|Capitol Connections April 4, 2014|
April 4, 2014
House Health Subcommittee of the Energy and Commerce Committee to Hold Hearing on HR 4069
The House Health Subcommittee of the Energy & Commerce Committee will hold a hearing on HR 4069 introduced by Congressman Thomas Marino (R-PA). The hearing is scheduled for Monday, April 7, 2014, at 3:00 p.m. in Room 2123 of the Rayburn House Office Building. The hearing is entitled “Improving Predictability and Transparency in DEA and FDA Regulation.” The Drug Enforcement Administration (DEA) is expected to testify.
IACP Summary Available: President Obama Releases his Budget Requesting $4.7 Billion for FDA
The President released his budget on March 4th, requesting $4.7 billion for the Food and Drug Administration (FDA), which is $358 million, or 8% above the FY 2014 Enacted level. The President specifically requested $25 million of the total for agency-wide oversight of drug compounding, including enforcement, inspections, and collaboration with States. Click here to read IACP's comprehensive Summary of the FDA FY 2015 Budget.
U.S. House Releases FY2015 Budget Plan
The U.S. House of Representatives this week released its FY2015 budget plan. IACP currently is reviewing the plan for any compounding requests. Click here for more information from the House.
Bloomberg BNA Interviews IACP's David Miller
IACP's David G. Miller, Executive Vice President/CEO, is featured in an in-depth March 20, 2014, Bloomberg BNA article, "States Adopt Variety of Oversight Strategies in Wake of NECC Disaster." Miller explains the current environment of states updating their regulations over the past year since the NECC tragedy. Click here to read the article. It's a long, detailed article; but, worth the time to read!
CVS & Federal Government Relationship Extends to 2017
According to a March 26th PR Newswire announcement - CVS Caremark Corporation announced that it has been awarded a three-year contract to provide integrated pharmacy benefit services for the Blue Cross and Blue Shield Government-wide Service Benefit Plan, also known as the Federal Employee Program (FEP). The Company will continue to provide retail pharmacy benefit management services, mail service pharmacy, specialty pharmacy services and highly customized clinical programs to FEP's more than 5 million federal employees, retirees and dependents. The new agreement, which runs through 2017, brings the relationship between CVS Caremark and FEP to more than 20 years.
What to Consider if Compounding for Prison Executions
There are several business issues to consider when approached to compound a medication used for executions that are separate from the ethical and legal ones.
In Case You Missed It: FDA Responds to IACP Outsourcing Letter
IACP has been closely monitoring the U.S. Food & Drug Administration's (FDA) communications and activities regarding the newly established Outsourcing Facilities (OF). We are concerned regarding several areas on which we believe FDA has failed to provide guidance, causing considerable confusion for pharmacies. For example, the FDA sent letters to the States and to hospitals requesting that the hospitals only do business with registered OFs. FDA also asked States to implement a requirement that anyone who ships into their state to be registered as an OF. However, FDA hasn’t inspected any of these recently registered OFs; they have delayed the reporting requirements to OFs that register; and, FDA hasn’t developed any of the lists that dictate what OFs can compound. In addition, FDA hasn’t clarified with any pharmacies wishing to register as OFs whether they have to comply with the cGMPs, or whether FDA is drafting an alternative standard that will be enforced at these OFs. Thus, OFs are being asked to register, and they don’t even know to which standard of compliance they will be held.
All pharmacies and pharmacists are licensed and strictly regulated by State Boards of Pharmacy. Compounding is a core component of pharmacy and has always been subject to the oversight and monitoring of these agencies and the state legislatures who decide upon the way pharmacy compounding should be regulated within their borders. Additionally, the Food & Drug Administration has authority over some aspects of compounded prescriptions at the federal level under the direction of Congress. Standards set by the United States Pharmacopeia (USP) are integrated into the day-to-day practice of pharmacy compounding and are mandated by law in most states. Even greater oversight comes through accreditation from a variety of non-profit agencies that establish and survey on guidelines designed to improve quality in the compounding process.
Click here for FDA’s letter to hospitals promoting OFs
See Inside Health Policy article below.
