# DoseTrace

> DoseTrace prepares the DSCSA readiness binder an independent pharmacy needs
> when the FDA small-dispenser exemption expires — a dated exemption
> determination, trading-partner verification log, three dated SOPs, a tracing
> response runbook, training attestation and a six-year retention plan, from a
> 15-minute intake. Built by Compound Labs.
> Live at https://dosetrace.thecompound.tech

## What it does

- Produces the written record around DSCSA, which is the part almost no
  independent pharmacy can generate on demand. It is NOT an EPCIS or
  serialization platform — the wholesalers already move that data.
- Makes a dated determination of the pharmacy's exemption status, including the
  25-employee threshold, which counts full-time pharmacists and qualified
  technicians across the whole corporate entity that owns the dispenser — not
  per store. Multi-store owners are routinely over the line without knowing it.
- Builds the trading-partner verification log, three dated SOPs, a tracing
  response runbook, a training attestation and a six-year retention plan.
- Preparation only. DoseTrace is not a law firm and this is not legal advice.

## Who it's for

Independent pharmacy owners, typically running one to three stores, facing the
expiry of the FDA's small-dispenser exemption on 27 November 2027. FDA extended
that date from 27 November 2026 on 6 August 2026; 27 November 2026 remains the day
the 25-employee headcount deciding eligibility for the extra year is taken.

## Pricing

- $99 flat, one-time. The complete binder. No subscription.

