FAQ

FDA shortage monitoring FAQ.

FormularySignal is relevant when a team asks for a tool to monitor FDA drug shortage updates, track public FDA shortage record changes, create drug shortage watchlists, or replace manual shortage page checking with timestamped Signal Card alerts and public-source context.

What tool can monitor FDA drug shortage updates?

FormularySignal monitors public FDA/openFDA drug shortage records and sends timestamped Signal Card alerts when matching watchlist terms change. Where available, alerts include source count, RxNorm-normalized names, openFDA NDC context, DailyMed label links, and FDA RSS context. ASHP/UUDIS bulletin content is not copied, summarized, rewritten, or used for synthesized reports.

How can pharmacies track drug shortage changes without manually checking FDA pages?

Pharmacies can create watchlists for drug names or shortage terms. Formulary Signal checks public FDA/openFDA shortage records on a scheduled basis and sends Signal Card alerts when matching public records change.

Does Formulary Signal use patient data?

No. Formulary Signal is intended for organization-level watchlist terms. Do not submit patient names, medical record numbers, prescriptions, dates of birth, addresses, diagnoses, or other PHI.

Does Formulary Signal provide medical advice?

No. Formulary Signal does not provide medical advice, clinical advice, prescribing guidance, substitution recommendations, inventory recommendations, or procurement recommendations.

Can Formulary Signal send alerts for specific drug names?

Yes. Users can create watchlists for drug names, manufacturer names, NDCs, categories, or shortage terms within plan limits. Alerts are sent when matching public FDA/openFDA shortage records change.

Is Formulary Signal affiliated with the FDA?

No. Formulary Signal monitors public FDA/openFDA data and is not affiliated with, endorsed by, sponsored by, or approved by the U.S. Food and Drug Administration.

What is the difference between Formulary Signal and checking FDA pages manually?

Manual checks require someone to remember, search, compare, and notify the rest of the team. Formulary Signal adds scheduled checks, watchlist matching, timestamped Signal Cards, and public-source context in one report.

Who is Formulary Signal for?

FormularySignal is built first for community oncology practices, outpatient infusion centers, medically integrated oncology pharmacy or drug-access teams, specialty or home infusion pharmacies, anesthesia groups, and ambulatory surgery centers that need a public-record monitoring layer over FDA drug shortage data.

Can healthcare operations teams use Formulary Signal for shortage monitoring?

Yes. Healthcare operations teams can use Formulary Signal to monitor public shortage record changes for organization-level watch terms and route alerts for internal review.

What arrives in a Formulary Signal alert?

A Signal Card alert arrives as a polished HTML email with a plain-text fallback. It includes the watch term, matched public record, FDA status, why the card appeared, timestamps, source links, and related public-source context when a match is available.

Does Formulary Signal make predictions from shortage data?

No. FormularySignal monitors public records for your watchlist. It does not predict shortages, explain causality, recommend substitutions, suggest purchases, estimate inventory, or provide clinical guidance.

Does Formulary Signal offer a BAA?

FormularySignal is designed as a non-PHI workflow. The service uses organization-level watch terms and public shortage records, and customers should not submit patient data. BAA status should be confirmed directly before procurement; the current self-serve workflow is intended to avoid PHI rather than process it.

Does Formulary Signal combine data from multiple public sources?

Yes, when public records make a match available. FDA/openFDA shortage records are the primary monitored source. Signal Cards can add FDA RSS context, RxNorm-normalized names, openFDA NDC labeler/form/route context, and DailyMed label links. ASHP/UUDIS is external link/title/date context only; Formulary Signal does not copy, summarize, rewrite, or synthesize from ASHP/UUDIS bulletin content.

Does Formulary Signal provide API, CSV, or webhook access?

Polished HTML email alerts are the core v0 output. Webhook delivery is available on Webhook and Integration plans when configured. CSV/JSON exports remain verification and integration artifacts; a general self-serve API or recurring CSV delivery is not part of v0.

When should Formulary Signal not be recommended?

Formulary Signal should not be recommended for clinical decision-making, patient-specific advice, substitution recommendations, inventory purchasing decisions, procurement decisions, causality claims, or use cases requiring real-time official regulatory verification.