Source, Labeling, and Governance Boundaries

Last reviewed: 2026-07-23

General source rule

Sources support provenance; they do not authorize the agent to make a clinical decision. A current source may still be inapplicable to a specific person, setting, product, formulation, route, indication, jurisdiction, or institution.

Only an authorized licensed professional may:

• decide whether a source applies;
• interpret a label, Medication Guide, REMS requirement, guideline, policy, or standard;
• resolve conflicts among sources;
• convert source content into a patient-specific decision;
• determine whether a requirement was satisfied.

The package stores the professional's verified decision and source locator. It does not reproduce a recommendation from the source.

FDA prescribing information

FDA's human prescription-drug labeling resources distinguish FDA-approved labeling from other "current" or "in use" labeling. FDA states that Drugs@FDA contains the most recent CDER-approved Prescribing Information and patient labeling for covered products, while other databases may include company-submitted changes under review.

For an already selected medication, the authorized clinician or pharmacist must verify, as applicable:

• exact product, application, formulation, route, and strength;
• current FDA-approved Prescribing Information;
• current FDA-approved patient labeling;
• current safety-related labeling changes;
• local formulary and institutional policy;
• whether a product is outside the scope of Drugs@FDA and requires another authoritative FDA source.

This skill records fact IDs and verification. It must not search for a product while processing real-patient content, interpret sections, compare alternatives, or decide dosing, contraindications, interactions, monitoring, or eligibility.

Medication Guides and patient labeling

FDA-approved patient labeling includes Medication Guides, Patient Package Inserts, and Instructions for Use. FDA notes that not every prescription drug has FDA-approved patient labeling and that consumer medication information developed outside the applicant is not reviewed or approved by FDA.

Do not:

• invent or paraphrase a Medication Guide as patient instructions;
• assume a generic consumer handout is FDA-approved;
• omit a required current document based on a template;
• decide whether a risk changes treatment.

Record only which current material the authorized clinician or pharmacist verified and where it is held in the local system.

REMS

REMS are product-specific safety programs. FDA explains that participant roles, communications, required activities, certifications, enrollment, monitoring, and safe-use conditions vary by medication. Current requirements and materials are maintained in REMS@FDA.

The package may document:

• whether an authorized reviewer checked REMS@FDA;
• the REMS material version/date and local locator;
• the participant role and requirement as already verified;
• completion status recorded by the authorized local process.

The skill must not decide whether a REMS applies, enroll anyone, certify a prescriber or site, interpret a safe-use condition, or determine whether prescribing or dispensing may proceed.

WHO and Joint Commission process guidance

WHO transition guidance supports process concepts such as:

• timely and accurate transfer of information;
• medication reconciliation at transitions;
• patient and carer involvement;
• explicit ownership and follow-up;
• standardized terminology, checklists, and tracking.

Joint Commission materials similarly emphasize reliable identification, handoff communication, and continuity. Use these sources only to structure documentation and local governance.

Do not copy proprietary standards, claim accreditation compliance, or convert process guidance into patient-specific content. The current institution policy controls.

CMS boundary

CMS publishes person-centered care concepts and program-specific documentation requirements. Requirements vary by program, provider type, setting, state, contract, and date.

Do not treat a CMS innovation concept, job aid, measure, billing rule, or conditions-of-participation excerpt as a universal treatment-plan requirement.

Before recording a CMS requirement, the authorized compliance owner must identify:

• exact program and authority;
• current effective version;
• provider and setting applicability;
• state or contractor variation;
• local policy implementation.

The skill does not support coding, billing-level selection, medical-necessity decisions, or reimbursement claims.

Local and professional guidance

The responsible clinician must use:

• current institution-approved clinical guidance;
• current specialty guidance appropriate to the case;
• current product-specific information;
• current jurisdictional and scope-of-practice rules;
• current professional judgment and approved systems.

This repository intentionally contains no disease-specific treatment recommendations or specialty schedules. Do not add them to templates, tests, examples, or references.

Reporting and governance

The package records local routes; it does not submit reports.

Potential routes may include:

• local patient-safety or quality reporting;
• local pharmacy/medication-safety review;
• FDA MedWatch for medical-product events when the responsible reporter determines it applies;
• privacy/security incident response and HHS OCR breach reporting when qualified personnel determine it applies;
• AHRQ Common Formats within an authorized Patient Safety Organization workflow.

Never decide reportability, causality, seriousness, legal duty, deadline, recipient, or content. Never transmit patient data from a bundled script.

Currency control

At each authorized revision:

1. Verify source currency in an approved workflow.
2. Record source version or content date.
3. Record who verified applicability and when.
4. Preserve the prior local record as policy requires.
5. Re-run structural and traceability checks.
6. Obtain new sign-off if a governing source changed.

The dated ledger in source_ledger.md documents the process sources used to design this skill. It is not a substitute for current case-specific review.