The three-layer baseline
Registration facts, activities, suppliers, responsible persons, security, inventories, loss, disposal and records.
Identity, quality, purity, strength, raw-material control, manufacturing evidence and product-development records where applicable.
The specific state authority, licensed activities, site, conditions, traceability and operating requirements.
DEA application readiness record
Renee's blueprint is translated into an evidence-backed workspace with the following controlled sections:
- Entity and registered locationLegal name, EIN, physical site, mailing address and exact license-name reconciliation.
- Point of contact and activitiesAuthorized contact, requested drug/activity codes and medical-versus-adult-use separation.
- State-license exhibitsAuthority, license number, scope, issue/expiry dates, status and source document.
- Suppliers and repackagingQualified counterparties, registration facts, product flow and relabeling/repackaging scope.
- Control persons and personnelOwnership, actual control, operational access, authorizations, disclosures and reviewer notes.
- Security and attestationBuilt controls, evidence references, exceptions, signature authority and frozen submission copy.
cGACP inputs to cGMP manufacture
FDA's Botanical Drug Development guidance recognizes that botanical quality control starts with the raw material and that, in some cases, both GACP and CGMP controls may be warranted across growing, collection, processing and storage. The U.S. data model therefore preserves the handoff instead of treating cultivation and manufacturing as disconnected systems.
Canadian GACP/GMP experience is used as comparative implementation guidance. U.S. applicability remains anchored to the cited FDA, DEA and state source.
Controlled SOP library
Each SOP is versioned, assigned, trained, approved and reviewed. A checkbox can only point to a current, operating control - not a future intention.
Official federal starting points
- DEA marijuana rescheduling regulatory actionsCurrent DEA notices, rulemaking and medical-dispensary registration entry.
- 91 FR 22714 - final rulePublished federal rule and affected parts of title 21.
- FDA cannabis quality considerationsCMC and quality guidance for cannabis-related clinical drug development.
- FDA Botanical Drug Development guidanceRaw-material, GACP, CGMP and botanical-drug development considerations.
- 21 CFR part 1301DEA registration regulations. Verify the current eCFR text at the time of use.