Thursday, May 14, 2015

More and More State Boards of Pharmacy Acknowledging That Federal Law Now Prohibits Office Use Compounding Sold by Traditional 503A compounding pharmacies to Phyisicans for human use and that to Do so is A Violation of Federal Law Notwithstanding Any state laws to the contrary



quoted from: from http://www.deadiversion.usdoj.gov/mtgs/pharm_awareness/conf_2015/march_2015/alverson.pdf

(caveat: 30% rule is only applicable for states who end up signing MOU with FDA; In states that the MOU is not signed 5% will be the limit as provided for in federal legislation passed by Congress). Further note: comment period on 30% rule is still open as reader notes and that amount could change-5 % was provided for by Congress in statute and can only be changed by Congress not during comment period or by the FDA- slide prepared and presented by the Alabama Board of Pharmacy

4 comments:

Southparkblast said...

The MOU is not even final yet and those caps could very much change. We are in the middle of a comment period. The fact that DEA is putting this out there as current requirements is reprehensible.

bloglady said...

The five percent is in a statute passed by Congress. That amount cannot change unless Congress amends the statute. The thirty percent possibly could change and the FDA ( not the DEA )could reduce it to the five percent Congress passed into law. Links
Permalink ?
http://www.lawofcompoundingmedications.com/2015/03/fact-five-percent-limit-on-compounded.html

bloglady said...

Also note the posted slide is one prepared and presented by the Alabama Board of Pharmacy not the DEA.

bloglady said...

Here is prior post in case hyperlink about does not work:
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pulled out of thin air; Pharmacists Seem to Still be Under the Impression Based on Comments Being Made Regarding the Draft Guidance that the FDA is responsible for the five percent limit when in fact the FDA is being more generous in the draft MOU and allowing 30 percent for those states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

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).