DEA REGULATIONS

1. DEA REGULATIONS FOR THE VETERINARIAN Frances Cullen, PC 197 14th Street, NW Suite 250 Atlanta, Georgia 30318 www.francullen.com (404) 806-6771

2. OVERVIEW 1. Regulation of Controlled Substances – State of Georgia – Drug Enforcement Agency (“DEA”) and Georgia Drugs & Narcotics (“GDNA”) 2. Purchasing Controlled Substances 3. Power of Attorney 4. Required Recordkeeping 5. Initial Inventory 6. Inventory Control

3. OVERVIEW (Cont’d) 7. Administration 8. Prescriptions 9. Labeling 10. Waste disposal 11. Documentation 12. Security 13. Audits 14. Addressing Loss or Theft 15. Transportation of Controlled Substances 16. Diversion drug dependence by all professionals

4. DEA REGULATIONS YOU NEED TO KNOW • 42 CFR section 1301.12(a) - Requirement for Separate DEA for Different Locations • 42 CFR 1301.76 Other Security Measures • 42 CFR 1304.03,1304.04, 1304.21, 1304.22, – General Recordkeeping • 42 CFR 1304.5 – DEA Order Forms for Schedule II drugs Requirements • 42 CFR 1304.11 – Inventory Requirements-must denote open or close-every 2 years

5. DEA REGULATIONS YOU NEED TO KNOW (Cont’d) • 42 CFR 1304.22(d) – Requirement for Separate Records • 42 CFR 1305 – Power of Attorney • 42 CFR 1305.13 – DEA Form 222 • 42 CFR 1307.21 – Drug Disposal

6. PURCHASING CONTROLLED SUBSTANCES • Each provider must have a Valid DEA number • For Schedule II controlled substances, you must use DEA Form 222 Order forms signed by the practitioner or another person authorized to order controlled substances through a valid Power of Attorney • Controlled Substances may be purchased only from: • Another Registrant, Distributor, or Pharmacy

7. PURCHASING CONTROLLED SUBSTANCES (Cont’d) • Purchases and transfers for controlled substances in Schedules III—V only require a transfer form. A copy of the transfer form must be maintained by both the supplier and the receiver.

8. POWER OF ATTORNEY • A Registrant can authorize one or more individuals to issue orders for Schedule II controlled substances on the registrant’s behalf by executing a Power of Attorney (“POA”) • The POA must be maintained in the files with executed DEA Form 222 • The POA must be available for inspection.

9. REQUIRED RECORD KEEPING • Documentation is required every time a controlled substance changes hands. You must have a paper trail. • The trail is from the manufacturer, to the distributor, to the pharmacy and/or the practitioner, and to the end user. • State and Federal controlled substance laws require maintenance of controlled substance records for period of 2 years from the date of each inventory. The GA Board of Veterinary Practice requires maintaining records for 3 years. The Statute of Limitations under FDA law is 5 years, so a 5 year retention policy may be advisable.

10. RECORD KEEPING • Records must be maintained at the registered practice location and must be readily retrievable and open to inspection and copying. • A registrant must maintain a file of receipt records for their receipt of all controlled substances. • Keep records for the receipt of Schedule III-IV drugs separate from Schedule II DEA Form 222 Official Order Forms. • Keep your logbooks for 5 years, the Federal FDA Statute of Limitations.

11. RECORD KEEPING (Cont’d) • Keep accessible all DEA Form 222’s for Schedule II controlled substances • Keep accessible your invoices for Schedule III-V controlled substances.

12. KEY DETAILS FOR RECORD KEEPING • Registrants MUST maintain the following information for all controlled substances received: 1. Date of receipt 2. Drug Description a. Name c. Dose b. Drug strength d. Quantity received 3. Name, address and DEA number of the supplier 4. Name, address and DEA number of the recipient 5. Name or initials of employees verifying receipt of the drugs

13. DETAILED RECORD KEEPING (Cont’d) • Receipt records may be kept in a handwritten or typed log, or may be maintained electronically. • The third copies of all DEA Form 222 Order Forms must be signed and dated to verify receipt of the Schedule II drugs.

