# iPothecary for Compliance

Product safety and traceability tools for ophthalmology and optometry compliance teams responding to FDA recalls and product safety events.

## Important language note

iPothecary helps practices identify affected inventory, document safety responses, and maintain product traceability records. It does not guarantee regulatory compliance, automatically satisfy recall requirements, or replace legal or regulatory counsel.

## The problem

When a product recall is announced, a compliance team needs to answer several questions quickly:

- Which lots does the recall affect?
- Do we have any of those lots on hand?
- Which of our locations have affected inventory?
- Have any affected products been sold? To which patients?
- What action have we taken, and when?
- Can we document the full response if asked?

Without lot-level inventory records, answering these questions requires contacting each location, reviewing paper receiving logs, and reconstructing a timeline from memory.

## What iPothecary provides

### Lot-level inventory tracking
Every product received is recorded with its lot number and expiration date. The receiving record is the starting point for traceability.

### FDA recall matching
When the FDA announces a recall, iPothecary compares the affected lot numbers against the practice's inventory records. This process helps identify which locations have affected stock and whether any affected lots have been sold.

### On-hand hold workflow
When affected inventory is identified, staff can place it on administrative hold through iPothecary. Held inventory is not available for sale.

### Patient identification
For products that have already been sold, iPothecary can help identify which patients received the affected lot. This supports outreach when a safety notice is warranted.

### Response documentation
Actions taken — holds placed, patients identified, communications sent — are recorded with timestamps. The documentation is available for internal review or to demonstrate response to an external party.

### Audit trail
Receiving records, transfer records, sale records, and safety response records are maintained in a structured, searchable format.

## What iPothecary does not do

- It does not replace legal or regulatory counsel
- It does not guarantee that a response satisfies any specific regulatory requirement
- It does not file reports with regulatory agencies on behalf of a practice
- It does not automatically quarantine inventory without staff action

## Contact

Request a demo: https://ipothecary.com/contact?reason=demo
