Supporting Statement for Paperwork Reduction Act Submissions

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Supporting Statement for Paperwork Reduction Act Submissions
Recordkeeping Requirements for the Transfer of Electronic Prescriptions for Controlled Substances (EPCS) in Schedules II-V between Pharmacies for Initial Filling
OMB Approval #1117-0061

The Drug Enforcement Administration (DEA) seeks approval by the Office of Management and Budget (OMB) for a new collection of information, Recordkeeping Requirements for the Transfer of Electronic Prescriptions for Controlled Substances (EPCS) in Schedules II-V between Pharmacies for Initial Filling.


Part A. Justification 

1.  DEA implements and enforces the Comprehensive Drug Abuse Prevention and Control Act of 1970, often referred to as the Controlled Substances Act (CSA), and the Controlled Substance Import and Export Act (CSIEA), as amended.1  The CSA requires every DEA registrant to make a biennial inventory and maintain, on a current basis, a complete and accurate record of each controlled substance manufactured, received, sold, delivered, or otherwise disposed of.2  These records must be maintained separately from all other records of the registrant, or alternatively, in the case of nonnarcotic controlled substances, be in such form that required information is readily retrievable from ordinary business records of the registrant.3  The records maintained by registrants must be retained and available for at least two years for inspection and copying by officers or employees of the United States as authorized by the Attorney General.4  The records must be in accordance with and contain such relevant information as may be required by regulations promulgated by DEA.5
 
2.  This information collection requires the transferring pharmacy to update the electronic prescription record to note that the prescription was transferred, and to add the following information:  the name, address, and DEA registration number of the pharmacy to which the prescription was transferred; the name of the pharmacist receiving the transfer; the name of the transferring pharmacist; and the date of the transfer.  The pharmacy receiving the transfer is required to update the electronic prescription record with the name, address, and DEA registration number of the pharmacy transferring the prescription, the name of the transferring pharmacist, the name of the pharmacist receiving the transfer, and the date of the transfer.

These recordkeeping requirements enable DEA to maintain complete accountability for all EPCS dispensed by a pharmacy.  This accountability allows DEA to maintain a closed system of distribution for EPCS and reduces opportunities for diversion.

3.  These requirements do not involve reporting, and therefore, issues related to electronic submission are not applicable.  The records of EPCS transfers between pharmacies will be maintained electronically in the pharmacies’ electronic prescription applications.

4.  DEA has made efforts to identify and prevent duplication of information.  The collection of this information is unique to DEA and is not duplicative.

5.  DEA expects this collection will not have a significant economic impact on a substantial number of small entities within the meaning and intent of the Regulatory Flexibility Act, 5 U.S.C. 601-612.

6.  Pursuant to 21 U.S.C. 827(b), records must be maintained for a period of at least two years.  DEA does not have the authority to reduce the burden or period of recordkeeping.  Failure to collect the information or to conduct the collection less frequently will contravene the CSA, reduce accountability, and increase the risks of diversion.

7.  There are no special circumstances applicable to this information collection. 

8.  The 60-day Notice was published in the Federal Register on July 23, 2026 at 91 FR 46484.  The comment period ended on September 21, 2026.  No comments were received.  The final rul published in the Federal Register on October 1, 2026, at 91 FR 62560.

DEA meets regularly with the affected industry to discuss policies, programs, and regulations.  These meetings provide an open forum to discuss matters of mutual concern with representatives of those entities from whom the information is obtained.

9.  This collection of information does not propose to provide any payment or gift to respondents.

10.  Information requested in this collection may be considered confidential business information if marked as such in accordance with 28 CFR 16.8(c) and Exemption 4 of the Freedom of Information Act (FOIA).  Submitters who are required to furnish commercial or financial information to the government are protected from the competitive disadvantages that could result from disclosure of such information.  The information is protected by DEA through secure storage, limited access, and federal regulatory and DEA procedures.  In the event a FOIA request is made to obtain information that has been designated as confidential business information per 28 CFR 16.8(c) and Exemption 4 of FOIA, the DEA will give written notice to the submitter to allow an opportunity to object within a reasonable time prior to any disclosure by DEA.

11.  This collection of information does not ask any questions of a sensitive nature.

12.  This rule will affect approximately 66,088 pharmacies who are registering with DEA to handle control substances. 

 Activity 
Number of Respondents
Frequency
Total Annual Responses
Time Per Response (Hours)
Total Annual Burden (Hours)
Hourly Rate*
 Monetized Value of Respondent Time 
Transfer of ESCP
                            66,088 
195.19429
12,900,000
0.05
      645,000 
 $97.38 
 $62,810,100 
Unduplicated Totals
                  66,088 
0
  12,900,000 
0.05
     645,000 
 $ 97.38 
 $ 62,810,100 
 



Hourly Rate*



Estimated hourly wage ($/hour):6
 $    68.05 

Load for benefits (percent of labor rate):7
43.1%

Loaded labor rate ($/hour):
 $    97.38 


13.  The estimated annual cost burden is zero.  Respondents are not estimated to incur any    a) additional start-up cost or capital expenditure, or b) additional operation and maintenance costs or purchase services as a result of this information collection.

14.  The required information is recorded and maintained by respondents.  There is no cost to the Federal Government.

15. The change in annual responses and annual burden hours reflects a decrease in electronic prescriptions for controlled substances.  Changes to the annual cost reflect change in methods. Previously, the approved 2023 figure represented the “Monetized Value of Respondent Time” calculated in section 12.  The new requested annual cost represents the figure from section 13.  There have been no statutory or regulatory changes affecting this information collection.  The table below summarizes the changes since the last renewal of this information collection. 


 
2023 Approved Burden
2026 New Requested Burden
Difference
Annual responses
     25,000,000 
 12,900,000 
    -12,100,000
Annual burden hours
      1,250,000 
      645,000 
         -605,000
Annual cost ($)
     11,000,000 
              -   
    -11,000,000


16.  DEA will not publish the results of the information collected.

17.  DEA is not seeking approval not to display the expiration date for OMB approval of this information collection.
 
18.  DEA is not seeking an exception to the certification statement “Certification for Paperwork Reduction Act Submissions” for this collection of information.  

Part B. Statistical Methods

DEA will not be employing statistical methods in this information collection.