The DSCSA record an inspector reads.

Nine documents, prepared for your pharmacy from a fifteen-minute intake: the dated exemption determination, your trading-partner verification log, three SOPs, a tracing response runbook, staff training attestations and a six-year retention plan. $499 flat.

Are you still exempt, and what changes on 27 November 2026?

Count the licensed pharmacists and technicians the whole corporate entity employed on 27 November 2024 — FDA freezes the count at that date. Full-time means the IRS test: averaging 30+ hours a week, or 130 hours a month.

Three things an
inspector asks for.

One intake.
Every document, dated.

A pharmacy owner answering intake questions on a laptop at a back-office desk

Fifteen minutes of questions

We ask what an inspector would: who licenses you, how many pharmacists and technicians the entity employs, which wholesalers you buy from, and who is on staff. Nothing you have to research first.

A pharmacy owner answering intake questions on a laptop at a back-office desk

Fifteen minutes of questions

We ask what an inspector would: who licenses you, how many pharmacists and technicians the entity employs, which wholesalers you buy from, and who is on staff. Nothing you have to research first.

A pharmacy owner answering intake questions on a laptop at a back-office desk

Fifteen minutes of questions

We ask what an inspector would: who licenses you, how many pharmacists and technicians the entity employs, which wholesalers you buy from, and who is on staff. Nothing you have to research first.

A stack of freshly printed documents on a pharmacy counter under the owner's hand

Nine documents, written for your pharmacy

Your name, your licence number, your wholesalers, your staff — on every page, with the date you were assessed. Blank templates from a trade association are not a record; a specific dated set about your pharmacy is.

A stack of freshly printed documents on a pharmacy counter under the owner's hand

Nine documents, written for your pharmacy

Your name, your licence number, your wholesalers, your staff — on every page, with the date you were assessed. Blank templates from a trade association are not a record; a specific dated set about your pharmacy is.

A stack of freshly printed documents on a pharmacy counter under the owner's hand

Nine documents, written for your pharmacy

Your name, your licence number, your wholesalers, your staff — on every page, with the date you were assessed. Blank templates from a trade association are not a record; a specific dated set about your pharmacy is.

A pharmacist signing a printed attestation page at their counter

You sign it, date it and file it

Print it and put it behind the counter. Three things are yours to finish: fill the fields only your wholesaler can answer, sign the training attestation, and run the tracing dry run and write down the date.

A pharmacist signing a printed attestation page at their counter

You sign it, date it and file it

Print it and put it behind the counter. Three things are yours to finish: fill the fields only your wholesaler can answer, sign the training attestation, and run the tracing dry run and write down the date.

A pharmacist signing a printed attestation page at their counter

You sign it, date it and file it

Print it and put it behind the counter. Three things are yours to finish: fill the fields only your wholesaler can answer, sign the training attestation, and run the tracing dry run and write down the date.

Nine documents.
Every one of them dated.

See a sample binder

Nine documents.
Every one of them dated.

See a sample binder

Determination

Where you stand, in writing and dated.

Exemption determination

Your status, the basis for it, and what changes on 27 November 2026.

Counted the right way

Pharmacists and technicians across the whole entity, not one store.

Signed by you

You attest to the determination, on a date an inspector can read.

A pharmacy owner reading a printed determination page in the window light
A technician checking sealed wholesaler totes against a clipboard of delivery paperwork
Two pharmacy staff reviewing a printed procedure together at the dispensing bench
Labelled archive box files on a shelf in a pharmacy back office

Determination

Trading partners

The SOPs

Response & retention

Where you stand, in writing and dated.

Exemption determination

Your status, the basis for it, and what changes on 27 November 2026.

Counted the right way

Pharmacists and technicians across the whole entity, not one store.

Signed by you

You attest to the determination, on a date an inspector can read.

A pharmacy owner reading a printed determination page in the window light
A technician checking sealed wholesaler totes against a clipboard of delivery paperwork
Two pharmacy staff reviewing a printed procedure together at the dispensing bench
Labelled archive box files on a shelf in a pharmacy back office

Determination

Trading partners

The SOPs

Response & retention

Where you stand, in writing and dated.

Exemption determination

Your status, the basis for it, and what changes on 27 November 2026.

Counted the right way

Pharmacists and technicians across the whole entity, not one store.

Signed by you

You attest to the determination, on a date an inspector can read.

A pharmacy owner reading a printed determination page in the window light
A technician checking sealed wholesaler totes against a clipboard of delivery paperwork
Two pharmacy staff reviewing a printed procedure together at the dispensing bench
Labelled archive box files on a shelf in a pharmacy back office

What this is, and what it is not.

A binder that overstates what it covers is worse than none, so here is the boundary in plain terms.

Not an EPCIS platform

We do not move serialization data — your wholesalers do. This is the written record around it.

Not legal advice

It is compliance documentation. You are attesting to it, so read it before you sign it.

We refuse when we should

No wholesalers to log, or over the 25-FTE line? The job stops and a person writes the review.

