503A pharmacies: Receive, release and recall, with the proof on file.
Every certificate read to the line. A Passport with every order.
The release of one batch: nine items on its record, the endotoxin limit from the dose, and the pharmacist's signature. Brennick Compounding is a sample pharmacy; its suppliers, people, lots and figures are invented.
Someone else signed the certificate. You sign the release.
Section 503A requires a valid certificate of analysis with every bulk drug substance. Veritura checks each one, so when the board inspector asks who checked it, and against what, the answer is on the record.
United States Code21 U.S.C. §353a(b)(1)(A)(iii)
… accompanied by valid certificates of analysis for each bulk drug substance …
NABPJuly 29, 2026
… the difficulty of verifying the bulk substances from which compounded medications are made …
Eight jobs you already answer for. Each one kept as you do it.
Each on the screen where it happens, drawn from the product on a sample workspace. Veritura holds what fails. The pharmacist decides.
Receive and checkEvery certificate read to the line and held to the 503A routes, FDA's lists and your dose.
Emailed, dropped in or sent through the supplier's link, then fingerprinted and filed to its lot.
The three 503A routes and FDA's four lists, checked per substance and dated as printed. Category 2 holds the lot in every policy: a floor, not a setting.
Read from the record, never a checkbox: label against paperwork, certificate, supplier file, results, container dating, temperature, FDA source screen.
Sign the dispositionFour verdicts, your signature, and the reason kept.
Verified, Verified where checked, Your call, or Not verified, each naming its checks.
The printed name, the time and a fixed meaning. An edited signature breaks the chain.
Nothing leaves a lot until a named person has reviewed it, on every path. A signature never clears a finding.
Issue a Passport with every orderWho made it, what the lab found and who released it, for the clinic and the patient.
One Passport per dispensed order, issued from a lot a named person reviewed. A lot number that matches several lots is refused.
Fourteen fields from a fixed list, each ingredient with its lot and results, and a fingerprint anyone can recompute. Never a score, never anyone's identity.
The binding is never rewritten. A recall months later still marks every Passport issued from the lot.
Answer a recallA supplier's notice matched to your batches, your Passports and the clinics holding units.
A supplier's notice arrives by its door, by email to your workspace's address, or typed in. Lots on file are re-matched against FDA's enforcement records every hour.
One recall on the batch reaches every clinic on Veritura holding units, on its own desk, and marks every Passport issued from it.
A quality event opens with its reporting deadline and the rule it comes from. Each step owed has an owner and a due date.
Keep the supplier fileSix dated elements, an owner for every gap, a free link for suppliers.
What a board inspector asks for: each element current, due or overdue, every gap owned and dated.
Drafted from the gap, sent by a person, answered through a link and read again on arrival.
Three outcomes, signed by a named person. Qualified is refused while a gap is open.
Keep the record partners readLicenses, inspections and statements, checked at source, shown to the clinics and platforms you choose.
Each line read from the source it names, such as NPPES. A line that differs says so, and never which one is right.
The full record, an insurer's checklist, a license section, a telehealth partner's form and a payer audit.
Nothing is shared until you create a link. Each names who it is for and stops at once when you close it. No pharmacy can pay to change its record.
Rehearse the inspectionCato walks your records in a surveyor's order, sterile records included.
Cato states his scope, then walks five areas in the order a surveyor asks.
Confirmed by a person, checked by Veritura, shown in person, still to collect, missing.
Media fills, smoke studies and environmental samples, read against USP <797> and the faults FDA named on September 18, 2026.
Keep the copy fileEach order compared with what FDA lists as marketed, the prescriber's words on file.
The prescriber signs their own determination from a link. Veritura records it and never offers a statement.
Each order compared with FDA's marketed products: same ingredient, strength within 10%, same route.
Orders and the prescriber's words stay in your browser and a file you save, never on our server.
Line 11 named the seller, not the maker. The lot waited for a pharmacist.
Lot BM-5520, Cyanocobalamin USP from Brookmere API Supply, on a sample workspace, from a 2:09 am arrival to a signed release on Oct 6. Every firm, lot and person is fictional.
Emailed to the workspace's own address, kept exactly as received and fingerprinted.
11 of the twenty named checks apply. Line 11 names the seller, not the original manufacturer the statute asks for. The lot is held.
Vera, the AI colleague, drafted the request overnight. Dana Reyes, PharmD read and sent it.
