By Kevin Schweers
Three days before today’s government shutdown produced by partisan gridlock, Republicans and Democrats came together to approve drug safety legislation and re-affirm their support for compounding services provided by independent community pharmacies.
On a voice vote, the House of Representatives approved H.R. 3204, The Drug Quality and Security Act, legislation endorsed by NCPA, that responds to the tragic 2012 meningitis outbreak and adopts supply chain protections. The legislation is currently awaiting approval by the Senate. In the debate preceding the vote, lawmakers discussed how the bill protects community pharmacies’ ability to continue to compound drugs for their patients and asserted their intent to monitor its implementation to ensure it does not inadvertently infringe upon long-accepted compounding pharmacy practices.
“Mr. Speaker, this bill upholds the current section 503(a) of the law, and provides it with the clarity that FDA needs by eliminating the unconstitutional provisions,” said House Energy and Commerce Committee Chair Fred Upton (R-Mich.). “The bill also requires FDA to engage in meaningful communication with State boards of pharmacy. Further, under this bill, entities engaged in sterile drug compounding can voluntarily register with FDA and operate under FDA regulation. Finally and importantly, this bill protects traditional pharmacy compounding that occurs in community pharmacies across the country. That’s why the bill has the support of the National Community Pharmacists Association, and I would like to thank them for working with us so closely.”
Health Subcommittee Chair Joe Pitts (R-Penn.) opened his remarks noting that, “First, the bill would protect traditional pharmacies and clarify laws related to human drug compounding in response to last year’s nationwide meningitis outbreak – one of the largest public health crises in recent memory.” He also cited NCPA as one of the bill’s supporters, among other industry groups.
From the Democratic side of the aisle, Health Subcommittee Ranking Member Frank Pallone (D-N.J.) added that, “The bill will permit compounders who wish to practice outside the scope of traditional pharmacy to register as outsourcing facilities, but those who choose to remain traditional pharmacies will continue to be regulated as they are under current law.”
After discussing other provisions of H.R. 3204, Rep. Diana DeGette (D-Colo.) noted, “Importantly, all other compounding pharmacies would continue to be subject to current law.”
Turning to next steps and implementation of H.R. 3204, several lawmakers spoke up regarding their intent for the bill and how it should preserve well-established compounding pharmacy practices.
“My test for consideration of new categories of regulation is that it must not impact the traditional practice of medicine, pharmacy, or compounding,” said Rep. Michael Burgess (R-Texas), a physician. “Mr. Speaker, no bill is perfect. There’s always the risk of unintended consequences. I sincerely hope that this language will pass this test; but if it does not, I hope that our committee and this body will stand ready to do the necessary oversight and correct any unintended consequences.”
Rep. Gene Green (D-Texas) added, “I hope that the FDA uses their enforcement discretion to maintain patient access to important drugs from nuclear pharmacies, certain repackaged drugs, and drugs for ‘office use.’”
The point was further underscored by Rep. Pete Sessions (R-Texas), who noted, “Mr. Speaker, I will continue to monitor the implementation of Section 503(A) in consultation with compounding pharmacies in Texas, and call on the FDA to ensure that these provisions are not used to restrict interstate sales of compounded pharmaceuticals within all applicable laws and regulations.”
NCPA members can read more details about the legislation in the Sept. 27 Executive Update email from CEO B. Douglas Hoey, RPh, MBA.