ingrid_STO said:

Storage question about storage and cold: my pen was left out of the fridge for 12 hours.

Same pattern here, and in the same order.

Clinical perspective, offered as context rather than as advice.

Storage best practices for compounded storage and cold:

• Unreconstituted lyophilized powder: refrigerate (36-46°F), good for 12+ months
• Reconstituted vials: refrigerate, use within 28 days
• Pre-filled pens: refrigerate until first use, then room temp OK for 28 days
• Never freeze reconstituted peptides — ice crystals damage the protein
• Protect from light — store in original box or wrap in foil

When in doubt, refrigerate. Temperature abuse is the #1 cause of reduced potency in compounded peptides.

hans_munich said:

Storage best practices for compounded storage and cold: Unreconstituted lyophilized powder: refrigerate (36-46°F), good for 12+ months Reconstituted…

Second this. I had assumed I was the exception until I read this.

hans_munich said:

Storage best practices for compounded storage and cold: Unreconstituted lyophilized powder: refrigerate (36-46°F), good for 12+ months Reconstituted…

Coming at hans_munich’s question from a different direction. 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.

Moderator note: the sourcing question belongs in the vendor section and has been split out. Thread quality here is what the rules are for. Keep it up.