The corrected certificate names the maker, Halden Fine Chemicals, registered to manufacture. The review runs again on its own.
Dana Reyes, PharmD signs the release, reason kept. On Oct 7 the lot becomes batch CB-2026-1007-01, and each order gets a Passport.
Open the Passport for order ORD-60412Every verdict is a statement about the paperwork; Veritura does not test the substance.
A supplier recalled one ingredient lot. Twenty-five minutes later, four clinics had the notice.
Zinc sulfate USP lot ZS-0442 from Brookmere API Supply, on the same sample workspace, Oct 13. Every firm, lot and person is fictional.
Brookmere API Supply's recall notice for lot ZS-0442 is recorded. A quality event opens: report the product quality issue to the Ohio board by Oct 16, 9:40 am, under Ohio Admin. Code 4729:7-2-03(P).
The record names what reaches it: batch ZN-2026-0929-01, zinc sulfate 1 mg/mL, with 4 Passports out and 4 clinics holding units.
The pharmacy declares the recall once on the batch. It reaches all four clinics on their Veritura desks, 7 units on hand at each: quarantine the units and return them to the pharmacy.
All 4 Passports issued from the batch show the recall on every page. No health information travels with any notice.
Each desk shows the notice not yet opened, so the pharmacy sees who still has to act. Each of the 15 steps owed has an owner and a due date.
Veritura keeps the record of a recall and who it reached. The decision, the return of units and the report to the board stay with the pharmacist.
The printed limit was set for someone else's patient. Yours comes from your dose.
Record the route and largest dose for the preparations you make most. From then on, each certificate is held to the limits that dose allows.
The endotoxin threshold per kilogram, over the most a patient receives per kilogram in an hour.
USP <85>For an intramuscular dose: 5 EU/kg/hr ÷ 0.028571 mg/kg/hr = 175 EU/mg, beside the printed limit.
The 63 solvents of ICH Q3C. A result inside the supplier's limit and over ICH's is caught.
ICH Q3C(R9) · USP <467>Cadmium, lead, arsenic and mercury against the limit for your route, as a share at your dose.
ICH Q3D(R2) · USP <232>Total aerobic count and total yeasts and molds, each against the published criterion.
USP <1111>Without a dose on record, the check says what it needs. It is never counted as passed.
Up to twenty named checks build the verdict. You rule on what they raise.
Each finding cites the page and line it came from. You decide the exceptions the record names, not every line of every certificate.
checks in four groups, each naming the standard it applies
503A routes: a USP or NF monograph, an FDA-approved drug's component, or the bulks list
21 U.S.C. 353a(b)(1)(A)(i)document-integrity signals in every file, for a person, never a verdict
areas Cato walks with your records, in a surveyor's order
Not checked: USP monograph acceptance criteria. Veritura reads whether a certificate claims a monograph, never whether its limits match.
The full detail. Every check, gate and record.
The verdict is built from up to 20 named checks in four groups. On 26 published bulk-substance certificates, 11 to 13 of them came into play, 12 on the median one.
Every check, in the methodologyThe certificate itself
- A valid certificate
- Names the substance and the lot; issued by a named laboratory with a report ID; signed for the quality unit by a person, since ICH Q7 11.43 asks for a person and not a role; addressed to your order. Each element is cited to its page and line, and a role-only sign-off is raised for your call. 21 U.S.C. 353a(b)(1)(A)(iii) · ICH Q7 11.4
- The file itself
- Beside the 20 checks, the file is read as a witness: 17 document-integrity signals, 7 in the file and 10 across your records, beside seven findings from the PDF's own metadata and thirteen signs of a generated document, each a signal for a person and never a verdict.
- The certificate's own numbers
- Dates in a possible order and inside the retest or expiry date; each result against its own printed limit; an assay stated as is, plus the water beside it, cannot exceed the whole sample; a molecular weight that does not belong to its formula. You see the arithmetic, with the lines it came from. ICH Q7 11.41 to 11.42
The substance
- The three 503A routes
- A USP or NF monograph, a component of an FDA-approved drug, or the 503A bulks list, checked per substance: which route applies, or that none does. 21 U.S.C. 353a(b)(1)(A)(i)
- FDA's four 503A lists
- 216.23(a), 216.23(b), Category 1 and Category 2, each name as FDA printed it on May 14, 2026: the list, the entry and its date. The codified lists are re-read from the eCFR every 24 hours. 21 CFR 216.23 · FDA's categories
- Category 1 and Category 2
- A Category 1 substance is shown with the four circumstances of FDA's January 2025 interim policy and the date of FDA's list, and the decision is yours; it never holds a lot. A Category 2 substance holds the lot in every policy, and no setting can switch that off, because the interim policy does not extend to it. Only a substance with none of the three 503A routes holds on every path.
