IACP Legislative Updates
Arizona Congressman Matt Salmon Meets with Potter's House Apothecary
Potter's House Apothecary in Peoria, Ariz., welcomes Congressman Matt Salmon (R-AZ) to their pharmacy for a tour on Tuesday, August 27th, to discuss quality standards employed in their compounding pharmacy practice, and the current legislative draft S. 959. Pictured left to right are Potter's House Apothecary's Amber Swaney, Jeremy Lundevall, CPhT, Cong. Salmon, and IACP Board Member Kevin Borg, PharmD, FIACP.
Thank you to the many IACP members who have invited their representatives to their pharmacies during the congressional break! They are helping to emphasize the necessity of compounding for patients and practitioners, and to explain the issues that need to be resolved with the current S. 959 draft. Check out next week's IACP Capitol Connections member newsletter for more on these congressional visits.
IACP Works with Congressman Griffith and House E&C on New Compounding Draft
IACP has been meeting with members of the House Energy & Commerce Committee, and specifically Congressman Morgan Griffith (R-VA) regarding a pharmacy compounding draft being developed in the House. IACP will keep our Members informed of updates on this draft.
Click here for an article from Roanoke Times quoting Congressman Griffith on the effort.
Congress at Home, DC Still Works
Even though recess has started, staff continues to plug away at compounding legislation on both the Senate and House side. This week IACP met with offices on both side to discuss the many changes needed to S. 959 in its current version and emphasize why changes and amendments have to occur in order to preserve traditional compounding and the states’ authority for regulating that practice.
We do know that both the Senate HELP and House Energy & Commerce Committee staff are talking about the content and components of S. 959 and how they either align or conflict with the draft bill under development by Congressman Griffith. At the present time, the House is more inclined to limit changes to 503(a) to clarifications rather than the substantial and detailed rewrite included in the Senate.
The IACP 2013 Summer CAMP (Congressman at My Pharmacy) Packet Now Available!
The IACP 2013 Summer CAMP (Congressman at My Pharmacy) packet is now available in the Members-only site - click on Member Resources.
Your IACP CAMP packet includes everything you need to prepare and host a successful congressional visit at your pharmacy. It includes:
- Instructions for setting up a pharmacy tour with a member of Congress
- Sample invitation FAX/e-mail to the Senator or Representative's scheduler
- Sample schedule for the legislator and a sample schedule for your pharmacy team
- Talking points on pending federal legislation with background explanations to educate yourself and your staff
- "Day Before" and "Day Of" event instructions
- A sample thank you letter for follow-up
- Information on inviting a local media outlet to showcase your visit (pending approval by the legislator)
- Evaluation form to share your experience with IACP
Go to IACP's Members-only site to access your CAMP packet. Please email IACP at firstname.lastname@example.org with questions!
Revision to S. 959 Secured by IACP: Expressly permits anticipatory compounding for office use
As a result of our continued discussions with the Senate HELP Committee, IACP has succeeded in securing language which clarifies that anticipatory compounding will be permitted within S. 959 as part of the bill’s overall revision of Section 503A of the Federal Drug and Cosmetic Act (FFDCA).
As Section 503A (a)(2)(A) reads now, compounds drug can only be prepared "by a licensed pharmacist or licensed physician in limited quantities before the receipt of a valid prescription order for such individual patient." Although never enforced, that language does essentially prohibit anticipatory compounding for preparations that are subsequently dispensed or sold to health practitioners for office-use.
Although earlier versions of S. 959 had different language for anticipatory compounding – one of which made it even more stringent and associated with an individual patient – IACP and the Senate HELP Committee have found common ground with new wording. While S. 959 retains most of the original language of 503A, it now includes an entirely new provision that would - for the very first time - acknowledge and permit anticipatory compounding for office use. Specifically, with respect to a "traditional compounder," the bill provides that "in lieu of the prescription for an identified individual patient... the pharmacy receives a practitioner order." [Page 16, lines 1 - 5].
While that’s a “win” for compounders, there are still so many unworkable provisions within S. 959 that push the scope of federal authority over traditional pharmacy compounding practice well beyond that necessary to prevent a future NECC tragedy. For example, new requirements for office-use prescriptions mean burdensome recordkeeping provisions for pharmacies including a 10% monthly limit, a 14 day “window” in which the pharmacist must obtain the names of specific patients to whom the medication was administered by the ordering office or practitioner, and a 14-day cap on beyond use dating.
- Your IACP legislative team in D.C., has learned that beginning on Monday, August 5th, members of the House Energy & Commerce and Senate Health, Education, Labor & Pensions (HELP) committees are going to meet daily throughout August to try and begin negotiating a consensus bill on drug compounding. IACP will keep you apprised. Please check back to IACP's S. 959 Updates for the latest information from our legislative team working on your behalf.
Save the Date for IACP Member Town Hall, July 7th
IACP Members: Save the Date for an IACP Town Hall on Wednesday, August 7, 2013, 2 pm EST - 1 pm CST - 12:00 pm MST - 11:00 am PST.
We're about to go to Congressional Recess. IACP's David Miller and Sarah Dodge will provide an S. 959 update, ideas on what you can do during the next three weeks to ensure a positive S. 959 outcome, as well as share how the IACP Camp (Congressman at my Pharmacy) program can help you get the word out to your representatives home for recess.
Look for the blast fax we sent to all members, or visit our Members-only site for call-in details!
My Health. My Compounds. Tell Washington what you think of S. 959!
My Health. My Compounds. Tell Washington what you think of S. 959! Click here to learn more about S. 959, how it could impact patients, and take action on IACP's advocacy site. Please share this site with your patients and practitioners so that they can take action on behalf of pharmacy compounding.
Click here to access IACP's My Health. My Compounds artwork - please feel free to feature on your websites, social networking pages.
- IACP is meeting today at 2:30 pm Eastern with the U.S. Senate Committee on Health, Education, Labor & Pensions (HELP) to review and comment on the latest version of the pharmacy compounding draft bill S. 959.
- Are you continuing to receive emails and social networking notices that there is a Senate vote on S. 959 occurring this week? Please note that this information is incorrect. There is no S. 959 vote scheduled or likely this week.
- IACP Members: Join us for a Town Hall on Wednesday, August 7th at 2 pm Eastern, 1 pm Central, 12 pm Mountain, 11 am Pacific. IACP will provide you with the latest update on S. 959, as well as action steps on what you can do during the congressional August recess to ensure a positive outcome regarding S. 959. A Blast Fax will be sent to you soon with call-in information.
Please email email@example.com if you have any questions on this information. IACP is working to Protect, Promote & Advance Pharmacy Compounding!
IACP Message Points: Why the Current Draft of S. 959 is Still Unworkable
Should you have media and others reach out to you about the current draft of S. 959 – see below for IACP message points for your use. Please email firstname.lastname@example.org if you have any questions on this information.
- The compounding community has been collaborating with lawmakers and their staff on the development of legislation that will ensure we never have another NECC.
- The bill that has emerged from the Senate HELP Committee, Senate 959, will not protect patient safety and therefore IACP and the compounding community is not supporting it at this time.
- The bill exempts hospitals, health systems, and pharmacy benefit managers from the very protections it is putting in place, and we believe that these large exemptions will create safety gaps. We believe that every patient should be assured of the same level of safety, whether they get their compounded medications from a pharmacy, a hospital, or a mail order pharmacy.
- The bill also could interfere with patient access to compounded medications. For instance, it prohibits the re-packaging of certain medications even when those re-packaged medications are far less costly. It creates restrictions on anticipatory compounding and office use, two methods for patients receiving medications when they need them.