SOPREFERENCE OUTLINE

Controlled Substance Recordkeeping Procedure

Recordkeeping procedure for a regime aimed at diversion rather than product quality, which sits outside the GMP harmonisation architecture entirely. Covers registration scope, the initial and biennial inventories, separation of Schedule I and II records, readily-retrievable tested rather than asserted, unit-level accountability treating a discrepancy as a diversion signal, and physical security. Maps to 21 CFR Part 1304.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

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REGULATIONS MAPPED
21 CFR Part 1304
DOCUMENT TYPE
SOP
LAST UPDATED
August 2026
PURPOSE

Controlled substance recordkeeping sits outside the GMP harmonisation architecture entirely: there is no ICH position and no mutual recognition, the registering authority’s concern is diversion rather than product quality, and the requirements are prescriptive where quality regulations are principle-based. A facility with an excellent quality system can be comprehensively non-compliant here. Whether a count discrepancy is an arithmetic error or a diversion signal is your determination.

What's Inside

✓Registration scope stated in terms of what it permits and, just as importantly, what it does not
✓Initial and biennial inventory records, with the next due date diarised rather than remembered
✓Separation of Schedule I and II records from all others, held as a prescriptive requirement
✓Readily-retrievable retention, with a retrieval test actually performed and the elapsed time recorded
✓Unit-level accountability from receipt through to administration, dispensing, destruction or return, with nothing left unaccounted
✓Discrepancy handling that opens as a possible diversion enquiry before any reconciliation is attempted
✓Physical security controls recorded alongside the records they protect, so both are inspected together

How to Use It

1Map your registration scope first; activities the registration does not permit are non-compliant however well your quality system documents them.
2Do not assume quality-system recordkeeping satisfies this regime — the separation and retention rules have no GMP equivalent to inherit from.
3Hold Schedule I and II records physically separate from everything else; this is prescriptive, and a risk rationale will not substitute.
4Test retrieval against a real request and record how long it took — readily retrievable is a requirement records must meet, not a description.
5Diarise the biennial inventory the moment the current one closes, because an inventory that was never taken cannot be reconstructed later.
6Investigate an inventory discrepancy as a possible diversion before reconciling it; reconciling first destroys the only signal you had.
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Scope and the Regime This Sits In
2Inventory
3Record Separation by Schedule
4Readily Retrievable
5Accountability for Every Unit
6Physical Security Alongside the Records
REGULATORY CONTEXT

21 CFR Part 1304 sets the recordkeeping requirements for registrants, including the initial and biennial inventories, separation of records by schedule, and retention in a readily retrievable form. It is a diversion-control regime rather than a product-quality one, and carries no mutual-recognition equivalence — compliance elsewhere transfers nothing into it. What counts as an acceptable retrieval time, and which discrepancies warrant a diversion enquiry, are determinations your organisation makes and defends. The procedure structure is SPEQ practitioner synthesis.

MAPPED STANDARDS
21 CFR Part 1304
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