Reverse Distribution: An Intersection of Regulations Charlotte A. Smith, Senior Regulatory Advisor, PharmEcology Services, WM National Services, Inc.

Transcription

1 Reverse Distribution: An Intersection of Regulations Charlotte A. Smith, Senior Regulatory Advisor, PharmEcology Services, WM National Services, Inc.

2 Legal Disclaimer This course is solely for educational purposes and provides only a general description of various regulatory requirements. For a complete description, please consult the relevant federal and state regulatory statutes. Nothing in this presentation constitutes legal advice and you should not legally rely on any information provided in this presentation. We make no warranty, express or implied, with respect to such information and disclaim all liability resulting from any use or reliance of this information. 2

3 FDA, DOT, DEA, EPA The secret to successful navigation in any field is knowing what to pay attention to and when. It also helps to know where you are starting from and where you want to end up.

4 What To Pay Attention To FDA: Food and Drug Administration Drug Quality and Security Act (DQSA) Title II Drug Supply Chain and Security Act (DSCSA) DOT: Department of Transportation PHMSA Pipeline and Hazardous Materials Safety Administration Define and enforce hazardous materials transport

5 What To Pay Attention To DEA: Drug Enforcement Administration Define and enforce Controlled Substances Act, including new Drug Disposal Rule as of October, 2014 CSOS: Controlled Substance Ordering System (Schedule II drugs) using PKI (Public Key Infrastructure) EPA: Environmental Protection Agency plus state authorized programs Define and enforce hazardous waste regulations Applicability to outdated drugs Proposed rulemaking regarding healthcare (June, 2015)

6 Where Are We Starting From When Considering Reverse Distribution? Saleable, indated products being returned from pharmacies FDA, DOT, DEA Unsaleable, outdated products being processed for potential credit and eventual destruction DOT, DEA, EPA Recalls/Withdrawals FDA, DOT, DEA Consumer drug take-back options DEA

7 FDA: Drug Quality and Security Act Title I: Compounding Quality Act Sec. 503B Outsourcing Facilities Title II: Drug Supply Chain Security Act Primary provisions apply to reverse distribution of saleable products Exempt products destined for destruction Concepts of suspect product, illegitimate product (counterfeit, contaminated, stolen, etc.)

8 Saleable Returned Product - Deadlines Prior to November 27, 2017: Manufacturer: may accept returned product, may distribute without transaction history Wholesaler: Transaction history shall begin with the wholesale distributor that accepted the returned product November 27, 2017: Manufacturer: verifies product identifier before further distributing Wholesaler: may accept returned product only if transaction information and transaction statement is provided. Subsequent transaction history shall begin with wholesaler. November 27, 2018: Repackager: shall verify the product identifier for each sealed homogeneous case or on each package.

9 Verification of Saleable Returned Product: November 27, 2017 Verification of product identifier including standardized numerical identifier, for each sealed homogeneous case or each package Manufacturer Wholesaler Dispenser: may return product to the trading partner from which the dispenser obtained the product without providing the information

10 Nonsaleable Returned Product Returns to manufacturer, repackager, wholesaler, or returns processor: By manufacturer, wholesaler, repackager, dispenser; No need to provide transaction history, transaction information, transaction statement

11 Saleable or Nonsaleable Product A repackager may return a saleable or nonsaleable product to the manufacturer, repackager, or to the wholesale distributor from whom such product was received without transaction information on behalf of the hospital or other health care entity that took ownership of such product pursuant to the terms and conditions of any agreement between such repackager and the entity that owns the product.