14. INITIAL INVENTORY • On the date of receipt and stocking of any controlled substance, you must perform an initial inventory of the controlled substances on hand. • The following information must be documented: 1. Date 2. Documentation of whether the inventory was taken at Opening or Close of business, or if the practice location is open 24 hours a day, the time of the inventory 3. Drug name 4. Drug strength 5. Dosage form 6. Quantity of dosage units on hand

15. INITIAL INVENTORY (Cont’d) • The initial inventory of Schedule II drugs must be maintained on a separate form and document then the initial inventory of Schedule III—V drugs. • Do not perform an inventory that combines Schedule II drug counts with drugs in Schedule III—V, and do not include any non-controlled drugs on inventory documents.

16. ANNUAL INVENTORY • An initial inventory is taken on the first day you start stocking controlled substances. • An annual inventory must be taken on any date that is within one year of initial stocking and, from then on, on any date within one year of the previous annual inventory date. • The same information must be maintained in the annual inventory as is required for an initial inventory.

17. CHECKLIST! All of the six areas of information listed for your initial inventory must be documented. • Schedule II drugs should be documented on a separate form. • Do not combine non-controlled drugs on the annual controlled substance inventory. • For tax purposes, and to save time and work, you may coincide your annual inventory date with the date of your business inventory at the end of the year.

18. COUNT, COUNT, COUNT! • Include all controlled substance dosage units in your inventory regardless of whether they are in stock bottles, have been set aside for destruction, are samples, or are outdated. • You must have an exact count for Schedule II controlled substances • When Schedule II controlled substances are counted, they must be hand-counted every time. No estimates!

19. COUNTING (Cont’d) • Counting Schedules III—V controlled substances: -You may open a bottle and estimate the number of units if the stock bottle is labeled to contain less than 1,000 dosage units. -If the stock bottle is labeled to contain 1,000 units or more, then an individual hand count must be performed to provide an exact count. • If you stock all schedules, you must have two annual inventory documents; one for Schedule II and one for Schedules III—V. • You may choose to perform them on the same date.

20. LOG YOUR INVENTORY! • Many practitioners choose to maintain an ongoing log of all drugs administered or dispensed. This provides an ongoing count every day of what they have used and what they still have on hand. • Perpetual logs are useful and encouraged, and deter theft and diversion, but do not replace the requirement to have a specific annual inventory document. They are also not required by law. • Annual inventories must always be separate documents that stand-alone and are maintained separately.

21. PRESCRIPTIONS • Prescriptions are written orders provided only to patients. • Prescriptions may not be written to obtain stock for administering and dispensing in a clinic. • A practitioner must establish a legitimate need to prescribe controlled substances through an assessment utilizing pertinent diagnostic tools and the determination that there is a valid need for the drug(s) prescribed. • A patient chart must be maintained!

22. PRESCRIPTIONS (Cont’d) • All prescriptions for controlled substances must contain the following information: 1. The date in the upper right hand corner must be the date the prescription was written and signed. 2. Name and address of the patient/pet owner 3. The species of the animal. 4. Drug name, dosage form, drug strength, quantity, and directions for administration. 5. Original ink signature of the veterinarian. 6. Veterinarian’s DEA number. 7. Name and address of the veterinarian

23. GA BOARD OF PHARMACY LAW • Effective October 2011, the Georgia Board of Pharmacy now requires that all Schedule II prescription drugs be sequentially numbered and written on approved security paper. • Keep a separate file of copies of your Schedule II prescriptions.

24. ADMINISTRATION/DISPENSING • Maintain a Controlled Substance Dispensing or Administration Log that contains the following: 1. Date of administration at facility or dispensing to patient 2. Patient name/owner 3. Patient address/owner 4. Drug name 5. Drug strength 6. Dosage form 7. Quantity 8. Whether it was Administered (A) or Dispensed (D) 9. Name or initials of employee performing the administering/dispensing

25. ADMINISTRATION/DISPENSING(Cont’d) • This administration/dispensing log should be maintained and filed separately from patient charts. • This document should account for the use and disposition of all controlled substances utilized in the practice.

26. WHAT’S IN A LABEL? Labeling: All controlled substances must be dispensed in child proof containers with required labels and stickers. Required labeling: 1. Date of dispensing 2. Name and address of dispensing practitioner 3. Patient’s name 4. Drug name, drug strength, dosage form and quantity 5. Directions for administration

27. WHAT’S IN A LABEL? (Cont’d) Warning labels: All controlled substances dispensed must bear a warning sticker that informs the owner that it is illegal to transfer controlled substances to anyone other than the patient for whom it was dispensed. These stickers are available through drug companies or pharmacies. Packaging: Controlled substance samples in FDA approved pre-packaged containers are not required to be repackaged. Controlled substances cannot be dispensed in envelopes, plastic bags or other unapproved containers.

