International compounding regulations — 6 month update

Taking the question as asked, rather than the general version of it. 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.

BethLabQueen said:

They are two different exemptions from the same federal requirements and they buy different things.

Agreed, and the enforcement dates were staggered by category — 503A first, 503B a few weeks later — because outsourcing facilities have manufactured inventory and clinic contracts to unwind while a 503A makes to order.

Admin said:

Living somewhere the domestic route does not exist, which makes most of the advice on this board inapplicable to me.

This matches mine closely enough to be worth saying so. 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.

From the other side of the consultation, briefly.

My experience ordering cross-border ordering internationally: I've ordered from a Canadian pharmacy. Customs can be hit or miss.

Shipping time: 10-21 days
Customs clearance: held for 3 days then released
Quality: Janoshik tested at 97.3% purity

International ordering adds complexity but can save 60-80% compared to US prices. Research your country's import laws first.