12 Third Party Logistics Providers Expired product segregated from other products and returned to the manufacturer or repackager or destroyed Quarantine/destroy a suspect product if directed to do so by respective manufacturer, wholesale distributor, dispenser, or an authorized government agency

13 Summary of FDA Requirements Primarily concerned with saleable returned product Requirements of the Drug Supply Chain Security Act increase over ten year period from enactment Nov 27, 2013 Identification and management of suspect and illegitimate drugs a major concern No specific guidance for recalls Reverse distribution of expired and other non-saleable products are not impacted Multiple Draft Guidance documents issued over the past year in compliance with the DSCSA (listed in reference section)

14 Proposed Rulemaking DOT Pipeline and Hazardous Materials Safety Administration (PHMSA) Hazardous Materials: Reverse Logistics Notice of proposed rulemaking (NPRM) published in the Federal Register Monday, August 11, 2014* Comment deadline of October 10, 2014 was extended to November 10, 2014 Would affect 49 CFR Parts 171 and 173 Advanced Notice of Proposed Rulemaking (ANPRM) was published July 5, 2012 Final Rule Expected Approximately August 2015 *79 Fed. Reg (August 11, 2014)

15 Hazardous Materials: Reverse Logistics PHMSA proposing to revise Hazardous Materials Regulations Applicable to return shipments of certain hazardous materials by motor vehicle Define reverse logistics Establish regulations specific to hazmat shipments in reverse logistics Establish clear applicability to training requirements Provide special packaging for reverse logistics shipments Establish segregation requirements Allow more flexibility for the transportation of lead acid batteries

16 Definition of Reverse Logistics the process of moving goods from their final destination for the purpose of capturing value, recall, replacement, proper disposal, or similar reason. Individual consumers would not be considered hazmat employees

17 Applicability and Hazardous Classes (a) Limit exceptions for reverse logistics to shipments made by highway Consumer products in the following hazardous classes 1.4S, 1.4G (fireworks, flares, signals, ammunition) 2.1 Flammable Gases 2.2 Nonflammable Gases 3 Flammable and Combustible Liquids 4.1 Flammable Solids 5.1 Oxidizing Substances 5.2 Organic Peroxides 6.1 Toxic Substances 6.2 Infectious Substances 8 Corrosives (Liquids & Solids) 9 Miscellaneous Hazardous Materials (ID8000, UN3077, UN3082, UN3334, UN3335)

18 Packaging Package size limitations Leak tight, sift proof Securely closed, secured against shifting Protected against damage Inner packaging secured against movement within outer package

19 Packaging & Hazardous Communication Use of original package or package of equivalent strength or integrity Inner packaging must be leakproof, siftproof Liquids - Outer packaging must contain enough absorbent material to contain a spill from inner packaging Outer packaging marked with a common name or proper shipping name to identify hazardous material

20 Training Requirements Minimal amount of hazardous materials training Employee s knowledge of the types of materials that are being returned to the distribution centers Employees preparing reverse logistics shipments not subject to the Subpart H of Part 172-Training requirements IF:

21 Training Requirements cont. Employer has: Identified the hazardous material subject to this section Verified compliance with appropriate conditions/limitations Provided training and supervision to persons preparing or offering shipments Maintains a record of those employees receiving the training required

22 Training Requirements cont. Employee has: Received appropriate training applicable to the material offered: recognize hazardous materials, identify the hazards, prepare shipment properly Operator of a motor vehicle that contains a reverse logistics material must be informed of the presence of the hazardous material and must be informed of the requirements of this section

23 Exceptions May be transported with other hazardous materials without affecting its eligibility for exceptions Hazardous materials that may react dangerously with one another may not be transported in the same outer packaging Different hazard classes of materials in reverse logistics may be transported in the same cargo transport if adequately separated Shipments are subject to the incident reporting requirements but not subject to any other requirements of subchapter

24 HDMA Recommendations to PHMSA Docket No. PHMSA Clarify proposed packaging requirements and shipping name to accommodate reusable plastic totes Remove requirements that products need to be secured against shifting where products are in appropriate packaging Expand packaging specs to allow for performance based standards, at least for pharmaceuticals/healthcare products

