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  • jwgilbreath

Destruction of controlled substance documentation—- DEA form 41

Hello all!


From time to time I've had questions regarding documentation of drugs that are destroyed by a registrant...ex. If you have a broken vial of a controlled substance that cannot be used and cannot be sent to a reverse distributor. The following discussion is sort of long but I felt it would be good to show you where in the DEA regulations destruction documentation is discussed.


Below is from the pharmacist's manual related to breakage/spillage (page 64 of the 2022 version):


"Breakage and Spillage

While neither the CSA nor DEA’s regulations specifically address the breakage and/or spillage of a

controlled substance, DEA offers the following guidance, which was also published in the 2003

Notice of Proposed Rulemaking and guidance document, Reports by Registrants of Theft or

Significant Loss of Controlled Substances. 68 FR 40576 (Jul. 8, 2003). The witnessed breakage

or spillage of a controlled substance does not constitute a loss of controlled substances because

the registrant can account for the controlled substances. These types of incidents do not require

notification to DEA. If there is breakage, spillage, or other damage to controlled substances, but

the controlled substances are still recoverable, there are options for disposing of them:

1. Promptly destroy that controlled substance in accordance with 21 CFR 1317.90 using an onsite method of destruction. 21 CFR 1317.05.

2. Send those controlled substances to an entity registered with DEA to handle

returns/disposals (known as a reverse distributor). 21 CFR 1317.05(a)(2).

3. Contact the local DEA Diversion Field Office to request assistance to dispose of the

controlled substances pursuant to 21 CFR 1317.05(a), 1304.21(e).

If the breakage or spillage is clearly observed, but the controlled substances are not recoverable,

the registrant should document the circumstances of the event in his or her records. It is DEA’s

position that in order to maintain complete and accurate records in accordance with 21 CFR

1304.21(a) that non-recoverable breakage or spillage must be recorded on a DEA Form 41 and, as

with any other form of disposal under 21 CFR Part 1317, should be signed by two individuals who

can testify that a breakage or spillage occurred.These records must be maintained in the

registrant’s files and contain such information as required by 21 CFR 1304.22(c)."


--As you can see in the language above, the DEA recommends that if the medication is not "recoverable" to clean the breakage up and then document the lost product on a DEA form 41.


What about medication that is "recoverable" (in this incidence recoverable does not mean usable...it means you have the broken item such as a crushed tablet in your hand)? In this incidence noted in the manual, you see it is discussed how to handle in three possible ways---destroy it yourself, send to a reverse distributor, or call the local DEA field office for assistance. Let's say you decide to destroy the item at the pharmacy. As an aside, remember if you are going to destroy a controlled substance the DEA requires the product to be made "non-retrievable." Also for destruction, note that in the manual it refers you to two regulations (21 CFR 1317.90 and 1317.95):


"21 CFR 1317.90 Methods of destruction.

(a) All controlled substances to be destroyed by a registrant [note the language in this reg does not refer you to 21 CFR 1317.95(d) for this section but see the language below as it discusses the registrant destroying the product], or caused to be destroyed by a registrant pursuant to § 1317.95(c), shall be destroyed in compliance with applicable Federal, State, tribal, and local laws and regulations and shall be rendered non-retrievable."


"21 CFR 1317.95 Destruction procedures.

The destruction of any controlled substance shall be in accordance with the following requirements: 

(c) Transport to a non-registered location. If the controlled substances are transported by a registrant to a destruction location that is not a registered location, the following procedures shall be followed: 

(1) Transportation shall be directly to the destruction location (the substances shall be constantly moving towards their final destruction location and unnecessary or unrelated stops and stops of an extended duration shall not occur); 

(2) Two employees of the transporting registrant shall accompany the controlled substances to the destruction location; 

(3) Two employees of the transporting registrant shall load and unload or observe the loading and unloading of the controlled substances; 

(4) Two employees of the transporting registrant shall handle or observe the handling of any controlled substance until the substance is rendered non-retrievable; and 

(5) Two employees of the transporting registrant shall personally witness the destruction of the controlled substance until it is rendered non-retrievable. 

