Recordkeeping Requirements for Partial Fills of Prescriptions for Schedule II Controlled Substances

Forms and Documents

Document	Type	Status	Availability
1117-0057 CARA II Supporting Statement Final Rule 2023.docx	Supporting Statement A	Uploaded 2023-07-21	Repair queued
21 USC 829(f).pdf	Supplementary Document	Uploaded 2023-07-21	Repair queued

IC Document Collections

IC ID	Collection	Type	Status	Form
246121	Recordkeeping Requirements for Partial Fills of Prescriptions for Schedule II Controlled Substances		Modified

ICR Details

OMB Control No: 1117-0057	ICR Reference No: 202307-1117-001
Status: Received in OIRA	Previous ICR Reference No: 202103-1117-001
Agency/Subagency: DOJ/DEA	Agency Tracking No:
Title: Recordkeeping Requirements for Partial Fills of Prescriptions for Schedule II Controlled Substances
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 08/08/2023

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	18,187,640	0
Time Burden (Hours)	50,521	0
Cost Burden (Dollars)	0	0

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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. These records must be maintained separately from all other records of the registrant or, alternatively, in the case of non-narcotic controlled substances, be in such a form that required information is readily retrievable from the ordinary business records of the registrant. 21 U.S.C. 827(b)(2). 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). On July 22, 2016, the President signed the Comprehensive Addiction and Recovery Act (CARA) of 2016 into law as Public Law 114-198, which included amending the CSA to allow for the partial filling of prescriptions for schedule II controlled substances under certain conditions. 21 U.S.C. 829(f). Upon filling a prescription for a partial fill of a schedule II controlled substance, a pharmacy will have to create and maintain certain records relating to the partial fill.

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Authorizing Statute(s): US Code: 21 USC 827 Name of Law: Comprehensive Addiction and Recovery Act of 2016
   US Code: 21 USC 957
   US Code: 21 USC 829
  

Citations for New Statutory Requirements: US Code: 21 USC 829(f)

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
1117-AB45	Final or interim final rulemaking	88 FR 46983	07/21/2023

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Recordkeeping Requirements for Partial Fills of Prescriptions for Schedule II Controlled Substances

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ICR Summary 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	18,187,640	0	0	18,187,640	0	0
Annual Time Burden (Hours)	50,521	0	0	50,521	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to: Changing Regulations

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

Burden Reduction Due to:

Short Statement: This is a new 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: 08/08/2023

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