25 HDMA Recommendations to PHMSA Docket No. PHMSA Confirm that Consumer Commodity is an acceptable shipping name for pharmaceuticals and healthcare products Expand flexibility of reverse logistics regulations to include transport of pharmaceuticals by all modes of transportation Establish a separate section within Part 173 for facilities within the pharmaceutical supply chain

26 DOT Summary Currently, all DOT PHMSA hazardous materials shipping regulations apply to reverse distribution of pharmaceuticals and other healthcare products The industry is liable to manage to the current regulations for both forward and reverse hazardous material distribution Final reverse logistics for hazardous materials regulations should provide some relief Regulations ONLY apply to products that are classified as hazardous materials Hazardous waste is managed entirely differently and will be addressed under the EPA section

27 The New DEA Disposal Regulation Published September 9 th, 2014; took effect October 9 th, 2014 Requirements to govern the secure disposal of controlled substances by both DEA registrants and ultimate users Regulations implement the Secure and Responsible Drug Disposal Act of 2010 Expands options for take-back events Creates mail-back programs and collection receptacle locations

28 The New DEA Disposal Regulation Law enforcement can remain involved at all 3 levels Authorized manufacturers, distributors, reverse distributors, narcotic treatment programs, retail pharmacies and hospitals/clinics with on-site pharmacies can voluntarily participate Pharmacies (retail and hospital/clinic) are authorized to maintain collection receptacles at long term care facilities Reorganizes and consolidates regulations on disposal of all controlled substances and role of reverse distributors

29 Healthcare Sectors Impacted by DEA Disposal Rule Registrant Disposal Hospitals, clinics, physicians, veterinarians, dentists Retail Pharmacies including LTCF Provider Pharmacies Manufacturers, Wholesalers, Reverse Distributors Non-Registrant Disposal Ultimate User collection programs, including law enforcement Mail-back Receptacles (kiosks) Single day events Ultimate User long term care facilities (LTCFs) Receptacles provided and managed by retail pharmacies and hospitals/clinics

30 Definition of Terms Reverse distribute ( ): to acquire controlled substances from another registrant or law enforcement for the purpose of: 1. Return to the registered manufacturer or another registrant authorized by the manufacturer to accept returns on the manufacturer s behalf 2. Destruction Reverse distributor ( ): a person registered with the Administration as a reverse distributor

31 Definition of Terms Employee: as defined under the general common law of agency. ( ) Criteria to determine employee status for the purpose of disposal: Directly paid by the registrant Subject to direct oversight by the registrant Required to follow the registrant s procedures etc. for handling controlled substances Subject to receive a performance rating or evaluation on a regular/routine basis Subject to disciplinary action by the registrant Required to render services at the registrant s registered location

32 Definition of Terms Disposal and dispose: to refer generally to the wide range of activities that result in CS being unavailable for further use or one entity ridding themselves of such substances (e.g., returns). (FR53547 col 2) A controlled substance can be disposed of by destruction, return, recall, sale, or through the manufacturing process. The new rule eliminates the authority of the SACs to individually authorize disposal methods for nonpractitioners, and retains this option for practitioners ( )

33 Definition of Terms Destruction ( ): Must be rendered nonretrievable. Incineration is the ONLY method currently accepted by DEA. Sewering and landfill disposal (mixing with kitty litter, etc.) do not meet non-retrievable standard. (FR53547 col 3)

34 Definition of Terms Non-retrievable: the condition or state to which a controlled substance shall be rendered following a process that permanently alters that controlled substance s physical or chemical condition or state through irreversible means and thereby renders the controlled substance unavailable and unusable for all practical purposes. Cannot be transformed to a physical or chemical condition or state as a controlled substance or controlled substance analogue.

35 Definition of Terms Methods of Destruction (FR col1): Intention to allow public and private entities to develop a variety of destruction methods that are secure, convenient, and responsible. Must also meet all other applicable Federal, State, tribal and local laws and regulations. Once nonretrievable, no longer subject to DEA regulations. Supersedes all existing MOAs and MOUs. Retains ability for practitioners to request assistance from the local special Agent in Charge (SAC). ( (a)(5)).

