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Capitol Connections July 11, 2014
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July 11, 2014 

FDA Outlines Expectations for Human Drug Compounders, Including Registered Outsourcing Facilities

FDA has issued several policy documents regarding compounded drug products for human use, as part of the agency’s "continuing effort to implement the compounding provisions of the Drug Quality and Security Act (DQSA), enacted in November 2013." The policy documents consist of a draft interim guidance, a proposed rule, a final guidance, and two revised requests for nominations for the bulk drug substances lists.

“Providing clarity to the compounding industry on the agency’s expectations for these unapproved drug products is a priority for the agency,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “These actions are essential next steps in providing the compounding industry with the appropriate tools to comply with the law and advancing the FDA’s efforts to continue protecting patients.”

For more information, click here.

Organized Pharmacy Sends Letter to USP on Proposed General Chapter <800>

IACP and several other pharmacy associations sent a joint letter to the United States Pharmacopeia (USP) regarding the proposed General Chapter <800> Hazardous Drugs - Handling in Healthcare Settings. "We respectfully request that the chapter be numbered above <1000> in order to be classified as a general information chapter, imparting best practices. Although there are many best practices included in the proposed chapter, the impact on our members and their patients is too great at this time and compliance would be extremely difficult if not insurmountable to the vast majority of pharmacies and pharmacists." Click here to read the entire letter.

House Letters Sent to FDA

 

Thank you to all IACP Members who participated in the Academy's Action Alert to obtain signatures for both Congressman Bilrakis and Congressmen Griffith, Green and DeGette's respective House letters. Holding FDA accountable for correct and appropriate implementation of the DQSA is IACP’s number one priority. FInal signatures were gathered for both of these letters and, they have been sent to the Food & Drug Administration (FDA). IACP will keep you apprised of any updates. 

Click here to view the final Congressmen Griffith, Green & DeGette letter with signatures. 

Click here to view the final Congressman Bilirakis letter with signatures.

Background:

As part of this year’s Compounders on Capitol Hill, attendees visited House offices asking for support of a letter from Congressman Bilirakis (R-FL) to the Food and Drug Administration (FDA) that raised questions about the agency’s interpretation and implementation of the Drug Quality & Security Act. In addition to concerns about how the FDA views office-use dispensing in those states that permit it, repackaging of medications, the impact on patient access, and the promotion of 503B outsourcing facilities before the agency has completed the promulgation of regulations, Congressman Bilirakis and others signing onto the letter are specifically querying why the FDA appears to be ignoring specific Congressional intent. More and more House members are signing onto the letter and IACP expects it to be forwarded on to the FDA by the end of June. To see a copy of the Bilirakis letter, please click here. To view the IACP “Ask” document explaining it, click here.

A second letter from Congressmen Griffith (R-VA), Green (D-TX), and DeGette (D-CO) raising many of the same issues also was released. IACP worked with Congressman Griffith’s staff to advise House offices of the importance of signing on to this letter as well given that these leaders on the House Energy and Commerce Committee were directly involved in the 2013 hearings in which the FDA claimed that they did not have sufficient authority to take action against the New England Compounding Center even when the agency was aware of significant deficiencies and violations dating back to as early as 2005. Congressman Griffith had introduced HR 3089 in the summer of 2013 to clearly delineate the role and responsibility of the FDA in overseeing compounding without impinging on the authority of state Boards of Pharmacy. 
   

DEA Publishes Final Rules Rescheduling Tramadol to Schedule IV

Effective August 18, 2014

The US Drug Enforcement Administration has published its Final Rule in the Federal Register placing tramadol into Schedule IV effective August 18, 2014.
 

A number of states in the country including Arkansas, Mississippi and New York have already placed tramadol as a controlled substance.
 
Acknowledging that changes such as these take time to implement, the DEA extended the usual effective date for this type of change from 30 to 45 days to provide what it considers to be "reasonable time for registrants to comply with handling requirements for a schedule IV" drug, such as moving tramadol products into a warehouse cage or adjusting suspicious monitoring systems to include tramadol orders.
 
Effective August 18, 2014 all manufacturers will be required to print the designation "C-IV" on every bottle and it is unlawful for commercial containers of tramadol to be distributed without that designation. In addition, all DEA registrants will be required to take an inventory of all tramadol stock in compliance with 21 C.F.R. §  1304.11(d).