(d) On-site destruction. If the controlled substances are destroyed at a registrant's registered location utilizing an on-site method of destruction, the following procedures shall be followed: 

(1) Two employees of the registrant shall handle or observe the handling of any controlled substance until the substance is rendered non-retrievable; and 

(2) Two employees of the registrant shall personally witness the destruction of the controlled substance until it is rendered non-retrievable."


So as noted in the Pharmacist's Manual, if you destroy a controlled substance certain records are required as noted in 21 CFR 1304.21 [we will focus on (a) and (e)].


21 CFR1304.21 General requirements for continuing records.

(a) Every registrant required to keep records pursuant to § 1304.03 shall maintain, on a current basis, a complete and accurate record of each substance manufactured, imported, received, sold, delivered, exported, or otherwise disposed of by him/her, and each inner liner, sealed inner liner, and unused and returned mail-back package, except that no registrant shall be required to maintain a perpetual inventory.


(e) Record of destruction. In addition to any other recordkeeping requirements, any registered person that destroys a controlled substance pursuant to § 1317.95(d), or causes the destruction of a controlled substance pursuant to § 1317.95(c), shall maintain a record of destruction on a DEA Form 41. The records shall be complete and accurate, and include the name and signature of the two employees who witnessed the destruction. Except, destruction of a controlled substance dispensed by a practitioner for immediate administration at the practitioner's registered location, when the substance is not fully exhausted (e.g., some of the substance remains in a vial, tube, or syringe after administration but cannot or may not be further utilized), shall be properly recorded in accordance with § 1304.22(c), and such record need not be maintained on a DEA Form 41.


So, we've discussed the item either recoverable or not recoverable and the registrant destroying on sight making the item "non-retrievable" and using DEA Form 41. We also discussed the caveat noted in the Pharmacist's Manual if the item is totally unrecoverable and cannot be destroyed. In this case as noted you still use a using a DEA form 41 to document the destruction. In any of these cases the products were generally in the pharmacy or or maybe say for example if a product is dropped on a unit at the time of a fill or load say in an ADC. These items being destroyed are not being directly used by the facility for a patient. So, say on a unit if a nurse splits a tablet for administration to a patient after he/she/they pull the item from an ADC. How is this supposed to be documented?


Well the 21 CFR 1304.21(e) above discussed this situation. As noted in this specific regulation, a form 41 is not required BUT documentation IS required. The documentation must be in accordance with 21 CFR 1304.22 which states:

"21 CFR 1304.22 Records for manufacturers, distributors, dispensers, researchers, importers, exporters, registrants that reverse distribute, and collectors

(c)Records for dispensers and researchers. Each person registered or authorized to dispense or conduct research with controlled substances shall maintain records with the same information required of manufacturers pursuant to paragraph (a)(2)(i)(ii)(iv)(vii), and (ix) of this section. In addition, records shall be maintained of the number of units or volume of such finished form dispensed, including the name and address of the person to whom it was dispensed, the date of dispensing, the number of units or volume dispensed, and the written or typewritten name or initials of the individual who dispensed or administered the substance on behalf of the dispenser. In addition to the requirements of this paragraph, practitioners dispensing gamma-hydroxybutyric acid under a prescription must also comply with § 1304.26."


So, when you consider an ADC cabinet, basically all the information noted as required by 21 CFR 1304.22(c) can be found in the records of the ADC. So, documenting the waste of that product can be documented in the ADC and should meet the requirements set forth by the DEA.


I know this has been a very long post ...but...I felt it best to give the background and why you would need to use a DEA form 41. If your reverse distributor will handle crushed tablets consider letting them take ownership of the product and letting them complete the required documentation: if you have to destroy broken products be mindful of needing a witness and complete the destruction making the controlled substance non-retrievable. Document this on a DEA form 41. File the form once completed. A copy does NOT need to go to the DEA. IF the DEA does visit you though they may ask to see the form 41s. Also, remember to remove the products from your perpetual inventories! If you are performing a simulated DEA audit of a certain drug, make sure that you are pulling your form 41s to ensure those are accounted for during the audit process. Also, if the DEA is performing and audit on a certain drug ensure that you show a copy of the form 41 to the agent IF the drug of audit in question had previous required destructions.


Thanks Everybody!


Watch this space for other future post!



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