36 Expanded Concept of Reverse Distribute Inventories of Registrants that reverse distribute: detailed inventory requirements whether or not registrant is a reverse distributor (e) (3) Records for registrants that reverse distribute (e) (1) For controlled substances acquired for the purpose of return or recall to the manufacturer or another registrant authorized by the manufacturer to accept returns on the manufacturer s behalf pursuant to part 1317 of this chapter (2) For controlled substances acquired from registrant inventory for destruction pursuant to (a)(2), (b) (2) and (b)(4) of this chapter

37 Registrant Disposal of Non-Practitioner Inventory Promptly destroy that controlled substance.using an on-site method of destruction Promptly deliver that controlled substance to a reverse distributor s registered location by common or contract carrier or by reverse distributor pick-up at the registrant s registered location For return or recall, promptly deliver that controlled substance by common or contract carrier or pick-up to the registered person from whom it was obtained, the registered manufacturer of the substance, or another registrant authorized by the manufacturer to accept returns or recalls Promptly transport that CS by its own means to the registered location of a RD, the location of destruction, or the registered location of any person authorized to receive that CS for the purpose of return or recall

38 Non-practitioner Destruction Non-practitioner transports CS by its own means to a registered location for any authorized purpose, transportation shall be directly to the authorized registered location and 2 employees of the transporting non-practitioner shall accompany the CS to the registered destination location. Constantly moving and unnecessary or unrelated stops and stops of an extended duration shall not occur

39 Reverse Distributor Registration Requirements and Authorized Activities Acquisition of CS Pick-up of CS from registrant s location Receive CS delivered by common or contract carrier or directly by non-practitioner registrant Only to RD s registered location and may not be re-routed to any other location Shall be personally received by an employee of the RD at the registered location Upon acquisition of CS, RD shall: Immediately securely store until timely destruction or prompt return to the manufacturer or other registrant authorized by manufacturer Promptly deliver CS to manufacturer, etc. Timely destroy

40 Destruction of Controlled Substances by Reverse Distributor Reverse Distributor shall destroy or cause the destruction of any controlled substance received for the purpose of destruction no later than 30 calendar days after receipt. Transport to a non-registered location, e.g. incinerator Directly to the destruction location Two employees of the transporting registrant shall: Accompany the controlled substances to the destruction location Load and unload or observe the loading and unloading of the CS Shall personally witness the destruction of the controlled substance until it is rendered non-retrievable

41 Impact on Ultimate User Options Collection Events Receptacles (kiosks) Mail-Back Law Enforcement Reverse Distributors Collectors Retail pharmacies Hospitals/clinics with on-site pharmacies Narcotic Treatment Programs Manufacturers Distributors Reverse distributors Reverse Distributors with Incinerators Incinerators 41

42 DEA Summary Primary impact on reverse distribution involves potential for receipt and disposition of consumer take-back medications Primary negative impact is tightening of restrictions on disposal times and transport requirements Relationship between registrants and reverse distribution of in-date and expired controlled substances remains the same Form 222 for controlled substances in Schedule II Inventory for Schedules III-V No change in ARCOS reporting requirements

43 EPA: Environmental Protection Agency Resource Conservation and Recovery Act, RCRA (40 CFR ) Defines hazardous waste in the US and applies to all businesses Approximately 5% of drugs and drug formulations in the marketplace become a RCRA hazardous waste when discarded The generator of this hazardous waste is highly regulated as are the treatment, storage and disposal facilities (TSDF) that perform final disposition such as incineration Liability: civil and criminal, fines up to $37,500/violation/day

44 State Hazardous Waste Programs Must be as stringent as the federal program May be more stringent, e.g. California, Washington, Minnesota, Connecticut All states have authorized RCRA programs except Iowa and Alaska

