On November 18, 2013, HR 3204, The Drug Quality and Security Act passed both Houses of Congress. After the Senate convened on the 18th, Senator Harry Reid, (D-NV) withdrew the cloture motion on H.R.3204, Drug Quality and Security Act, and the pending motion and amendments. Then the Senate passed H.R.3204 by voice vote. Last Wednesday, President Obama signed the bill into law. Click here for release.
IACP is encouraged by the remarks made on congressional record regarding HR 3204. Senator Tom Coburn, MD (R-OK) wrote:
“Currently, the compounding and dispensing of prescription drugs for in-office administration by a prescriber to their patient is governed by state Boards of Pharmacy and states have determined what is best for their state regarding office-use. In fact, more than 40 states that have passed laws over the last 15 years related to current practices of using compounded drugs in the office context.
The issue of office-use, indeed all of pharmacy practice regulation, is best left to the States. So, the omission of office-use from 503(a) should not signal to the FDA that it has the authority to encroach upon state authority to regulate office-use.”
Senator John Boozman's (R-AR) remarks for the congressional record on HR 3204, 11.18.13, state that efforts should be made to ensure commonsense compounding, repackaging and office-use administration of compounded drugs. Both Senators Coburn and Boozman's remarks can be read in their entirety in the below noted links.
Click here to track the bill.
Click here to view the current HR 3204 pending President Obama's Signature
Click here to read Sen. John Boozman's remarks for the congressional record
Click here to read Sen. Coburn's remarks for the congressional record
Click here to view HR 3204: Full Congressional Testimonial and Colloquies (The relevant sections begin on page 36 and continue on to 41.)