28. DOCUMENT PATIENT CHARTS • All use of controlled substances must be documented in the patient’s chart. • Each prescription, administration and dispensing chart note must contain: 1. Date 2. Activity 3. Drug Name 4. Strength 5. Dosage Form 6. Quantity

29. DOCUMENT PATIENT CHARTS (Cont’d) • If you do not stock controlled drugs and you only prescribe, then controlled substance prescriptions must only be documented in the patients’ charts. • If you administer and dispense controlled substances, you must document this information both in the administration/dispensing log and then again in the patient chart.

30. WASTE YOUR CONTROLLED • Controlled substances are wasted or destroyed for two reasons 1. The drugs are outdated, expired or unwanted; or 2. They have been contaminated by patient contact.  • Only controlled substances contaminated by patient contact may be destroyed onsite by a practitioner. • When a drug has been contaminated by patient contact it should be destroyed beyond reclamation by two people and the required documentation should be completed. • Outdated/expired controlled substances may not be destroyed on site by a practitioner without prior approval from the United States Drug Enforcement Administration. 

31. WASTE YOUR CONTROLLED(Cont’d) • When a drug has not been contaminated and is expired, outdated, recalled or unwanted, it must be sent to a reverse distributor. • The DEA Website maintains a current list of reverse distributors. • The reverse distributor will inventory the drugs you wish to have destroyed, and they will remove and destroy the drugs for you. • They will provide you with a receipt to show that you transferred the controlled drugs to them. • This document must be maintained for 2 years.

32. TRANSFER OF CONTROLLED SUBSTANCES • You must maintain transfer records for transfers to a reverse distributor or if you sell controlled substances to another practitioner. • There is a pre-printed Transfer of Controlled Substances Form on the DEA website. • All transfers of Schedule II drugs must be documented on a DEA Form 222.

33. TRANSFER OF CONTROLLED SUBSTANCES (Cont’d) Schedule III—V drugs may be transferred on a form containing all required documentation: 1. Name, address and DEA number of the supplier 2. Name, address and DEA number of the receiver 3. Date of the transfer Name, strength, dosage form and quantity of the drug(s) transferred If both parties have a copy of these documents, it can serve as a transfer document for the supplier, and also a receipt record for the receiver.

34. DOCUMENT YOUR WASTE! Any unused portion of a syringe must be documented as “wastage”. “Wastages” may be documented on an administration/ dispensing log or on a separate document in the same file for the documentation of waste. When drugs are wasted or destroyed, they must be destroyed beyond reclamation. Always have a witness to your “wasting.”

35. DOCUMENT YOUR WASTE (Cont’d) When controlled substances are wasted because of contamination by patient contact, the following documentation must occur: 1. Log must have registrant’s name and address 2. Date of wastage 3. Time of destruction/wastage 4. Patient’s name 5. Drug name, drug strength, and quantity destroyed 6. The reason for the wastage 7. Signature or initials of the person performing the destruction 8. Signature or initials of the second person witnessing the destruction.

36. SECURITY!!! • All registrants are required to have adequate controls in place to detect and prevent the diversion of controlled substances. • Some security measures are physical, such as alarms, safes, and locks. • Other security measures include the implementation of good practice and office policies, and maintaining required records.

37. SECURITY AND STORAGE STORAGE: • All controlled substances must be stored in a securely locked and substantially built safe or cabinet. • The security provided must be commensurate with the quantity and types of controlled substances stocked. • Controlled substances may not be left out unattended and/or where unauthorized persons would have access to them. • Prescription pads should be secured in a locked drawer or cabinet.

38. EMPLOYEE SECURITY BACKGROUND CHECKS: • Obtain a criminal history or a Georgia Crime Information Center (GCIC) Report on all employees or potential employees.  • Employees with a criminal history of a conviction or plea to a drug crime may not have access to controlled substances unless the DEA grants a rule waiver for that person.