- The monograph claim
- Where a USP or NF monograph exists, whether the certificate states the substance meets it. A missing statement is a decision owed, never a finding. 21 U.S.C. 353a(b)(1)(A)(i)(I)
- The original manufacturer
- Named on the certificate and searched in FDA's establishment registry at read. A firm registered only to relabel or repack does not pass as the maker. You see the registration and FEI, or why not. 21 U.S.C. 353a(b)(1)(A)(ii) · FDA DECRS
- The substance's identity
- Name, UNII, CAS number, formula and molecular weight compared with FDA's substance registry. A conflict fails the verdict with both figures named. FDA GSRS
Limits for your dose
- Bacterial endotoxins
- The limit computed as K / M from your route and maximum hourly dose, then compared with the limit printed: K / M = 5 EU/kg/hr / 0.028571 mg/kg/hr = 175 EU/mg. USP <85>
- Residual solvents
- 63 solvents, each with its permitted daily exposure; with your dose, this substance's share of it. A result inside the supplier's limit and over ICH's is caught. ICH Q3C(R9) · USP <467>
- Elemental impurities
- Cadmium, lead, arsenic and mercury against the limit for your route; with your dose, the share of the permitted daily exposure. ICH Q3D(R2) · USP <232>
- Microbial counts
- Total aerobic count and total yeasts and molds, each against the published criterion. USP <1111> · USP <61>
- Beyond-use dates
- A preparation's beyond-use date against USP's ceiling for its category, storage and sterility testing, and against every ingredient's own expiry: the date that governs, and why. USP <795> · USP <797>
Outside sources
- Enforcement records
- The supplier, the maker and the laboratory searched at read; lots on file re-matched against openFDA enforcement on an hourly cycle. Clear only when the sources answered; a silent source fails closed. openFDA · warning letters · import alerts
- Confirmation from the laboratory
- A request to the issuing laboratory is drafted for you and opens in your own mail; its reply is recorded with where it is kept. Only a recorded reply earns source-confirmed.
- Earlier certificates for the lot
- Two certificates for one lot number that disagree are put side by side: the conflict named, neither document accused.
Receiving, gate by gate
- The gates
- The label against the paperwork, the certificate attached, the supplier file linked, the sterility result, the endotoxin result, the assay against its printed range, container dating, temperature evidence and the FDA source screen.
- Four dispositions
- Release to inventory, quarantine pending evidence, request supplier correction, or hold for a person. An open gate drafts the request to the supplier, naming exactly what is owed for this lot.
- Your release policy
- A preset, Strict, Standard or Lenient, plus named toggles and one threshold, never a free-form rule language.
- The signature
- The printed name, the time and a fixed meaning, bound to the record's fingerprint in one chain per workspace; an edited or removed signature breaks the chain and the page says so. The server refuses a release on every path until a named person has reviewed the lot.
Inspection and sterile records
- Five areas
- Licensure and procedures, rooms and engineering controls, the compounders, the hazardous drug program, and lot and supplier records, in the order a surveyor asks. Cato states the scope first, including what is out of it.
- What software cannot answer
- Twenty-two requests, from garbing to observed aseptic technique, are raised with what will be asked and what a good answer looks like. An observation stays open until it is answered with a name and a date, on a fifteen business day clock.
- Sterile records
- Media fills, smoke studies, certifications, environmental samples and equipment maintenance, read for the faults FDA named in its September 18, 2026 warning letter and against the limits USP <797> sets. Each record holds up, or does not hold up, on a named check, and every earlier version is kept with who changed it, when and why.
- What it does not see
- Veritura reads records. It does not see a hood, a room or a person working, and it never says a facility meets <797>.
Passports and recalls
- The release gate
- A gate on the server, on every path, with eight reasons to refuse a release, among them a recall signal, an open hold, no 503A route and a held or unreviewed ingredient lot. Every refusal names its reason.
