IACP Members: Your Comments are Needed!
FDA Reopens Docket on Compounding Documents
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 So, while IACP and compounders can submit comments on the draft guidance documents that are directly related to repackaging, adverse event reporting, and the Memorandum of Understanding there has been no place where physicians,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.
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IACP Summary on FDA Four Draft Guidance Documents and MOU
Please click here to view.
Watch for additional information through IACP’s Capitol Connections newsletter, our email and FAX Member Alerts, our social media postings via Twitter and FaceBook. Be sure to continue visiting the Breaking News section of our website.
Drug Product Compounding Issues Addressed by FDA Panel
On February 23, 2015, FDA's Pharmacy Compounding Advisory Committee voted to add 25 drugs to the list of drug products that may not be compounded under the exemptions provided by the Federal Food, Drug, and Cosmetic Act because, "they have been withdrawn or removed from the market as a result of their components having been determined to be unsafe or ineffective."
Please click here to read more.
IACP Sets the Record Straight with USA Today and Pharmacy Times
IACP take its mission of Protecting, Promoting & Advancing Pharmacy Compounding very seriously. In addition to our ongoing efforts of generating proactive compounding stories in the press, we also will take the time to correct erroneous information whenever we see it!
Please see two recent news stories in USA Today, and Pharmacy Times, that screamed for a response. IACP Members: We encourage you to provide IACP's responses to the respective publications to your patients and physicians who may be have questions or who are confused by these articles.
Media Stories and IACP Responses
Please click here to read the USA Today story.
Please click here to read IACP's response.
Please click here to read the Pharmacy Times story.
Please click here to read IACP's response.
Have you seen an article that needs IACP's response? Please email IACP's VP of Communications Dagmar Anderson at firstname.lastname@example.org.
Did You Miss IACP's Town Hall on FDA's Guidance Documents and MOU? Recording is Available!
At last month's Town Hall, IACP Leadership reviewed FDA’s Four Guidance Documents and MOU draft released on Feb. 13th, answering member questions, and detailing next steps.
IACP has received many, many questions regarding these proposed guidelines. We recorded the Town Hall and encourage you to listen at your convenience.
Recording Available: The Town Hall Recording has been uploaded to the Members-only Site. Please click on the Member Resources icon, then select,
Town Hall Teleconference Recording to access all Town Hall Recordings.
Click here to access this Town Hall Recording - you will need to be logged in to view.
New State Legislation Tracker on Pharmacy Provider Status
IACP Members: Check out the brand-new feature on our Compounders Stateside page. We've added a new State Legislation Tracker on Pharmacy Provider Status. Click here to view!
Announcing the Spring 2015 Student Writing Competition!
The Theme: "Should States Institute a 'Wet Lab' Examination as Part of the Pharmacist Licensing Process?"
The IACP Foundation created its semi-annual Student Writing Competition to recognize outstanding original papers on a particular topic affecting pharmacy compounding. THREE winners will be selected by a review committee from the papers submitted. The winners of this writing competition will each receive a $500 cash prize. All pharmacy students are encouraged to compete.
Entries are due by Monday, April 20, 2015! Click here for more information. Please email IACP Foundation's Jennifer Petska with any questions!
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.
USP Announces Revised Chapter of the Proposed <800> Available for Viewing
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.