45 Increased Enforcement of Hazardous Waste Regulations CVS ordered to pay $13.75 million in fines to 45 cities and towns in California for improper dumping of hazardous materials and hypodermic needles, April, 2012 Walmart to pay $82 million in fines for improper dumping of hazardous waste in California and Missouri, May, 2013 Walgreens ordered to pay $16.57 million for disposal violations in California, December, 2012 Concord Hospital, Concord, NH fined $205,000 in December, 2012 by New Hampshire Department of Environmental Services Aurora Health Care, Milwaukee, WI settles hazardous waste case for $340,000, May, 2014 SUNY Downstate Medical Center, Brooklyn, NY fined $156,710 by EPA, August, 2014

46 RCRA: The Defining Waste Regulation Resource Conservation & Recovery Act Enacted in 1976, enforced by the EPA and authorized states Federal regulation of the disposal of solid wastes Encourages the minimization of waste generation Defines hazardous waste Cradle to Grave tracking of hazardous waste 46

47 RCRA Risk Management & Liability Civil and criminal liability Civil: State/USEPA enforcement Criminal: Federal - FBI, Dept. of Justice States - State Police, Office of State s Attorney Corporate fines: $37,500/violation/day (EPA) Personal liability: fines and/or imprisonment Managers up through CEO liable 47

48 Who Is Liable Under RCRA? All businesses in any sector of the economy Manufacturers Wholesalers Third Party Logistics Providers Reverse Distributors Hospitals Clinics, surgery centers, physician and veterinary practices Retail pharmacies, infusion compounding centers Retail groceries (including imbedded pharmacies) Long term care facilities, assisted living facilities and LTCF provider pharmacies 48

49 Hazardous Waste Under RCRA P-listed pharmaceuticals (acutely hazardous) Sole active ingredient; unused; empty containers LD50 (oral) 50mg/kg Examples: nicotine, warfarin U-listed pharmaceuticals (toxic) Sole active ingredient; unused Examples: cyclophosphamide, mitomycin, lindane, selenium sulfide Pharmaceuticals that exhibit a characteristic of hazardous waste (D codes) Ignitability D001 Toxicity D004 D043 Corrosivity D002 Reactivity D003 49

50 Examples of Pharmaceuticals and Nutritionals That Become Hazardous Waste P-listed: Nicotine e.g. NicoDerm Warfarin e.g. Coumadin U-listed: Cyclophosphamide e.g. Cytoxan Lindane Toxicity Characteristic Insulin e.g. Humalog (m-cresol) Multidose Flu Vaccine e.g. Fluzone (thimerosal, mercury) Multivitamin/mineral nutritionals e.g. Centrum Silver (chromium, selenium) Silver Sulfadiazine Cream e.g. SSD (silver) Ignitability Characteristic Pressurized Inhalers e.g. Proventil Alcoholic solutions over 24% 50

51 Hazardous Waste Manifest: EPA and DOT Will be completed by hazardous waste vendor Must be signed by employee who has received DOT hazardous materials training Top copy will be returned by vendor; match to generator copy and save for 3 years 51

52 Reverse Distribution Conundrum: When Does an Outdated Drug Become a Waste? RCRA did not envision the concept of outdated drugs having credit value The classical reverse distribution industry considers outdated drugs to be products since they have economic value EPA generally and many states have accepted this stance due to the benefits of the reverse distribution system Value to healthcare industry More compliant management of drugs that become a hazardous waste Some states and some hardline EPA personnel insist that outdated drugs become a waste at the point of generation since there is no possibility of recycling or re-use Industry hopeful that proposed rulemaking to be released in June will address this issue positively 52

