COMP PAC to Host Congressman Morgan Griffith at April 28th Reception
On April 28th, following an IACP-led Fix DQSA Stakeholder meeting, Congressman Morgan Griffith (R-VA) will be the special guest at a COMP PAC reception.
"Congressman Griffith has been an ongoing supporter of pharmacy compounding, says COMP PAC Chair Michael Blaire, RPh, as well as a proponent of ensuring that the Drug Quality & Security Act (DQSA) is enacted as intended by Congress, specifically in regards to patient access and compounding for office use.
Please join me in contributing to this cause."
Please click here to RSVP and/or to contribute.
California Board of Pharmacy Withdraws Sterile Compounding Regulations
On April 21, 2015, the California Board of Pharmacy (BOP) voted to withdraw its proposed regulations related to sterile compounding.
The BOP took this action after receiving numerous written comments from the California Pharmacists Association (CPhA) and other stakeholders on the proposed regulations and regulation-setting process.
The BOP will use the most recently revised version of the proposed regulations as a starting point for a new rulemaking package, which the BOP will release in the coming months.
As the BOP moves forward with new proposed regulations, CPhA says it will continue to advocate for regulations that are consistent with USP Chapter <797> and establish meaningful requirements to allow pharmacists to safely produce sterile compounded preparations.
Bill Introduced Last Week in Massachusetts Legislature Would Permit Office Compounding in the State
Bill S.1173 189th (Current), introduced last week in the Massachusetts legislature, is an Act to authorize the dispensing of compounded prescriptions for office and institutional settings without patient- specific prescription.
Please click here to read more.
FY2016 Small Business Reduction for Outsourcing Facility Fee: Deadline for Requests is April 30th
Facilities that elect to register with FDA as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) must pay an annual establishment fee.
The annual establishment fee is paid at the time of registration and is equal to the sum of $15,000, multiplied by the inflation adjustment factor, plus the small business adjustment factor for the fiscal year in which the fee is due.
The deadline for requesting a small business reduction for the FY2016 outsourcing facility annual establishment fee is April 30, 2015. If you do not request the reduction by that date, you will not qualify for the fee reduction.
Click here for more information.
IACP Leadership Participating in FDA's April 30th Compounding Stakeholder Meeting
The Food & Drug Administration (FDA) has invited IACP to participate in a Pharmacy Compounding stakeholder meeting on April 30, 2015 at the White Oak Campus in Silver Spring, Md.
In their invitation, FDA states, "As you may recall, we held a series of listening sessions with groups of interested stakeholders last year to discuss FDA’s efforts to implement the compounding provisions of the Drug Quality and Security Act, signed into law in November, 2013.
We met with pharmacy and industry organizations, medical organizations, consumer groups, hospital organizations, insurers, animal drug organizations, and radiopharmaceutical organizations."
The FDA says it will hold at least six sessions this year: pharmacy and industry organizations; medical organizations; consumer and patient advocacy groups; hospital organizations and insurers; outsourcing facilities registered under section 503B; and radiopharmaceutical organizations."
Please note: The FDA will not be webcasting the sessions. Each organization will be provided the opportunity to make a statement of five minutes or less, depending upon how many people will be participating in each session.
IACP will provide an update in an upcoming Capitol Connections member newsletter.
Please click here to view information about FDA meetings at the White Oak Campus. IACP will provide updates regarding this meeting in an upcoming newsletter.
IACP Provides You with the Latest State Updates!
IACP Members: Check out the latest state news on IACP's Compounders Stateside page. We've also added a new State Legislation Tracker on Pharmacy Provider Status. Click here to view!
Click here for a comprehensive document with up-to-date compounding activity in your state. IACP is tracking 48 state bills. Four bills were introduced last week.
2015 State Board of Pharmacy Meeting Schedule - please click here to view.
IACP Members: Have You Used the New Compounding Fact Sheet, Yet?
To help our members address questions from their patients, practitioners, media and others in their community, IACP has prepared a new Compounding Fact Sheet for your use.
It includes a compounding profession overview, message points in response to the NECC tragedy, current oversight info, and IACP concerns regarding DQSA.
Please click here to access.
Comment Period Ends on May 31st for USP's Revised Chapter of the Proposed <800>
The United States Pharmacopeial Convention (USP) announces that the revised chapter of the proposed <800> is now posted on the USP website. Please click here to review.
The chapter will still be proposed in the Pharmacopeial Forum 41(2) in Mar/April 2015. The comment period for this chapter will end on May 31st, 2015.