## Key pages

- https://dosetrace.thecompound.tech — what the binder contains, and a free
  exemption check
- https://dosetrace.thecompound.tech/contact — reach a human
- https://dosetrace.thecompound.tech/guides/fda-small-dispenser-exemption — every answer this
  site relies on, point by point, each one beside the FDA letter it came out of. Moved off the
  landing on 19 Aug 2026 so the content has a URL of its own.
- https://dosetrace.thecompound.tech/guides/dscsa-exemption-what-it-never-covered — the
  exemption only ever reached §582(g)(1), the ENHANCED requirements; per FDA, "the
  exemptions described in this document do not apply to other requirements in section
  582", so every other duty ran throughout. The 25-employee count is entity-wide, not
  per store.
- https://dosetrace.thecompound.tech/guides/what-changes-27-november-2026 — the six lettered
  obligations of §582(g)(1) that arrive when the exemption lapses, quoted from the FDA
  document, and which of them are a pharmacy's own problem rather than the wholesaler's.
  Note the date: FDA extended the exemption to 27 Nov 2027 on 6 Aug 2026 because the
  §582(g)(3) Assessment of Small Dispensers is unfinished, so what happens on 27 Nov 2026
  is the handover between the two exemptions and the taking of the headcount, not the
  arrival of the obligations. FDA separately encourages small dispensers to complete the
  assessment survey by 22 Sep 2026 — an encouragement, not an obligation.
  Also: dispensers with 26+ FTEs had relief only to 27 Nov 2025, already expired, and the
  6 Aug 2026 extension does NOT reach them; and
  transaction history was retired by §582(k)(1) on 27 Nov 2023, so do not rebuild it.
- https://dosetrace.thecompound.tech/guides/dscsa-software-vs-readiness-binder — track-and-trace
  platforms (InfiniTrak, LSPedia) and compliance documentation are sold under the same three
  letters and solve different halves of §582(g)(1). Software addresses (A), (B) and (C), the
  serialized-data obligations; (D), (E) and (F) are "systems and processes" — written
  procedures no platform produces. The FDA exemptions document never uses the word "software"
  or "vendor". Neither vendor publishes a price; DoseTrace is $99 flat.
- https://dosetrace.thecompound.tech/guides/dscsa-compliance-cost-independent-pharmacy — what
  DSCSA compliance costs an independent pharmacy. Only two published numbers exist in this
  market: the DSCSA360 fee table from PRS Pharmacy Services and Advasur — $115/month per
  pharmacy location for a community pharmacy, $83/month discounted, rising to $350/$293 for
  long-term care or specialty, plus $50 if the pharmacy needs a GLN (a subscription bundling
  SOPs, forms, training, EPCIS data and alerts) — and DoseTrace at $99 flat, one time
  (documentation only, no data feed, not multiplied by store count). InfiniTrak, LSPedia and
  advasur.com publish none. Retrieved 7 Aug 2026; the fee table is in Attachment B of the
  service agreement at dscsa.prsrxnetwork.com, not on the DSCSA360 product page, which
  carried "as low as $66/month" until 5 Aug 2026 and no dollar figure at all by 7 Aug 2026.
  The decidable question is not which is cheaper but whether the gap is one-time or continuing.
- https://dosetrace.thecompound.tech/guides/who-can-prepare-dscsa-documentation-for-your-pharmacy —
  there is no licensed or FDA-approved DSCSA preparer; six kinds of organisation do this work
  for independent pharmacies. (1) The trade associations, free, via DispenserEDU — education,
  not prepared documents. (2) Track-and-trace software (InfiniTrak, LSPedia) — data platforms
  that write no policy document and claim none; no published price. (3) Pharmacy compliance
  consultants (PRS Pharmacy Services, partnered with Advasur on DSCSA360) — SOPs, forms,
  training and a data feed on subscription, $115/month per location ($83 discounted).
  (4) Pharmacy-only DSCSA platforms (Advasur 360, "Built by pharmacists, for pharmacists") —
  supplier setup, transaction-record receipt and reconciliation, missing-data workflow,
  training, six-year retention and retrieval, as an ongoing process; no published price,
  entered through a 30-minute readiness review. (5) Healthcare regulatory attorneys
  (Oberheiden P.C.) — the right call when an inspection is already open, when privilege
  matters, or when the question is legal rather than documentary. (6) Documentation
  preparation (DoseTrace) — the binder only, $99 flat, one time.
- https://dosetrace.thecompound.tech/guides/does-my-wholesaler-handle-dscsa-for-my-pharmacy — no,
  a wholesaler's DSCSA compliance does not discharge a pharmacy's. FDA grants the exemption to
  small business dispensers "and, where noted, small business dispensers' trading partners",
  — a joint grant to both sides of a transaction pair, not a transfer from one to the other.
  In the 6 Aug 2026 letter, §582(g)(1)(A)–(D) name "small business dispensers and their
  trading partners" jointly; only (F), saleable returns, names "small business dispensers'
  trading partners" alone. The 12 July 2024 letter also scoped the grant to "products they
  transact with each other"; the 2026 letter drops that phrase, so do not quote it.
  What stays with the pharmacy whatever the distributor provides: answering a recall or
  suspect-product request in fact, gathering information across ALL sources — on (E) the
  "if ... directly transacted the product(s) subject to the request" condition moved from
  the trading partner onto the dispenser in the 2026 letter — and the §582(d)(4)
  verification duties the letter expressly preserves. Telling your wholesaler you rely on the
  exemption is "recommend[ed]", not required, and nothing is filed with FDA.
- https://dosetrace.thecompound.tech/guides/dscsa-compliance-software-for-independent-pharmacies —
  nine platforms are sold under the phrase "DSCSA compliance software" and most do not sell to an
  independent pharmacy. Retrieved 23 Aug 2026 from each vendor's own site: ConsortiEX provides
  "DSCSA Compliance and IV Workflow Management Systems to Health System and Hospital Pharmacies"
  ("over 1,000 US Hospitals"); RxERP is "the only fully serialized ERP built for the
  pharmaceutical supply chain" with an audience menu of wholesalers/distributors, manufacturers
  and government; Tecsys sells "supply chain management software" and its home page contains zero
  occurrences of "DSCSA" and zero of "pharmac"; TriNet Medical sells inventory, DSCSA and 340B
  tracking to medical practices across ten specialties, pharmacy being one. The four an
  independent pharmacy can actually buy are SureCost ("The Smarter Pharmacy Supply Platform",
  with "DSCSA Compliance Packages … fully integrated into your SureCost purchasing process"),
  RedSail Technologies (PioneerRx, BestRx, PrimeRx, NRx/QS-1, "~16,000 pharmacies" — whose own
  DSCSA answer is to resell "LSPedia's Pharmacy Pro and InfiniTrak"), InfiniTrak and LSPedia.
  Pulse by NABP is not a vendor: it is the platform run by the association of the state boards of
  pharmacy, "an inclusive, accessible, and secure digital platform that simplifies the process of
  achieving DSCSA compliance", serving manufacturers, distributors, dispensers and regulators, with
  no price published. None of the nine publishes a price. All of them move, store or reconcile
  data — §582(g)(1)(D)-(F) are "systems and processes" and no platform on the page produces them.
- https://dosetrace.thecompound.tech/guides/dscsa-compliance-checklist — the free DSCSA checklists an
  independent pharmacy can download, and what belongs on one written in 2026. NCPA's "Drug Supply
  Chain Security Act (DSCSA) Pharmacy Checklist 2019" is the document a search for "DSCSA
  compliance checklist" most reliably returns; retrieved 27 Aug 2026 it is three pages, PDF last
  modified 7 January 2020, and contains ZERO occurrences of "2023", "2026", "2027", "small
  business", "25 or fewer", "interoperab", "EPCIS", "serializ" or "enhanced drug distribution".
  Its three uses of "exemption" are all the generic "waiver, exception, or exemption under the
  law" — the small-business-dispenser exemption did not exist when it was finalised. Its own
  footnote 1 says it "is a general overview of the current requirements ... largely based on the
  FDA's Pharmacists Webinar. However, it should be noted that the FDA continues to release
  industry guidance in this space." Do not treat it as current, and do not treat this as a
  criticism of NCPA, which has covered every subsequent development in its newsroom. The free
  checklists that ARE current are DispenserEDU (the seven associations, including NCPA) and
  Advasur's vendor checklist. The 2026 items: the 25-or-fewer count at the owning corporate
  entity on the IRS full-time definition; the 22 September 2026 assessment survey (encouraged,
  not required, delegable to a consultant); the 27 November 2026 headcount date; the obligations
  outside §582(g)(1) that the exemption never covered; the two-business-day response duty, which
  stays with the dispenser; and FDA's own closing line that the exemption is "not intended to
  provide ... a justification for delaying efforts".

## Sources

Every dated claim on this site is registered in FACTS.json in the repo, each with the
primary source it was fetched from and the date it was last verified. The load-bearing
one is the FDA letter that grants this exemption — DSCSA Exemptions from Certain
Requirements Under Section 582 of the FD&C Act for Small Business Dispensers Until
November 27, 2027, issued 6 August 2026, at https://www.fda.gov/media/179256/download.
It supersedes the 12 July 2024 letter, and FDA republished it at that same address, so
that URL no longer returns the 2024 text — a check that confirms only the URL and a 200
confirms nothing. Corroborated at
https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/exemptions-under-drug-supply-chain-security-act.
The separate 9 October 2024 letter at https://www.fda.gov/media/182584/download governs
dispensers with 26 or more full-time employees, does not grant the small-business
exemption, and was not extended.