53 EPA to Propose New Regulations approximately June Proposal to Address the Management of Hazardous Waste Pharmaceuticals The Agency is in the process of developing a new proposal to establish appropriate standards for the management and disposal of hazardous waste pharmaceuticals generated by healthcare facilities This new proposed rulemaking will only pertain to those pharmaceutical wastes that meet the current definition of a RCRA hazardous waste and that are generated by healthcare-related facilities. 53

54 Summary: Return of Saleable Indates DEA: Traditional transfer between registrants; schedule II drugs require a Form 222; no CSOS between pharmacies and wholesalers EPA: Not relevant as no waste is involved FDA: DSCSA applies CSOS between ARCOS-reporting trading partners, e.g. drug wholesaler and reverse distributor DOT: Current Hazardous Material regulations; possible relief when new reverse logistics regulations finalized and published

55 Summary: Return of Unsaleable Products Unsaleable, outdated products being processed for potential credit and eventual destruction DOT, DEA, EPA Recalls/Withdrawals FDA, DOT, DEA, EPA Consumer drug take-back options DEA, EPA (consumer exemption applies federally)

56 Questions? Charlotte A. Smith, R. Ph., M.S. Senior Regulatory Advisor PharmEcology Services WM Sustainability Services

57 APPENDIX

58 Additional FDA Regulations

59 Definitions Sec. 581 Sec 202 Pharmaceutical Distribution Supply Chain Disposition- the removal of such product from the pharmaceutical distribution supply chain, which may include disposal or return of the product for disposal Return providing product to the authorized immediate trading partner from which such product was purchased or received, or to a returns processor or reverse logistics provider for handling of such product Returns processor or reverse logistics provider a person who owns or operates an establishment that dispositions or otherwise processes saleable or nonsaleable product credit to the purchaser, manufacturer, or seller or disposed of for no further distribution

60 Illegitimate Product Manufacturer Quarantine, disposition, or assist trading partner to disposition Keep records not less than six years Wholesale Distributor Disposition, assist a trading partner to disposition Keep records not less than six years Dispenser Disposition, assist a trading partner to disposition Keep records not less than 6 years Repackager Disposition, assist a trading partner to disposition Keep records not less than 6 years

61 FDA Draft Guidance Documents Required by DSCSA Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification, June 2014 The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements: Questions and Answers, October 2014 DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information, November 2014 DSCSA Implementation: Product Tracing Requirements Compliance Policy, December 2014 DSCSA Implementation: Annual reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers, December 2014

62 DEA Disposal Rule Consumer Take-Back Options

63 Collection Events: Collection Events Law Enforcement Reverse Distributors Only law enforcement officer can handle controlled substances Other organizations may partner with Law enforcement to sponsor the event Law enforcement shall appoint a law enforcement officer employed by the agency to oversee the collection Law enforcement officers shall maintain control and custody of the collected substances from the ultimate user or authorized representative until secure transfer, storage, or destruction has occurred At least one receptacle for the collection of controlled substances is recommended but not required at each event ( ) Only Schedules II, III, IV, V plus other non-controlled drugs if desired Incinerators No other persons may handle the controlled substances at any time (other than ultimate user or authorized person and law enforcement) 63

64 Collection Receptacles Law Enforcement Receptacles Reverse Distributors Collectors Registrants authorized to collect controlled substances from ultimate users: Retail pharmacies, Hospitals/clinics must have on-site pharmacy, Narcotic treatment programs, Manufacturers, Distributors, Reverse distributors, Long term care facilities at which registered hospitals/clinics with on-site pharmacies or retail pharmacies are authorized to maintain collection receptacles Incinerators 64

65 Collection Receptacles Law Enforcement Receptacles Reverse Distributors Incinerators Collectors Collection Receptacle Requirements: (e) Be securely fastened to a permanent structure so that it cannot be removed Be a securely locked, substantially constructed container with a permanent outer container and a removable inner liner The outer container shall include a small opening to allow contents to be added The outer container shall prominently display that only Schedules II-V controlled are acceptable (no illicit drugs) Collector may choose to accept non-controlled substances also Small opening shall be locked or made inaccessible when an employee is not present (e.g. when pharmacy is closed) 65