Six years, per wholesaler

The retention plan names where each wholesaler's data lives and how long they keep it.

Not an EPCIS platform

We do not move serialization data — your wholesalers do. This is the written record around it.

Not legal advice

It is compliance documentation. You are attesting to it, so read it before you sign it.

We refuse when we should

No wholesalers to log, or over the 25-FTE line? The job stops and a person writes the review.

Six years, per wholesaler

The retention plan names where each wholesaler's data lives and how long they keep it.

Not an EPCIS platform

We do not move serialization data — your wholesalers do. This is the written record around it.

Not legal advice

It is compliance documentation. You are attesting to it, so read it before you sign it.

We refuse when we should

No wholesalers to log, or over the 25-FTE line? The job stops and a person writes the review.

Six years, per wholesaler

The retention plan names where each wholesaler's data lives and how long they keep it.

Simple pricing.
No surprises.

You have questions.
We have answers.

Is this an EPCIS or serialization platform?

No, and it does not try to be. Your wholesalers move the serialization data. What almost no independent pharmacy can produce on the spot is the written record around it — the dated determination, the verified partner log, the procedures and the retention plan. That is what this is.

What counts toward the 25-employee threshold?

Full-time employees licensed as pharmacists or qualified as pharmacy technicians, counted across the whole corporate entity that owns the dispenser — not per store. Multi-store owners routinely count one location and believe they qualify. The free checker above is built around exactly this.

What happens on 27 November 2026?

FDA's exemption for small dispensers from the enhanced drug distribution security requirements of section 582(g)(1) expires. The exemption only ever covered the enhanced, electronic and interoperable requirements — knowing your authorized trading partners, keeping transaction information, handling suspect product and answering a tracing request have applied the whole time.

How much work is this for me?

About fifteen minutes of questions, then the binder comes back to you. Three things stay yours: fill in the fields only your wholesaler can answer, sign the training attestation, and run the tracing dry run and write down the date. An unsigned attestation is worse than none.

Is this legal advice?

No. It is compliance documentation, prepared from your answers. You are attesting to its contents, so read it before you sign it and correct anything that does not match how your pharmacy actually operates.

Why a flat fee instead of a subscription?

Because the deadline could move. A subscription priced against a date that shifts is how you end up owing refunds. $499 once, for a binder you own.

Is this an EPCIS or serialization platform?

No, and it does not try to be. Your wholesalers move the serialization data. What almost no independent pharmacy can produce on the spot is the written record around it — the dated determination, the verified partner log, the procedures and the retention plan. That is what this is.

What counts toward the 25-employee threshold?

Full-time employees licensed as pharmacists or qualified as pharmacy technicians, counted across the whole corporate entity that owns the dispenser — not per store. Multi-store owners routinely count one location and believe they qualify. The free checker above is built around exactly this.

What happens on 27 November 2026?

FDA's exemption for small dispensers from the enhanced drug distribution security requirements of section 582(g)(1) expires. The exemption only ever covered the enhanced, electronic and interoperable requirements — knowing your authorized trading partners, keeping transaction information, handling suspect product and answering a tracing request have applied the whole time.

How much work is this for me?

About fifteen minutes of questions, then the binder comes back to you. Three things stay yours: fill in the fields only your wholesaler can answer, sign the training attestation, and run the tracing dry run and write down the date. An unsigned attestation is worse than none.

Is this legal advice?

No. It is compliance documentation, prepared from your answers. You are attesting to its contents, so read it before you sign it and correct anything that does not match how your pharmacy actually operates.

Why a flat fee instead of a subscription?

Because the deadline could move. A subscription priced against a date that shifts is how you end up owing refunds. $499 once, for a binder you own.

Is this an EPCIS or serialization platform?

No, and it does not try to be. Your wholesalers move the serialization data. What almost no independent pharmacy can produce on the spot is the written record around it — the dated determination, the verified partner log, the procedures and the retention plan. That is what this is.

What counts toward the 25-employee threshold?

Full-time employees licensed as pharmacists or qualified as pharmacy technicians, counted across the whole corporate entity that owns the dispenser — not per store. Multi-store owners routinely count one location and believe they qualify. The free checker above is built around exactly this.

What happens on 27 November 2026?

FDA's exemption for small dispensers from the enhanced drug distribution security requirements of section 582(g)(1) expires. The exemption only ever covered the enhanced, electronic and interoperable requirements — knowing your authorized trading partners, keeping transaction information, handling suspect product and answering a tracing request have applied the whole time.

How much work is this for me?

About fifteen minutes of questions, then the binder comes back to you. Three things stay yours: fill in the fields only your wholesaler can answer, sign the training attestation, and run the tracing dry run and write down the date. An unsigned attestation is worse than none.

Is this legal advice?

No. It is compliance documentation, prepared from your answers. You are attesting to its contents, so read it before you sign it and correct anything that does not match how your pharmacy actually operates.

Why a flat fee instead of a subscription?

Because the deadline could move. A subscription priced against a date that shifts is how you end up owing refunds. $499 once, for a binder you own.