[Pharmwaste] FW: DEA Safe Drug Disposal proposed rule - summary and analysis

Price, John L. "Jack" John.L.Price at dep.state.fl.us
Mon Jan 7 11:17:02 EST 2013

Here is a summary of key points from my initial review of the Federal Register notice of notification of proposed Safe Drug Disposal Act rulemaking (FR notice attached). Underlines identify what I considered to be the key points. Those may not coincide with your key points. At first I was disappointed that governmental entities were not permitted to run take back events but with the opportunity for pharmacy takeback and mailback allowed,  I no longer think that we need an option for government run programs.  I do not have any suggestions for things that should be dropped from the rule or additional things that can be added. I could accept finalization of the draft rule but would like to hear other's comments about that and anything else in this proposed rule, especially if I have misinterpreted any parts of the draft regulation.

1.      Pharmacies can but governmental entities cannot run events or host collection receptacles. Neither pharmacies nor governmental entities seem to be allowed to run collection programs or site collection receptacles, executive  summary, p. 7.

a.       -However, p. 32 seems to allow pharmacies to collect via containers: "In particular, DEA is proposing to authorize registered retail pharmacies to become collectors because such registrants are open to the public and have theft and loss prevention measures within the pharmacy processing area as well as outside the confines of the prescription processing and pick-up area, which easily lends itself to secure collection receptacle placement." P.32

-          Governmental entities are not allowed to be collectors: "collection may occur only at the registered locations of manufacturers, distributors, reverse distributors, and retail pharmacies that are authorized to collect at those locations and at long term care facilities (LTCFs) at which registered retail pharmacies are authorized to maintain a collection receptacle"  Apparently, the Safe Disposal Drug Act did not give DEA authority to register entities only for collection: "Finally, with the passage of the Disposal Act, Congress did not provide DEA the authority to register persons specifically for the purpose of collecting and disposing of controlled substances from ultimate users. DEA is therefore restricted to operating within its previously existing statutory authority with regard to registration." P. 36

2.      "All of the proposed collection methods are voluntary and no person is required to establish or operate a disposal program." executive summary, p. 7,

3.      Mail-back programs can be provided at no cost or for a fee - executive summary, p. 7

4.      Controlled substances can be comingled with non-controlled substances - executive summary, p. 7

5.      Destruction standard is performance based not prescribed - p. 79 , executive summary, p. 9-10, also p.61, 65

-          standard is "non-retrievable" and intended to be "secure, convenient, and responsible, consistent with preventing the diversion of such substances";

b.      -" 'non-retrievable' means to permanently alter any controlled substance's physical and/or chemical state through irreversible means in order to render that controlled substance unavailable and unusable for all practical purposes." P. 80

-          "The 'as soon as practicable but no later than fourteen calendar day' requirement is unique to reverse distributors - other registrants that destroy must do so promptly and do not have to follow a specific time limit - because the primary business activity of reverse distributors, unlike other registrants, is to acquire controlled substances for the purpose of destruction or return." P. 71

-          "a standard of destruction - non-retrievable - for persons that destroy or cause the destruction of controlled substances. Some examples of current technology that may achieve the non-retrievable standard are incineration and chemical digestion. Flushing and mixing controlled substances with coffee grounds or kitty litter are examples of existing methods of destruction that do not meet the non-retrievable standard." P. 79

6.      Pharmacies can operate collection receptacles at long term care facilities, p. 32-33 and also exec summary

7.      "authorized collectors may conduct the following activities: (1) receive mail-back packages from ultimate users and persons lawfully entitled to dispose of an ultimate user decedent's property if the collector has and utilizes an on-site method of destruction;(2) install, manage, and maintain collection receptacles at locations for which the registrant is authorized to collect; and (3) promptly dispose of sealed inner liners and their contents as provided for in § 1317.05(c)(2)" p. 35

a.       1317.05(c) Collected Controlled Substances. (2) Collection Receptacles. Upon removal from the permanent outer shell, the authorized collector shall promptly: (i) Destroy the inner liner and its contents; or (ii) Store the inner liner and its contents at the collector's registered location in a manner consistent with the security requirements for Schedule II controlled substances until prompt destruction can occur." P.115

8.      Collectors must modify their DEA registration: "To obtain authorization to be a collector, a manufacturer, distributor, reverse distributor, or retail pharmacy must apply for a modification to their registration..." p.34