66 Collection Receptacles Law Enforcement Receptacles Reverse Distributors Collectors Inner liner requirements Waterproof, tamper-evident, tear-resistant Removable and sealable immediately upon removal with no touching of contents Contents not viewable from outside Size of the inner liner clearly marked e.g. 5 gallon, 10 gallon, etc. Inner liner bears a permanent, unique ID number that can be tracked Access restricted to employees of the collector Sealed by two employees immediately upon removal Shall not be opened, x-rayed, analyzed or otherwise penetrated Incinerators 66

67 Collection Receptacles Law Enforcement Receptacles Reverse Distributors Incinerators Collectors Collection Receptacle Usage: Only schedule II, III, IV & V in lawful possession can be accepted Non-controlled drugs may be commingled Only ultimate users and other authorized non-registrants can use No counting, sorting, inventorying or handling once deposited Collection Placement: Retail pharmacy: immediate proximity of pharmacy inventory and at which an employee is present Hospital/clinic: Area regularly monitored by employee; NOT in emergency or urgent care area Narcotic treatment program: securely locked room with no other CS Long term care facility: secured and regularly monitored by employees 67

68 Collection Receptacles Law Enforcement Receptacles Reverse Distributors Incinerators Collectors Long Term Care Facility requirements: Within 3 days of discontinuation of use Permanent DC by prescriber, resident s transfer, death Pharmacy/Hospital/Clinic with pharmacy may install, manage, maintain receptacle Installation, removal, transfer, storage of inner liner by either: 2 pharmacy employees or 1 pharmacy employee and 1 supervisor-level LTCF employee Inner liners may be stored up to 3 business days in a securely locked cabinet or room with controlled access Inner liners may be shipped to a reverse distributor (RD) or picked up by a RD All records to be retained by registrant Pharmacy personnel CANNOT return the inner liner to the pharmacy 68

69 Collection Receptacles Law Enforcement Receptacles Reverse Distributors Incinerators Collectors Records for Collectors: Date each unused inner liner acquired, Unique ID number, size Date liner is installed, address of location, unique ID number, size, registration number of collector, names and signature of 2 employees witnessing installation Date liner is removed and sealed, address of location, ID number, size, registration number, names and signatures of 2 employees witnessing removal Date, etc. that liner is transferred to storage Date, etc. that each liner is transferred for destruction, address and registration number of reverse distributor to whom transferred, unique ID number, size of liner, names and signatures of 2 employees 69

70 Summary Table of Recordkeeping for Collectors Using Receptacles/Inner Liners Inner Liner Records Acquisition Installation Removal & Sealing Transfer to Storage Date X X X X X Unique ID # X X X X X Size X X X X X Transfer for Destruction Address of Registrant Registration # of Collector Names/ Signatures 2 employees Address of RD Registration # of RD X X X X X X X X X X 70

71 Collection Receptacles Law Enforcement Receptacles Reverse Distributors Collectors Reverse Distributors and Distributors authorized to acquire CS from collection Receptacles May pick up CS from a registrant or collection site or receive CS delivered by common or contract carrier, or delivered directly by non-practitioner registrant Personally received by RD employees at registered location Immediately store in accordance with security controls Timely destroy CS or cause destruction no later than 30 calendar days after receipt Record of destruction to include DEA Form Incinerators 71

72 Collection Receptacles Law Enforcement Receptacles Reverse Distributors Incinerators Collectors Recordkeeping Requirements: Reverse Distributors: Number of sealed inner liners acquired from other persons, date of acquisition. number and size, unique ID number, Name, Address and registration number of person from whom acquired Date, place and method of destruction; Number of sealed inner liners, name, address, registration number of person from whom acquired, number and size of all inner liners, ID number, name and signature of 2 employees witnessing destruction Completed DEA Form 41 Record of receipt maintained with record of destruction 72

