Frequently Asked Questions for Pharmacists on Controlled Substance Take-Back Programs
MONDAY, SEPTEMBER 22, 2014
On September 9, 2014, the federal Drug Enforcement Administration issued its final rules governing disposal of controlled substances. This rule allows – but does not require – retail pharmacies (and certain other DEA registrants) to become authorized collectors of controlled substances for disposal. This new rule authorizes ultimate users (i.e., patients) to transfer unwanted and unused controlled substances in their lawful possession to an authorized collector for safe, secure and responsible disposal. The full Final Rule and comments may be found here: http://www.deadiversion.usdoj.gov/fed_regs/rules/2014/2014-20926.pdf
Pharmacies interested in participating in take-back programs under the rule are strongly advised to read the full rule and comments. Below is some summary guidance to the rule’s operation. North Carolina pharmacies exploring this opportunity should also consider discussing details and seeking guidance from the Greensboro office of the Drug Enforcement Administration, (336) 547-4219.
1. What collection methods of pharmaceutical controlled substances does the DEA authorize?
a. Collection receptacles §1317.75
b. Mail-back programs §1317.70
c. Take back events conducted by law enforcement only §1317.65
2. Who may modify their DEA registration in order to become an authorized collector? §1301.51
c. Reverse distributors
d. Narcotic treatment programs
e. Hospital or Clinic with an on-site pharmacy
f. Retail pharmacies
3. How does a DEA registrant modify their registration to become an authorized collector? §1301.51(b)
a. Submit an online request http://www.deadiversion.usdoj.gov/drug_disposal/
or send a written request to Registration Unit at DEA (mailing address found in §1321.01)
b. The request shall contain: registrant’s name, address, registration number as printed on the certificate of registration, signature of registrant and the type of collection (mail-back and / or collection receptacle) that the registrant plans to conduct.
c. No fee will be collected for the modification of the registration to become an authorized collector.
d. Modification to a registration to become an authorized collector is voluntary. The new rule does not require any registrant to become a collector.
4. Who can return controlled substances to an authorized collector? §1317.30(b)
a. Ultimate users
b. Individuals lawfully entitled to dispose of an ultimate user decedent’s property
5. How does collection receptacle-based program work? §1317.75
a. The DEA registrant must have modified its registration to become an authorized collector §1301.51
b. Schedule II-V controlled substances that are lawfully possessed by an ultimate user or other authorized non-registrant person may be collected in a collection receptacle. Non-controlled substances may be comingled with controlled substances in collection receptacles. §1317.75(b)
c. Collection receptacles shall be placed securely and maintained inside a collector’s registered location, inside law enforcement’s physical location or at an authorized long term care facility.§1317.75(d)
d. Physical equirements for the inner liner of the collection receptacle: §1317.60
i. Water-proof; spill-proof; tamper-evident, tear-resistant
ii. Removable and sealable
iii. Opaque so that contents of liner is not viewable when sealed
iv. Size of liner clearly marked on bag
v. Bear a unique and permanent identification number for tracking of the liner
e. Record keeping requirements for inner liners §1304.22(f)(2), §1317.75(g)
i. Date each unused liner was acquired, unique identification number of each bag and size of unused liner (eg. 5-gallon, 10-gallon etc)
ii. Date and location address of installation of liner
iii. Date and location address of removal and sealing of liner, name of two (2) employees of the collector who oversaw the removal and sealing of the liner, unique identification number, size of liner removed and registration number of the collector
iv. Date of transfer to storage or for destruction of liner, unique identification number, size of liner removed, name of two (2) employees of the collector who oversaw the transfer for storage or destruction and the registration number of the collector
f. The removed and sealed inner liner must not be opened, x-rayed, analyzed or penetrated. §1317.70(f)
g. Sealed inner liners shall only be kept at the registered location in a securely locked, substantially constructed cabinet or securely locked room with controlled access except as authorized by §1317.80(d). §1301.75 (c )
h. The authorized collector must have and utilize an on-site method of destruction at its registered location or ensure safe transfer and transport for destruction by another authorized collector (e.g., reverse distributor). §1317.95
i. Must keep complete and accurate records of destruction (DEA Form 41) with names and signatures of 2 employees who witnessed the destruction. These records must be kept for 2 years. §1304.21(e)
6. How does a mail-back program work? §1317.70
a. The DEA registrant must have modified its registration with the DEA to become an authorized collector. §1301.51
b. The authorized collector must provide mailing envelopes that satisfy the following requirements §1317.70(c):
i. Nondescript without markings to identify the contents
ii. Water-proof; spill-proof; tamper-evident, tear-resistant and sealable
iii. Preaddressed to collector’s registered address or law enforcement’s physical address
iv. Postage paid
v. Unique identification number for tracking
vi. Instructions to user how to mail back package, who can send the package and what can be sent
c. For registrants authorized to collect through a mail-back program, the record of inventory shall include the following information about each mail-back package:
i. The date of inventory
ii. Number of mail-back packages
iii. Unique identification number of each package
d. The authorized collector must only accept controlled substances from ultimate users contained in appropriate packages provided by the collector. §1317.70(e )(1)
i. NOTE: if collector receives controlled substances from an ultimate user in a package not provided by the collector then the collector must notify DEA Field Division of Administration within three (3) business days of receipt of package and store in a secure manner until given further instruction by DEA. §1317.70(e)(2)
e. Upon receipt of mail-back packages, the authorized collector must not x-ray, open, analyze or penetrate the package. §1317.70(f)
f. Sealed mail-back packages shall only kept at the registered location in a securely locked, substantially constructed cabinet or securely locked room with controlled access except as authorized by §1317.80(d). §1301.75(c )
g. The authorized collector must have and utilize an on-site method of destruction at its registered location or ensure safe transport and transfer for destruction by another authorized collector registrant (e.g., reverse distributor). §1317.95
h. Must keep complete and accurate records of destruction (DEA Form 41) with names and signatures of 2 employees who witnessed the destruction. These records must be kept for 2 years. §1304.21(e )
7. Methods of destruction § 1317.90
a. All controlled substances shall be destroyed in compliance with applicable Federal, State, tribal and local laws and regulations and shall be rendered non-retrievable in order to prevent diversion and to protect the public health and safety.
b. Two (2) employees of the registrant shall personally witness the destruction of the controlled substance until it is rendered non-retrievable.
c. Must keep complete and accurate records of destruction (DEA Form 41) with names and signatures of two (2) employees who witnessed the destruction. These records must be kept for 2 years.
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