9.      Collectors may use reverse distributors and distributors for disposal/destruction of collected medications: "... law enforcement agencies and authorized collectors may not have the resources to destroy controlled substances received from ultimate users. Such persons may use the services of a registered reverse distributor for this purpose. DEA proposes in section 1317.55(a) to authorize registered reverse distributors to acquire for purposes of destruction controlled substances that have been collected by: (1) law enforcement agencies; and (2) authorized collectors through collection receptacles. DEA also proposes in section 1317.55(b) to authorize registered distributors, in addition to registered reverse distributors, to acquire for purposes of destruction controlled substances collected by authorized collectors through collection receptacles" p.38

10.  Take back events p. 41-

a.       -must still have law enforcement p.41

b.      -have at least 1 receptacle "should have at least one receptacle for the collection of permitted substances . . . that is securely locked and substantially constructed with an outer shell and removable inner liner.  " p. 42-43

11.  Mail back programs p. 43 -

a.       -sites receiving the mail back must " have and utilize an on-site method of destruction at their registered location" p. 43 and "authorized collector must promptly destroy the package on-site or securely store the package until prompt on-site destruction or timely notification to DEA of receipt of an unauthorized package in accordance with 1317.70(e) can occur." P.48

b.      -mail back package requirements "the packages are proposed to be postage paid (e.g., business reply), preaddressed to the authorizedmail-back location, nondescript, tamper-evident and tear-resistant, among other things." P. 45

c.       -record keeping to minimize diversion: "a collector conducting a mail-back program must keep inventory of mailers created and record the unique identification number of each mail-back package received" p. 46

12.  Collection receptacles p.49 -

-        any law enforcement agency or "any DEA registered manufacturer, distributor, reverse distributor, or retail pharmacy authorized as a collector" . . . (and certain authorized LTCFs [long term care facilities]. . . )"  may provide a receptacle p. 49

-        "may not be placed at non-registered locations such as libraries or community centers." P. 49

-        receptacle specifications - "The collection receptacles used by authorized collectors must have a permanent outer container with a removable inner liner. The outer container must have an opening big enough to allow contents to be added to the inner liner, but small enough to prevent removal of the inner liner contents. The opening must be capable of being locked at times when an authorized employee is not present, unless the collection receptacle is located in a secured area of a long term care facility which is regularly monitored by LTCF personnel." P. 50

-        "the inner liner must bear a permanent, unique identification number that enables the liner to be tracked" p. 50

-        "securely fastened to a permanent structure such as a wall, floor, or immovable countertop so that they cannot be removed." P. 51

b.      -" the removal of the inner liner of the collection receptacle shall be performed by or under the supervision of at least two authorized employees of the authorized collector." P. 51

-          Prompt destruction - "DEA is proposing the flexible "prompt" destruction, transfer, and storage standard for collectors rather than a specific time frame to ensure that controlled substances do not accumulate while pending destruction, transfer, or storage, while still accounting for the individual circumstances of registrants that operate and maintain collection receptacles." P. 53

13.  Long term care facilities p. 53 -

a.       -" only a registered retail pharmacy that receives authorization to collect at a specific long term care facility may manage and maintain collection receptacles at that long term care facility and remove or supervise the removal of the inner liner of the collection receptacles at that long term care facility" p. 53

-        "located in a secured area monitored by personnel of that long term care facility" p. 54

b.      -" access to the inner liner is restricted to authorized employees of the registered retail pharmacy" p.54

-          no employee of the long term care facility will have access to or influence over the contents of the collection receptacle, except to deposit controlled substances into it." p. 54-55

-        "long term care facilities be permitted to dispose of controlled substances in Schedules II through V on behalf of an ultimate user who resides or has resided at such long term care facility. As with all other collection methods,  controlled and non-controlled substances may be comingled in the collection receptacle." P. 55

-        LTCF employees not allowed to take substances to take back or send in mail back due to diversion concerns, however "LTCF residents themselves may utilize any other disposal method available to ultimate users, including mail-back programs and take-back events"  p. 56-57

14.  Package and inner liner storage security

a.       -collectors  must store "sealed mail-back packages and inner liners as though they are Schedule II controlled substances" p. 58

-          inventorying or counting collected substances - DEA considered but decided not to allow due to increased opportunity for diversion as the collected substances are accessible by the persons doing the counting; not allowing counting removes one more person from handling and one more opportunity for diversion p. 59

-          unique tracking number on each package or inner liner p. 60

15.  2 person integrity requirement - at least 2 authorized employees of the collection entity must load/unload ( or witness it) and witness destruction to reduce chances of diversion p. 66-67

