406 Attendees Convene in Washington, D.C. for the 21st Annual Compounders on Capitol Hill
The United Voice of Compounders Is Heard!
A special thanks to all the IACP members who participated either in person at Compounders on Capitol Hill, held, June 6-9, 2015 at the Renaissance Washington DC Downtown Hotel, or via our Virtual Hill Day -- your efforts made a HUGE impact. And a fast one as well. One of our key messages to Senators and Congressmen was that the U.S. Food and Drug Administration (FDA's) interpretation of the Drug Quality & Security Act (DQSA) appears to ignore Congressional intent. Despite repeated invitations from IACP to speak with our CCH conference attendees, everyone at the FDA was again "unavailable" this year to attend and talk to those most impacted by the agency's activities... and that was noticed by Congress.
“Compounding pharmacists went to Washington to speak with their Senator and Congressional representatives about several issues that directly affect their patients,” says IACP President Dale Coker, RPh, FIACP. “We were particularly interested in discussing the Drug Quality and Security Act (DQSA) with our respective representation to ensure access to pharmacy compounding continues. We also emphasized the need for increased communications between the States and FDA as this legislation continues to go into effect.”
Please click here to view more, including the 2015 CCH Asks, Senator Vitter's SB 1406, Hill Day Stats and the CCH 2015 Photo Gallery!
Senator Vitter Introduces Legislation: SB 1406
IACP is pleased to announce that U.S. Senator David Vitter (R-La.) has introduced legislation to protect and expand access to life-saving compounded medications. The IACP-led DQSA coalition has worked diligently with the Senator's office to ensure that patient access to compounded medications continues.
From Senator Vitter's press release - "Compounded medications are used to treat patients with unique medical conditions that make them resistant to standard medications, such as pediatric cancer patients. Vitter’s legislation, the Saving Access to Compounded Medications for Special Needs Patients Act, would ensure that patients have access to the custom medications they need"
“Compounded medications often go to the most vulnerable patients, like cancer patients and children with special needs. Our children’s health and safety need to be our very top priority, and Louisiana families shouldn’t have to drive to Texas to get life-saving medications,” Vitter said. “FDA overreach is jeopardizing access to these medications, and my legislation would make sure patients and families can get the medicines they need as quickly as possible.”
Please click here to read more.
FDA Extends Deadline for Comments on MOU
The Food and Drug Administration (FDA) is extending the comment period in the notice of availability that originally appeared in the Federal Register of February 19, 2015 until July 20, 2015. The Agency is extending the comment period both for the draft standard Memorandum of Understanding (MOU) and for information collection issues under the PRA for 30 days, until July 20, 2015. The Agency believes that a 30-day extension allows adequate time for interested persons to submit comments without significantly delaying resolution of these important issues.
Please click here for additional information.
The U.S. Food & Drug Administration (FDA) has established a public docket to receive information, recommendations, and comments on matters related to the Agency’s regulation of compounding of human drug products under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
This docket is intended for general comments related to human drug compounding that are not specific to documents or issues that are the subject of other dockets. So, while IACP and compounders can submit comments on the draft guidance documents that are directly related to repackaging, adverse event reporting, and the Memorandum of Understanding there has been no place where physicians, patients, pharmacists and others can voice our concerns about office-use.
If office-use is important to your practice or your prescriber clientele, this public docket is the perfect place to file your comments about how the FDA is ignoring Congressional intent and disregarding state laws and regulations permitting office-use.
Last week, IACP filed comments on the FDA Guidance Document with the Agency. Please click the below links to view IACP's comments.
FDA's "Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities"
"Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act"
"Repackaging of Biologics"
Letter from Congress
Click here to view a Congressional letter regarding the repackaging of biologics.
FDA Public Docket
IACP Members! Click here to access the FDA Public Docket, which includes comment submission instructions.
Make your voice heard! Let the FDA know of your concerns on the recent compounding implementation plan.
IACP Summary on FDA Four Draft Guidance Document
Please click here to view.
IACP Participates in FDA's PCAC Meetings This Week
IACP representatives David Miller, CEO/EVP and Cynthia Blankenship, VP Government Affairs, participated this week in the FDA's Pharmacy Compounding Advisory Committee meeting held in White Oak, Maryland.
The PCAC voted to add four additional drugs to the "do not compound" list that have been withdrawn or removed from the market for safety concerns or lack of efficacy. They are:
Acetaminophen: all drug products containing more than 325mg of acetainophen per dosage unit
Aprotinin: all drug products containing aprotinin
Ondansetron HCl: all IV drug products containing greater than a 16mg, single dose of odansetron
Bromocriptine Mesylate: all drug products containing bromocriptine mesylate for prevention of physiological lactation
These four will be in addition to the 26 medications voted on by the PCAC at their first meeting in February 2015. Although the Committee has voted to add these medications to the existing list, that will not become formal until accepted by the Secretary of Health and Human Services and published in the Federal Register. IACP will alert its members when the updated list goes into effect.
PCAC also considered four Active Pharmaceutical Ingredients (APIs) which do not have a USP/NF monograph or are not a component of a current or previously approved FDA manufactured drug product. Under 503A, compounding using bulk ingredients that lack monograph or approval status is permitted once the FDA and the Secretary of Health and Human Services consider submitted drugs and those are reviewed and decided upon by the FDA PCAC. The Committee did not consider any bulk ingredients for 503B outsourcing facilities; their decision today is only for traditional compounders.
Please click here to read more.