FACT: The five percent limit on compounded drugs distributed out of state was a percentage passed into law by Congress (21 USC 353a) Not a Number the FDA pulled out of thin air; Pharmacists Seem to Still be Under the Impression Based on Comments Being Made Regarding the Draft Guidance that the FDA is responsible for the five percent limit when in fact the FDA is being more generous in the draft MOU and allowing 30 percent for those states that enter into the MOU: I encourage all Pharmacist, Physicians and Consumers to Read the Actual Federal Statute Rather than Taking Mine or Others Word for what it Says

(3) Drug product

A drug product may be compounded under subsection (a) only if—

(A) such drug product is not a drug product identified by the Secretary by regulation as a drug product that presents demonstrable difficulties for compounding that reasonably demonstrate an adverse effect on the safety or effectiveness of that drug product; and

(B) such drug product is compounded in a State—

(i) that has entered into a memorandum of understanding with the Secretary which addresses the distribution of inordinate amounts of compounded drug products interstate and provides for appropriate investigation by a State agency of complaints relating to compounded drug products distributed outside such State; or

(ii) that has not entered into the memorandum of understanding described in clause (i) and the licensed pharmacist, licensed pharmacy, or licensed physician distributes (or causes to be distributed) compounded drug products out of the State in which they are compounded in quantities that do not exceed 5 percent of the total prescription orders dispensed or distributed by such pharmacy or physician.

The Secretary shall, in consultation with the National Association of Boards of Pharmacy, develop a standard memorandum of understanding for use by the States in complying with subparagraph (B)(i).

21 USC 353a which can be found here (emphasis supplied in quote).