JennaRN said:Dead space is the answer to the missing dose.
I am going to disagree with reconstituting low as a general rule. More diluent, more punctures, more in-use days at room temperature, and the stability trade-off is real. Precision is not the only variable being optimised.
I would rather be corrected than agreed with, if it comes to it.
Adding the numbers, since they settle part of this. Two things anyone can check: a state licence number for a 503A, and an FDA outsourcing-facility registration for a 503B. Both are publicly searchable, and a pharmacy unwilling to give you either has answered the question.
Ask again with the specifics and you will get a better answer than this one.
PeptideChemSF said:I am going to disagree with reconstituting low as a general rule.
There is a second half to this that has not been said yet. They are two different exemptions from the same federal requirements and they buy different things. A 503A pharmacy is regulated primarily by the state board, needs a patient-specific prescription, is exempt from CGMP, and may use a bulk substance that has a USP monograph, is a component of an approved drug, or appears on the 503A bulks list — three independent doorways. A 503B outsourcing facility registers with the FDA, is inspected on a risk basis, must comply with CGMP, may compound for office stock without a patient-specific prescription, and has one doorway to a permitted bulk substance: the 503B bulks list, or the drug shortage list.
Sigma-Aldrich — Research-Grade Standards
Certified reference materials, analytical reagents, and research-grade standards for peptide verification. Trusted by laboratories worldwide.
Shop Reference StandardsFollowing on from wendy_avl — and this may be the naive question:
How to check the arithmetic without trusting a website calculator, since three calculators gave me three answers?
OP back with an update, since a thread like this is useless without one.
Follow-up: it was dead space. Switching to a low-dead-space fixed-needle syringe gave me the tenth dose back.