A substance, a maker, a lot. Every answer dated.
What do I type?
The substance and the maker as the certificate prints them, and the lot number. The rest is optional. Do not enter a patient's name or a prescription number.
Six records, one page. Each with its source and its date.
What does the receipt read?
Only public records and the certificate you give it. Each line on the receipt names the one it came from.
| Record | What the receipt shows |
|---|---|
| The substance and section 503A | The three doors of 21 U.S.C. 353a(b)(1)(A)(i): a USP or NF monograph title in FDA's substance registry, a marketed product in Drugs@FDA, or a place on 21 CFR 216.23(a); FDA's 503A categories as printed; and 21 CFR 216.24. |
| The maker on the certificate | Its registration in FDA's establishment registry, and FDA import alerts, warning letters and recalls under its name. Warning letters and recalls count as recent only within 24 months; older ones are shown as history. |
| The 503B routes | FDA's 503B bulks list and its drug shortage list, for an outsourcing facility (21 U.S.C. 353b(a)(2)(A)). |
| The certificate | When you add it, the free read's own counts: the checks met, not met, for your call and not run. What a valid certificate carries. |
| The potency factor | Worked out from the certificate's assay and its water or loss on drying, with the arithmetic, for a person to confirm before weighing. |
| The beyond-use date limit | The ceiling USP's table gives for the preparation, and the lot's own date when it is earlier. |
Records, not a ruling. The pharmacist decides.
What does the receipt not say?
It never says to use the lot. It shows what each record says on the day it was read, and where a record was not asked or did not answer, it says so.
A name match is not identity. FDA's records are searched by the name you type. Every match says to confirm it is the same firm.
A route is one condition. A recorded route through section 503A leaves the rest of the section: a registered maker, a valid certificate for each bulk substance, and the conditions on the preparation.
Nothing is kept. No substance, maker, lot or file is stored. One row counts that a receipt was made, with none of them in it.
Veritura reads documents. It does not test material, grade a medicine or rule on what a pharmacy may compound.
FDA's 503A list, checked daily.
Every name in 21 CFR 216.23 and FDA's three categories, as printed, with each change dated and an email watch.