS(DEA Form 222)“Must be Available for Inspection”Electronic vs. Paper DEA 222Proper notation includes:-Date Drugs were Received-Quantity Received-Initials of Person Receiving the Drugs

28. PURPOSE OF CSOS- Eliminate the cost of mailing order requisitions - Reduce the time to get you the Schedule II orders- Not to make your life easier

29. Title 21 CFR 1305.22 – Procedure for filling electronic orders “(g) When a purchaser receives a shipment, the purchaser must create a record of the quantity of each item received and the date received. The record must be electronically linked to the original order and archived.”

30. Title 21 CFR 1305.27 – Preservation of electronic orders“(a) A purchaser must, for each order filled, retain the original signed order and all linked records for that order for two years.”“(c) If electronic order records are maintained on a central server, the records must be readily retrievable at the registered location”

31. Title 21 CFR 1305.28 – Canceling and voiding electronic orders“(b) The purchaser must retain an electronic copy of the voided order.”

32. Title 21 CFR 1305.22 – Procedure for filling electronic order“(e) If an order cannot be filled in its entirely, a supplier may fill it in part and supply the balance by additional shipments within 60 days following the date of the order.”

33. “The following information is being given to you free of charge and will save you lots of headaches, aggravation, money, attorney fees, consultant fees and payment to the U.S. government in the form of a fine. You are not required to follow their advice”Jim & CarlosJune 24, 2015

34. YOU RECEIVED THE DRUGS- Print out a copy of the order form- Verify the contents of the tote with invoice- Confirm order on CSOS- Staple electronic order form to invoice (Optional)- Indicate date received, amount received and who verified the order on order form- Maintain them on a monthly basis

35. C-III THROUGH C-V INVOICES“Must be Available for Inspection”Proper notation includes:-Date Drugs were Received-Quantity Received-Initials of Person Receiving the DrugsTitle 21, CFR Section 1304.21 & .22

36. POWER OF ATTORNEY“(a) A registrant may authorize one or more individuals, whether or not located at his or her registered location, to issue orders for Schedule I and II controlled substances on the registrant's behalf by executing a power of attorney for each such individual, if the power of attorney is retained in the files, with executed Forms 222 where applicable, for the same period as any order bearing the signature of the attorney. The power of attorney must be available for inspection together with other order records.” 21CFR Section 1305.05 - Power of Attorney

37. THEFT & LOSS REPORT“Any Theft or Significant Loss Should be Reported” “Always Maintain a Copy of the DEA Form 106 with Your Inventory” Title 21, Code of Federal Regulations Section 1301.76(b) DEA Pharmacist Manual April 2010

38. What is significant loss?Pharmacist Manual 2010

39. WHAT IS REQUIRED- Notify your local DEA Office, in writing, within one business day of discovery - 21CFR1301.76(b)- Submit a DEA Form 106 on DEA Diversion WebsiteDEA FORM 106 INFORMATIONDrug, Quantity, Strength, NDC NumberExplanation of Theft/LossPolice Department You Reported the Theft/LossNumber of Previous Theft/Loss

40. DRUG DESTRUCTIONOnly those persons registered with and authorized by DEA to handle controlled substances may utilize & submit DEA Form 41 DEA Closed Loop System- DEA is Now a Friend of the Environment- Use of Reverse Distributors are Encouraged- Must be Maintained with Inventory Records

41. CMEA Requirements(Combat Methamphetamine Epidemic Act)- ValidAnnual Certification- Employee Required CMEA Training- Limits Daily Sales to 3.6 Grams- Placement of Products- Sales (DEA 2 Years of Records)- Required Customer Information

42. SECURITY

43. SECURITY REQUIREMENTSAll applicants and registrant shall provide effective controls and procedures to guard against theft and diversion of controlled substances. In order to determine whether a registrant has provided effective control against diversion, the Administration shall use the security requirements set forth in Sections 1301.72 – 1301.76 as standards for the physical security control and operating procedures necessary to prevent diversion.Title 21, Code of Federal Regulations Section 1301.71(a)

44. Security RequirementsAlarm Systems CCTV Systems Employee Background

45. ALARM SYSTEM- Include a Back-Up Cell System- Should be Tested Often- Limit Employee Access

46. USE OF CCTV SYSTEMSufficient Cameras to Cover- Front of Store- Front Counter- Pharmacy Counter- Rear of Pharmacy- Dispensing Area- C-II Cabinet or Storage Room

47. FELONY CONVICTION FOR CS“The registrant shall not employ, as an agent or employee who has access to controlled substances, any person who has been convicted of a felony offense relating to controlled substances or who, at any time, had an application for registration with the DEA denied, had a registration revoked or has surrendered a DEA registration revoked or has surrendered a registration for cause …”Title 21, Code of Federal Regulations Section 1301.75(a)

48. EMPLOYEE BACKGROUND- Every Five Years- Verify the Last Two Employers- Don’t Hire Anyone with a Controlled Substance Conviction (DEA Waiver)- Pre-Employment Agreement

49. PRESCRIPTIONS

50. Data Waived Physicians- Treat Opiate Dependency- 30/100 Patient Limit- Only Subutex/Suboxone- Require DEA “X” NumberTitle 21, CFR Section 1301.28