Compounded tirz stability at room temperature — 14-day data

kate.chem said:

Freezing is the one to avoid, and freeze-thaw more so.

No disagreement with kate.chem. One condition attached. Worth adding the genuine exception, because it is real and narrow: a change made for an identified patient where the prescriber determines it produces a significant clinical difference for that patient. A grid of fixed doses offered to everybody is not that, whatever the intake form says.

kate.chem said:

Freezing is the one to avoid, and freeze-thaw more so.

I read this differently from kate.chem, on substance rather than tone. The distinction that matters is unopened versus in use. Unopened vials are stable refrigerated for their labelled shelf life and tolerate a limited excursion to room temperature. Once reconstituted, the clock is much shorter and is set by the preservative rather than by the peptide — bacteriostatic water's benzyl alcohol is what buys you multiple draws over weeks. Sterile water has no preservative and turns a multi-dose vial into a single-use one.

Short answer first, then the reasoning. 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.

Dr.MetabolicMD said:

Worth adding the genuine exception, because it is real and narrow: a change made for an identified patient where the prescriber determines it produces…

Can confirm. Same sequence, different timescale. The detail I would add is minor and it is already implied above.