39. BEST PRACTICES FOR SECURITY • Routinely review controlled substance laws and regulations so you are familiar with requirements. 2. Contact DEA authorities when you have questions or concerns. 3. Implement a written policy to ensure compliance with the DEA and to ensure that employees know how controlled substances are to be handled in your office. 4. Conduct periodic training with your staff. 5. Conduct periodic reviews and self inspections of your own practice. 6. Periodically audit and reconcile your drug counts against your record keeping to ensure that all drugs are accounted for, no drugs are missing, and there are no record keeping errors.

40. BEST PRACTICES FOR SECURITY 7. Review your invoices from drug companies to ensure you authorized the drug purchase. 8. When possible, have all controlled drug activities performed by two people, not one. 9. The person who orders and purchases the drugs should be a different person than the person who receives, checks them in, and adds them to inventory. Ideally, a third person should pay the bills. 10. Separate the duties of ordering, receiving and paying so there are checks and balances.

41. BEST PRACTICES FOR SECURITY (Cont’d) • The person who receives controlled substance shipments and checks them in should have a second person verify what was received and that the drugs are accurately being added to the perpetual inventory logs. • Although not required, perpetual inventory logs are encouraged to provide an ongoing record of what you have dispensed and what you have remaining in supply. • Do not allow patients and visitors access to drug supplies! This means if drugs are missing, it is an employee who is responsible.

42. POLICIES AND PROCEDURES • Policies and procedures that require oversight and witnesses protect both you, your practice, and your employees because if there is a discrepancy in the drug count, consistent compliance with policies will protect you and your practice from theft and potential liability, and protect employees from false accusations. • Restrict the number of people who have access to your drugs. 3. Have a policy in place requiring random drug testing for employees. Even if you do not want to conduct random drug testing on a regular basis, you should be able to demand a drug test during the course of an internal investigation should drugs be missing.

43. POLICIES AND PROCEDURES (Cont’d) 4. Periodically you should personally review your administration and dispensing logs to make sure that an employee has not removed drugs and made up the name of a fictitious patient you don’t remember treating. 5. Set up a calendar or reminder system so you know when it is time for an annual inventory for the renewal of licenses and registrations.

44. HOW TO HANDLE LOSS/THEFT • There may be small losses in compounding or in using a syringe. These are considered insignificant losses occurring in the course of normal practice. You should document these so that your records will always balance. • A significant loss occurs anytime you are missing a controlled substance, you do not know where it went, and cannot account for it. These significant losses, which may indicate theft and diversion of controlled substances, must be reported to the DEA immediately upon discovery. 

45. CALL THE DEA & GDNA 1. When a significant loss or theft is discovered, immediately call, fax, or email the DEA 1(800)-882-9539. You should also report the loss by using DEA Form 106. The DEA form may be submitted electronically from their website at www.deadiversion.usodj.gov within one business day. 2. You may also want to call the GA Drugs and Narcotics Agency at (404) 656-5100.

46. TRANSPORTATION OF CONTROLLED SUBSTANCES • Everyone who orders, dispenses, prescribes or administers a controlled substance must be registered with the DEA. • Mobile practitioners should be registered at their “base” of operations – storage must occur at the base. • Your drugs must be stored and accounted for in accordance with DEA regulations. • Non-profit status does not exclude any practitioner from DEA requirements.

47. TRANSPORTATION OF CONTROLLED SUBSTANCES • Drugs should be removed from the vehicle when not doing ambulatory calls – remember hot summer weather and cold winter weather can affect drugs. • You must have a locked tool box in your vehicle for such use.

48. EUTHANASIA • Animal protection laws, along with Federal and State law govern euthanasia - O.C.G.A. § 4-11-5.1 et seq. • DEA Rules and Regulations • Georgia Board of Pharmacy Law and Rules • Georgia Board of Veterinary Medicine Law & Rules • Georgia Department of Agriculture Law & Rules

49. DEA RULES & REGULATIONS • A veterinarian regularly working in an impound facility must have a DEA number attached to the facility. • Controlled substances can be stored at the impound facility. • Veterinarian can issue a Power of Attorney for someone at the facility to receive and log in controlled substances. • Facility must have secure double locked storage for controlled substances.

50. DEA RULES & REGULATIONS(Cont’d) • For euthanasia performed part time at an impound facility or on-site, the veterinarian must follow DEA recordkeeping and security rules for the transport of controlled substances. • In transporting controlled substances, take only the amount you anticipate using. • Have written procedures in place for the transportation of controlled substances.