Recordkeeping Requirements for the Electronic Transfer of Electronic Prescriptions for Schedules II-V Controlled Substances between Pharmacies for Initial Filling

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
0061 Supporting Statement 2026 Final.docx	Supporting Statement A	Uploaded 2026-10-05	Available
21 USC 827(b).pdf	Supplementary Document	Uploaded 2023-07-27	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
252032	Recordkeeping for EPCS in Schedules II-V between Pharmacies for Initial Filling		Modified

ICR Details

OMB Control No: 1117-0061	ICR Reference No: 202610-1117-003
Status: Received in OIRA	Previous ICR Reference No: 202307-1117-003
Agency/Subagency: DOJ/DEA	Agency Tracking No:
Title: Recordkeeping Requirements for the Electronic Transfer of Electronic Prescriptions for Schedules II-V Controlled Substances between Pharmacies for Initial Filling
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 10/05/2026

table that charts list comparision

	Requested	Previously Approved
Expiration Date	36 Months From Approved	10/31/2026
Responses	12,900,000	25,000,000
Time Burden (Hours)	645,000	1,250,000
Cost Burden (Dollars)	0	110,000,000

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Abstract: In accordance with the Controlled Substances Act (CSA), every DEA registrant must 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. 21 U.S.C. 827 and 958. The records maintained by registrants must be kept and be available for at least two years for inspection and copying by officers or employees of the United States as authorized by the Attorney General. 21 U.S.C. 827(b)(3). The records must be in accordance with and contain such relevant information as may be required by regulations promulgated by DEA. 21 U.S.C. 827(b)(1). This information request would require pharmacies to create and maintain records documenting the transfer between pharmacies of unfilled electronic prescriptions for controlled substances in schedules II-V.

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Authorizing Statute(s): US Code: 21 USC 827 and 958 Name of Law: Controlled Substances Act
  

Citations for New Statutory Requirements: US Code: 21 USC 827 Name of Law: Controlled Substances Act

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 46484	07/23/2026
30-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 62560	10/01/2026
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

table that charts list of burden

IC Title	Form No.	Form Name
Recordkeeping for EPCS in Schedules II-V between Pharmacies for Initial Filling

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ICR Summary of Burden

table that charts list of burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	12,900,000	25,000,000	0	-12,100,000	0	0
Annual Time Burden (Hours)	645,000	1,250,000	0	-605,000	0	0
Annual Cost Burden (Dollars)	0	110,000,000	0	-110,000,000	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: 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” from number 12 in the Supporting Statement. The new requested annual cost represents the figure from number 13 in the Supporting Statement. There have been no statutory or regulatory changes affecting this information collection.

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Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 10/05/2026

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