You correctly point out that distribution [to the end user] is part of the manufacturing process and not a separate process. And given that there are a number of progressively "uncontrolled" or "as-yet-unqualified" distribution nodes before a medication reaches its end user - wholesalers, secondary wholesalers, retail or specialty pharmacy "outlets", common carriers - the manufacturer need to supply these outlets with basic information on storage and shipping parameters. This information would be considered "off-label"; but it is necessary. For example, where in the manufacturing QA/QI process can I discover if Copaxone which has label storage and shipping rquirements of 2-8C can be shipped over 48 hours at 1-10C for "home delivery" in a pre-qualified shipping container? Unless this type of information is available from the pharmaceutical manufacturers, the preservation of "proper" medication storage will remain a desideratum.