Wednesday, August 2, 2017

Proposal Would Loosen Compounding Regulation

By Walter F. Roche Jr.

Fifteen days after filing a bill to loosen federal regulation of drug compounders, a Virginia congressman got $5,000 in contributions from the political action committee formed by drug compounders.
Records at the Federal Election Commission show the $5,000 was donated to the campaign fund of H. Morgan Griffith, a Virginia Republican, on June 27. It wasn't the first contribution by the political action committee for the International Association of Compounding Pharmacists to Morgan. He also got  $5,000 in the previous election cycle.
On June 12, the day the bill was filed the IACP issued a press release praising Morgan and U.S. Rep. Henry Cuellar, a Texas Democrat, for filing the bill entitled "Preserving Patient Access to Compounded Medications.
Charging that the U.S. Food and Drug Administration has been misinterpreting a new law, the Drug Quality and Security Act, passed in 2013, the IACP says the FDA is asserting "regulatory authority over the practice of pharmacy and medicine in a way Congress never intended."
As a result, the IACP says, patients are being deprived of easy access to drugs compounded by local pharmacists.
That new statute was passed in the wake of a deadly fungal meningitis outbreak that sickened 758 patients killing 76 of them. Many of the victims resided in Griffith's district which includes parts of Roanoke County
Dr. Richard Carome of Public Citizen already is warning that passage of the Morgan/Cuellar proposal will likely lead to a repeat of the 2012 outbreak.
That outbreak was caused by a Massachusetts drug compounding firm, the New England Compounding Center in Framingham, Mass.
Next week the former president of NECC is scheduled to begin serving a nine year prison sentence  following his March conviction on racketeering, conspiracy and mail fraud charges.
Carome has charged that the main effect of the IACP proposal is to eliminate a requirement that there be a patient specific prescription before a drug can be compounded by a state licensed pharmacist.
Under the 2013 law congress created a new category of drug producers who can compound drugs without patient specific prescriptions but they must first register with the FDA and meet certain requirements.
Morgan 's proposal would create a loophole negating the effect of that requirement, Carome has charged.
The IACP, which holds an annual fundraiser in Washington, DC, has regularly supported congressional candidates backing their positions. FEC records show the IACP PAC raised $48,825 between Jan. 1 and June 30 of this year.

IACP Applauds the Leadership of Congressmen Griffith and Cuellar in Introducing Bill HR 2871

Wednesday, June 14, 2017   (0 Comments)
Posted by: Dagmar Anderson
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IACP Applauds the Leadership of Congressmen Griffith and Cuellar in Introducing Bill HR 2871
The “Preserving Patient Access to Compounded Medications Act of 2017†is a bipartisan effort to preserve patient access to vital compounded medications.

WASHINGTON – June 13, 2017 - The International Academy of Compounding Pharmacists (IACP) strongly supports new legislation, introduced by U.S. Congressmen Morgan Griffith (VA) and Henry Cuellar (TX), HR 2871 – The Preserving Patient Access to Compounded Medications Act of 2017, formally introduced on June 12, 2017. More than 300 compounding pharmacists traveled to Washington, D.C. on behalf of their patients and physicians to meet with their respective congressional representatives to discuss the Bill’s content, and to urge them to co-sponsor HR 2871.
IACP President Baylor Rice, RPh, FIACP, says, “On behalf of the International Academy of Compounding Pharmacists and the patients we serve, thank you, Congressman Griffith and Congressman Cuellar, for your leadership in introducing the bipartisan legislation, HR 2871 - The Preserving Patient Access to Compounded Medications Act.

This important bill will help protect access to medications physicians rely upon for their patients. It will help clarify the Drug Quality & Security Act (DQSA) in a way that will better align the statute with congressional intent and better balance public safety and patient access. We applaud your dedication on behalf of patients, physicians, pharmacists, and other healthcare providers who are united in a mission to preserve patient safety and access to needed compounded medications pursuant to state and federal laws and regulations.â€
IACP consistently has said that maintaining access to potentially life-saving compounded medications is not only vital for patients; but, is consistent with the legislative intent of the DQSA. While reinforcing Section 503A of the Food, Drug and Cosmetic Act (FDCA) through the passage of the DQSA, Congress came together in a bipartisan and bicameral fashion to make clear that pharmacists’ ability to provide compounded medications for a physician’s administration to or treatment of a patient within their practice should be left to the States.

IACP, working with the DQSA Coalition, has worked with the FDA and Congress on improving the agency’s compounding policies in a way that better balances public safety with patient access to critical medications. Unfortunately, despite these efforts, FDA continues to misinterpret the DQSA and assert regulatory authority over the practice of pharmacy and medicine in a way Congress never intended.  Congress has, in the last two appropriations bills  (FY16 and FY17), included report language directing the FDA to alter their policies on compounding to align with congressional intent and the language of the statute.  FDA has, to date, ignored those congressional directives and continues to substitute their desired regulatory authority over compounding.

As such, it’s vital that Congress support HR 2871 in order to preserve patient access to compounded medications by directing FDA to act within Congressional intent.

About IACP

The International Academy of Compounding Pharmacists (IACP) is an association representing more than 4,000 pharmacists, technicians, students, and members of the compounding community who focus upon the specialty practice of pharmacy compounding. Compounding pharmacists work directly with prescribers including physicians, nurse practitioners and veterinarians to create customized medication solutions for patients and animals whose healthcare needs cannot be met by manufactured medications. IACP's mission of protecting, promoting and advancing personalized medication solutions is critical for patient healthcare.  Visit to learn more and to find a compounding pharmacist near you.




  1. Oh my god! I wish that I had never read this article. Compounders need more regulation not less. God help any patient that would have to go through what myself and my family have been through and continue struggle because of a compound pharmacy running amok! Why Mr. Congressman?

  2. What the heck, why change, why do anything ? Never applied old standard, why bother making new ones ? Ask the families of the over 7xx people who spend huge amounts of time in hospital, were ruined finically, and most importantly, the deseased.
    Our elected pals watching out for your well being, rather than police themselves, just write something down and call it great. Slap yourself in the back. Call it progress, or ?