FDA Proposes New Division, Office of Pharmaceutical Quality (OPQ)

The Food and Drug Administration (FDA) is ramping up preparations for a proposed a new division, the Office of Pharmaceutical Quality (OPQ), within its Center for Drug Evaluation and Research (CDER). The new office would exercise authority over the pharmaceutical manufacturing process throughout a product’s entire life cycle, taking over and consolidating some responsibilities from the existing Office of Manufacturing and Product Quality and the Office of Pharmaceutical Science. The FDA says OPQ is intended to become a “global benchmark for regulation of pharmaceutical quality,” that will oversee the full spectrum of medicines, including brand-name, generic, and over-the-counter drugs.
The FDA’s perceived need to establish the office underscores both the importance of pharmaceutical manufacturing processes and the concern over the recent surge in quality-control problems throughout the industry. Drug shortages have emerged as a growing problem in recent years, for example, and an FDA industry survey revealed that the single largest factor causing the shortages was a manufacturing quality issue. The agency lists “Safety and Quality” as one of its five strategic priorities for the next four years.

At a panel during the Biotechnology Industry Organization’s annual convention on June 24, Russell Wesdyk, scientific coordinator for the FDA’s Office of Pharmaceutical Science, stressed that the FDA doesn’t intend to replace existing regulations but rather is looking to sharpen its focus under the existing regulatory umbrella. Read more on OPQ.

State Update

Massachusetts

Massachusetts Governor Deval Patrick yesterday signed into law comprehensive compounding pharmacy reform legislation, which allows Massachusetts to "better protect patients inside and outside the Commonwealth’s borders." The Act includes new licensing, labeling, education and oversight requirements, in addition to new penalties and fines for pharmacies who do not comply with the law.

“Every patient deserves to know that the medication they are taking is safe,” said Governor Patrick. “This law gives Massachusetts the strength and flexibility to better oversee compounding pharmacy practice and protect patients.” Click here to read the Governor's press release.

New Hampshire

An article appearing in the July 5th edition of the New Hampshire Union Leader provides an excellent summary of the problems that IACP has continued to point out on Capitol Hill and to the FDA…are 503B facilities subject to state oversight and, if so, how and to what extent? The Union Leader article details how New Hampshire is dealing with this problem; other states are taking completely different approaches. Click here to read the entire article.

Of interest? New Hampshire will no longer permit dual licensure of pharmacies and manufacturers. It will have to be one or the other which raises questions about whether a 503A compounding pharmacy that also is a 503B outsourcing facility will be allowed to dispense prescriptions for specific patients into New Hampshire… despite DQSA permitting them to do so. Another example of the federal vs. state authority issue which will eventually end up in the courts.  

IACP Hosts USP Chapter <800> Town Hall - Recording Now Available

Did you miss IACP's Town Hall this week on USP Chapter <800>? You can still listen to the recording, which is now available in the Members-only site. Click here to access the IACP Town Hall recording. 

Additional Information:

Click here for background on USP 800 call for comments

Click here to access actual USP 800 draft

Click here for document from NIOSH of Hazardous Drugs (from 2012, most current)  

COMMENTS LAST CALL: USP Proposed General Chapter <800> Hazardous Drugs - Handling in Healthcare Settings

The United States Pharmacopeia (USP) currently is seeking public review and comment on its proposed Chapter <800> Hazardous Drugs - Handling in Healthcare Settings. Click here to download this chapter with line numbers

All stakeholders are encouraged to submit comments with corresponding line numbers to
CompoundingSL@usp.org. Comments are due by July 31, 2014. 

IACP is preparing its comments to the USP, and will share with IACP members as soon as available. Please click here to view why it's important to submit comments. Please email IACP with questions at iacpinfo@iacprx.org.  

IACP Q&A

Every week, IACP members contact our offices for questions about practice, business, legislation and other issues.  Beginning with this issue of Capitol Connections, we'll highlight a question we've been asked that affects many of our members.  If you have a question you'd like answered, send that to iacpinfo@iacprx.org

This week's question comes from an IACP member in New Jersey regarding the "Do Not Compound List."

Does the "do not compound" list apply ONLY to humans or animals as well? There are several drugs on there that are still used for veterinary compounding and I want to be clear.

Answer: The "do not compound" list promulgated by the FDA applies only to human compounding. The Drug Quality & Security Act speaks solely to human prescription drugs, not veterinary products. 