16.  Record of destruction - "a registrant that destroys controlled substances or causes the destruction of controlled substances is required to maintain a record of the destruction in a form to be issued by DEA" p. 67

John L. (Jack) Price
Environmental Manager
Waste Reduction MS 4555
Florida Department of Environmental Protection
2600 Blair Stone Road
Tallahassee, FL  32399-2400
Fax: 850.245.8811
john.l.price at dep.state.fl.us<mailto:john.l.price at dep.state.fl.us>
Please Note:  Florida has a very broad public records law.  Most written communications to or from state officials regarding state business are public records available to the public and media upon request.  Your e-mail is communications and may therefore be subject to public disclosure.

Please take a few minutes to share your comments on the service you received from the department by clicking on this link DEP Customer Survey<http://survey.dep.state.fl.us/?refemail=John.L.Price@dep.state.fl.us>.
From: Chris Angel [mailto:info at greatlakescleanwater.org]
Sent: Thursday, December 20, 2012 12:03 PM
To: Ed Gottlieb
Cc: Allen Gilliam; ekrisiunas at aol.com<mailto:ekrisiunas at aol.com>; hodgetf at auburn.edu<mailto:hodgetf at auburn.edu>; burke.lucy at calrecycle.ca.gov<mailto:burke.lucy at calrecycle.ca.gov>; Nicolas Vaczek; 'Barry Fernandez'; amy.roering at co.hennepin.mn.us<mailto:amy.roering at co.hennepin.mn.us>; jcanderson27 at comcast.net<mailto:jcanderson27 at comcast.net>; Adams, Bobby; Scarborough, Jill R.; Poston, Johanna; Price, John L. "Jack"; Tenace, Laurie; Henricks, Ron; Reynolds, Shannan; Boroff, Suzanne; Partin, Tony; Deborah DeBiasi; Matthew C. Mireles; pickrel.jan at epamail.epa.gov<mailto:pickrel.jan at epamail.epa.gov>; stitzhal at fullcircleenvironmental.com<mailto:stitzhal at fullcircleenvironmental.com>; "Stevan Gressitt" <Gressitt Stevan; randsney at gmail.com<mailto:randsney at gmail.com>; chris angel; Tom Sinclair; Russell Mankes; Jim Mullowney; Theresa O'Keefe; 'Scott Cassel'; Jeff Hollar; jharris at sharpsinc.com<mailto:jharris at sharpsinc.com>; Jennifer (MPCA) Volkman; Joel Kreisberg; Fred Miller; dlotzer at uwhealth.org<mailto:dlotzer at uwhealth.org>; pharmwaste at lists.dep.state.fl.us<mailto:pharmwaste at lists.dep.state.fl.us>
Subject: DEA rules

TO: List Serve Particpants

FR: Chris Angel, Great Lakes Clean Water Org. Yellow Jug Old Drugs program

The new document is available today-all 140 pages dated 12.20.12 -Link Below


Scroll down to DEA-Happy reading-Happy Holidays

> Hi All,
> The Pharmwaste Listserv is not posting at the moment. I grabbed your email from a recent posting so at least some of the list could get this timely news. Please pass it on to your contacts!
> Ed
> A congressional staffer let me know yesterday:
> "the DEA has drafted a comprehensive Notice of Proposed Rulemaking (NPRM) to implement the Secure and Responsible Drug Disposal Act of 2010. The White House Office of Management and Budget concluded its review on December 14, 2012, and publication is anticipated on Friday this week. The draft NPRM proposes a variety of disposal options for how ultimate users may return controlled substances for the purpose of disposal. I do not know for sure, but I assume that these will be published as proposed rules with an opportunity for comment."
> Assuming there is an opportunity to comment, I would like to suggest that we use this Listserv to share our thoughts on the proposed rules. Having others perspectives would help me craft better comments. It could turn out that the DEA did a great job and all I will need to say is, "well done". I will certainly say that about as many parts as I can, to balance the suggested changes I will likely submit.
> Ed Gottlieb
> Chair, Coalition for Safe Medication Disposal
> Industrial Pretreatment Coordinator
> Ithaca Area Wastewater Treatment Facility
> 525 3rd Street
> Ithaca, NY 14850
> (607) 273-8381
> fax: (607) 273-8433

Chris Angel,President
Volunteer Board Of Directors
Great Lakes Clean Water Organization
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