73 Summary Table of Recordkeeping for Reverse Distributors Receiving Inner Liners Inner Liner Records Acquisition Date X X Witnessed Destruction Record of receipt maintained with Revised Form 41 Record of Destruction # of Liners X X Unique ID # X X Size X X Name of Registrant Address of Registrant Registration # of Collector Names/ Signatures 2 employees DEA Form 41 X X X X X X X X 73

74 Mail-back Programs Mail-Back Reverse Distributors with Incinerators May be conducted by law enforcement or any collector that has at their registered location a method of destruction Limits non-law enforcement to a few RDs with on-site incinerators Common or contract carriers may be used Any person may partner with law enforcement or an appropriate collector Packages must be made available (free or for sale) Packaging must be nondescript Water- and spill-proof, tamper evident, tear-resistant, sealable Packages must be pre-addressed with address of collector or law enforcement Cost of shipping shall be postage paid Package shall have unique identification number enabling tracking Shall include instructions for user No personal information required 74

75 Mail-back Programs Mail-Back Reverse Distributors with Incinerators Responsibilities of Collector: Accept CS only within specified packages Notify DEA of receipt of unsolicited package within 3 days Make a reasonable effort to notify the public prior to discontinuing mail-back program Obtain written agreement of another collector who meets the requirements of on-site destruction to receive remaining packages Only law enforcement and employees of collector shall handle packages No packages received shall be opened, x-rayed, analyzed, or otherwise penetrated 75

76 Mail-back Programs Mail-Back Reverse Distributors with Incinerators Recordkeeping Requirements Unused packages at collector s address: Date made available, number of packages, unique ID number Unused packages provided to a 3 rd party to make available: Name of 3 rd party, physical address,. date sent, number of unused packages with corresponding unique ID numbers Sealed mail-back packages received by collector: Date of receipt, ID # Sealed mail-back packages destroyed by collector: Number destroyed, date and method of destruction, unique ID number of each, names and signatures of 2 employees who witnessed destruction 76

77 Mail-back Programs Mail-Back Additional Disposal Requirements Upon receipt the collector shall promptly: Destroy the package using an on-site method or securely store the package consistent with security requirements for schedule II CS until on-site destruction can occur Reverse Distributors with Incinerators 77

78 DEA Disposal Rule Healthcare Concerns

79 Registrant Disposal Concerns Expressed to DEA Ability to render a drug non-retrievable in an institutional setting Ability to transfer drug wastage to a reverse distributor from an institutional setting Restrictive definition of employee May not have two nurses available to witness the destruction who are employees of the hospital May not have any pharmacists who are employees of the hospital due to outsourcing of departments Clinics may have no one who is an employee of the Registrant, who is the physician Requirement to double witness the destruction of the CS until it is rendered non-retrievable

80 DEA Clarification Letter: October 17, 2014 once a controlled substance has been dispensed to a patient by an institutional practitioner on the basis of an order for immediate administration to a patient at the registrant's registered location, the substance is no longer in the practitioner's inventory. For example, after a pre-filled syringe or a single-dose vial or syringe is administered to a patient, any remaining substance in the syringe or vial is not required to be destroyed in accordance with new Part Such wastage cannot be disposed in a receptacle for ultimate user collection Controlled substances from the pharmacy s inventory cannot be disposed in a receptacle for ultimate user collection. All destruction must be in accordance with Federal, State, tribal, and local laws and regulations

81 DEA Clarification Letter: October 17, 2014 Although Part 1317 does not apply to pharmaceutical wastage, the DEA strongly encourages all practitioners to continue to adhere to security controls and procedures that ensure pharmaceutical wastage is not diverted. For example, most institutional practitioners have implemented policies that require two persons to witness and record destruction of pharmaceutical wastage. _practitioner_pharm_waste_ pdf