Corporate Partner Spotlight: Topi-CLICK Topical Dosing Applicator

The patented Topi-CLICK Topical Dosing Applicator (TDA) combines an easy metering system for topical creams and gels with an integrated applicator pad to help apply 100% of the treatment onto the prescribed treatment area. Topi-CLICK's integrated applicator pad helps to overcome the non-compliance procedure of having to rub topical meds onto treatment areas with hands which may waste some of the topical medication when washed off. Recently a male topical testosterone drug was delayed approval by the FDA due to the concern of transference. The Topi-CLICK directly addresses these concerns with needed innovation. In addition, the audible clicker, visual indicators, and tactile dosing feedback features of the Topi-CLICK allow patients to easily dispense a metered dose in a matter of seconds…even in complete darkness. The seven available colors help differentiate patient treatments. All of these features can help improve compliance and thereby help create better outcomes. Demonstrations on Oprah, Dr. Phil and The Doctors national talk shows made the Topi-CLICK nationally recognized. See videos and more at www.Topi-CLICK.com.

To request a free starter kit email
info@Topi-CLICK.com or call 877-870-8448.

Registration will open August of 2014. Save the date! The ACA, IACP, ACVP Educational Conference returns to Fort Lauderdale in 2015

Don’t miss this one-of-a-kind, 3-in-1 conference that brings the pharmacy profession together in paradise. The American College of Apothecaries (ACA), the International Academy of Compounding Pharmacists (IACP) and the American College of Veterinary Pharmacists (ACVP) are joining forces again to bring you an extraordinary Educational Conference, February 25-28, 2015, at the ocean front property, the Harbor Beach Marriott Resort & Spa in Fort Lauderdale, Florida.

Click here for more details!

Start Planning Now to Attend #EduCon2015!

Reserve your hotel room now and receive the advance discount!

Start planning now!  Book your hotel room at the Harbor Beach Marriott Resort & Spa in Fort Lauderdale, Florida. The deadline to receive the hotel group rate is on or before 6:00 p.m. (EST) on Friday, January 23, 2015. 

Take advantage of airline and rental car discounts. Click here for the exclusive meeting discounts.

IACP Staff Announcement

IACP welcomes Macy Pruitt as the Events and Education Coordinator. Macy has joined the Events & Education Department and will oversee both IACP’s Regional Education Meetings and IACP AdvanCE’s live and self-paced online programming.  

As a May 2014 graduate from Texas Tech University, Macy holds a Bachelor of Arts in Advertising. During her senior year, Macy served as an Intern/Assistant Event Planner at Alström Angels, a non-profit dedicated to raising funds for Alström Syndrome. Throughout the course of her internship, she coordinated various fundraising events, and served as the primary event coordinator for the organization’s Community Blind Awareness Easter Egg Hunt.

If you have any questions, you may email Macy at macy@iacprx.org.

The Survey Says…

To better understand your needs, IACP recently conducted a survey on the current and potential future compounding continuing education opportunities. Based on the results, 99.12% said they would participate in an IACP Regional Education Meeting if it was within an hour or two from your home or practice. With your city recommendations and thanks to our hosts and sponsors, IACP will continue to expand and bring live pharmacy law to you with IACP Regional Education Meetings traveling the country. With 34.21% that said they have participated in an IACP AdvanCE webinar and 28.07% that said they may attend one in the future, IACP will continue to share opportunities with our State Pharmacy Associations and develop unique live and self-paced webinars on the latest topics affecting you and your practice.  

The survey results also indicated the two biggest factors in attending a live conference are the expenses involved and time away from your practice. With this in mind, we will continue to evaluate hotel locations and potential cities for the ACA, IACP, ACVP Educational Conference allowing you to experience CE from three leading pharmacy associations closer to home including special one-day pricing open to all local pharmacists, technicians, and marketers.   

Thank you to all for completing the survey. Your feedback is vital in our planning process. Stay tuned for more Continuing Education updates.

IACP Regional Education Meeting Heading to Atlanta, GA; and Dallas, TX

 

The IACP Regional Education Meeting brings 2.0 contact hours (.20 CEUs) of live pharmacy law continuing education credit to pharmacists and technicians all across the United States.  Listen to David G. Miller, RPh, IACP’s Executive Vice President & CEO as he presents, Pharmacy Compounding Law and Regulations: Staying Current in a Changing World, an in-depth presentation on federal and state legislative and regulatory issues that are affecting compounders today. Click here for more information!

IACP Calendar

IACP is your one-stop resource for all things compounding! Compounder Calendar provides a comprehensive listing of compounding events and continuing education programs. Click here to view IACP’s Upcoming Events.

IACP Career Center

Welcome to the IACP Career Center! Your destination for exciting job opportunities and the best resource for qualified candidates within the Industry. Click here to view the IACP Career Center.

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