- The Passport
- One per dispensed order, signed by a person and bound to its lot for good. The patient reads fourteen fields from a fixed list, every ingredient with its lot, its supplier and its own results, and a fingerprint anyone can recompute.
- A recall
- A supplier's notice by its door, by email or typed in, beside FDA's enforcement records re-matched hourly. Declared once on the batch, it reaches every clinic on Veritura holding units and marks every Passport issued from it.
- The clock
- Each recall opens a quality event with its reporting deadline and the rule it comes from, the steps owed, an owner and a due date for each, and who answers when the reviewer is away.
- Custody
- Seven custody events per unit, from released to reported, each chained to the one before, and a numbered statement per batch: shipped, received, administered, returned and unaccounted.
The copy file
- The rule
- A 503A pharmacy may not compound regularly or in inordinate amounts what is essentially a copy of a commercially available drug, unless the prescriber determines a change makes a significant difference for that patient.
- The comparison
- Each compounded order compared with FDA's marketed products: same ingredient, strength within 10%, same route, per FDA's January 2018 guidance.
- What it finds
- The three kinds of evidence FDA's September 18, 2026 warning letter described: orders with no prescriber determination, determinations repeated word for word across patients, and monthly volume per formulation against the four-a-month line.
- The prescriber's signature
- The prescriber signs their own determination from a link, with a one-time code and an NPI check, typed or drawn, into your signature chain. Veritura never offers a statement to pick.
- Where it is kept
- Orders, patient references and the prescriber's words stay in your browser and a file you save. A Passport from a lot your substance screen marks essentially a copy waits until a person confirms each determination is on file.
Not checked: USP monograph acceptance criteria. Veritura reads whether a certificate claims a monograph, never whether its limits match the monograph's.
Monday, the certificates on your shelf. Friday, your first signed release.
Nothing to install, nothing for suppliers to sign up for. It starts with the paperwork you already hold.
Each certificate is filed to its lot. Record route and dose for your limits.
One standing link per supplier, no account, no cost, asking for what is missing by name.
Vera's overnight note: what arrived, what is held and why.
Signed by you, reason kept, with a Passport for each order.
He walks your records the way a surveyor would.
Questions, answered plainly.
No. It checks the paperwork and the public record, cites every finding and holds what fails. The pharmacist decides and signs. Your release policy is a preset, Strict, Standard or Lenient, plus named toggles and one threshold, never a free-form rule language. Nothing leaves a lot until a named person has reviewed it.
The notice arrives by the supplier's door, by email to your workspace's address, or typed in, and lots on file are re-matched against FDA's enforcement records every hour. Veritura names the batches made from the lot, the Passports issued from them and the clinics holding units, and opens a quality event with its reporting deadline. You declare the recall once; it reaches every clinic on Veritura holding the batch and marks each Passport. Returning units and reporting to the board stay your work.
Only through a link you create. Your record reads line by line: identity, licenses and people, accreditation and inspections, federal records and your signed statements, each checked at the source it names where one exists. A line that differs from its source says so, and never which one is right. Each link names who it is for and stops at once when you close it. No pharmacy can pay to change its record.
Partly. Veritura checks whether a USP or NF monograph exists for the substance and whether the certificate states it meets it. It does not compare the certificate's limits with the monograph's acceptance criteria. The limits it computes come from published general chapters and ICH guidelines: USP <85>, <1111>, <467> and <232>, ICH Q3C and ICH Q3D.
A PDF with a text layer, or a plain-text certificate, is read directly. Scans and photos go through a vision reader, page by page, where it is enabled. A document that cannot be read is reported as unreadable, never as clean: no check runs on it.
Nothing new. Each supplier gets one standing link from you and answers through it with no account, no login and no cost. The reply they see is facts, received, read and which requested items it satisfies, never a grade and never a document-integrity finding.
What you choose to show: supplier files with their dated elements, lot decisions with names and reasons, Cato's packet with what is missing listed first, or a read-only records room whose link stops answering when you close it.
Only a patient's email address comes to us, and only for recall notices. The server never keeps your patients or prescribers' words for the copy file; those stay in your browser and a file you save, and an order is kept only as the reference you send. When you email a patient their Passport, the address is used to send it and then kept as a recall contact for that batch, so a recall reaches that patient by email the same day. It is used for nothing else, never shared, and deleted a year after the batch's use-by date or as soon as the patient opts out. You can switch patient email off at any time.
Still have questions? Talk to a person.