Jurisdictional Issues Surface As States Mull Outsourcing-Facility Licensing
States are confused about how to apply licensing requirements to FDA's newly created category of outsourcing facilities, an International Academy of Compounding Pharmacists official said, citing an area that needs clarification as FDA implements the Drug Quality and Safety Act (DQSA). Sen. Lamar Alexander (R-TN), ranking member of the Senate health committee, recently touched on the issue in a hearing, saying states are considering laws that would also regulate outsourcing facilities.
Miller pointed to bills being considered in Florida and California that would prohibit nonresident compounding pharmacies from shipping drugs into the state without a license or a permit. These measures could also affect firms registered with FDA as outsourcing facilities. The Florida bill specifies that outsourcing facilities must hold a state permit to distribute in the state.
Other states, Miller said, don't know what to do. "Both flags are on the flagpole" for outsourcing facilities, he said, using an analogy made by lawmakers.
The intent of DQSA was to allow companies to choose to be regulated by the state or FDA, Alexander said, pressing FDA commissioner Margaret Hamburg for details about state laws applying to outsourcing facilities.
DQSA, which was passed last year, created a new section, 503B of the Food, Drug and Cosmetic Act, in which large compounding pharmacies can voluntarily register with FDA and meet federal requirements for quality and inspections. Compounding facilities that do not to register must comply with manufacturing exemptions under section 503A, or be considered a drug manufacturer. The law was intended to clear up state and federal jurisdictional issues that were at issue during a deadly nationwide outbreak tied to drug compounding.
So far, 33 facilities are registered as outsourcing facilities, according to FDA records.
At the hearing, Hamburg also said that there are holes in the regulatory oversight of large compounding pharmacies. She said she is concerned that compounding pharmacies who aren't registered with the agency could be out of compliance with provisions of the law, but FDA may not know they even exist.
Hamburg also told the senator that the Good Manufacturing Practices (GMP) guidelines for outsourcing facilities under 503B is a top priority for the agency and they will be released as quickly as possible.
FDA Tells Congress "No Office-Use"
In addition to all the confusion surrounding Outsourcing Facilities (OFs), pharmacies have been told that office-use would continue to be governed under State laws. Specifically, there are more than six Statements on the Record from both the House and Senate stating that FDA does not have jurisdiction to prohibit pharmacies for compounding for office-use (or for the administration within a doctor’s office or hospital), and that it's an issue that should be left to the States.
FDA recently sent the House Energy & Commerce (E&C) Committee responses to Questions for the Record (QFRs) stating that despite the Congressional intent, FDA will use its “discretion” to prohibit all office-use compounding by pharmacies under 503A. FDA also has begun sending warning letters that express to pharmacies that solely based on the fact they are compounding for office-use for doctor’s office and/or hospitals, that they are a manufacturer and thus, in violation of the Food, Drug, and Cosmetic Act. This is represents a huge concern for pharmacies and Congress. To respond, it is IACP's understanding that Congressman Morgan Griffith (R-VA) intends to send a letter to FDA that expresses concern and disappointment with FDA’s most recent actions on prohibiting office use.
Click here for FDA’s most recent responses to the House E&C Committee regarding prohibiting office-use (the answer from FDA is on page 10)
IACP March 25th Town Hall Recording Now Available
Thanks to the 91 member participants who joined our recent Town Hall call! If you missed IACP's Member Town Hall held on Tuesday, March 25th, the recording of the entire session is now available.
Last Call for Nominations: IACP Task Force on Veterinary Compounding Legislation
Nominations will end today at 12 a.m., for the IACP Task Force on Veterinary Compounding Legislation. IACP is searching for individuals who are experts and knowledgeable in veterinary pharmacy compounding, and the needs of the veterinary practitioner. IACP's Task Force will develop a legislative proposal on veterinary compounding.
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
From the IACP AdvanCE Self-Paced Library: Don't Mess with Uncle Sam! How the Stark Law and the False Claims Act Impact Pharmacists
Glaxo Smith Kline -- $3 billion. Abbott -- $1.6 billion. J&J -- $2 billion. Those are the penalties just three drug companies have paid for violating the federal False Claims Act. Did you know that what got them into trouble was making claims about their drugs to prescribers for unapproved uses? But when many pharmacists hear the word “claims,” they believe the False Claims Act has to do with marketing. It doesn’t. It covers every single transaction between a provider of goods and services paid for by the federal government. That’s “claims” as in filing a claim for money. So, if you bill Medicaid or Medicare, the VA, or the Federal Employees Prescription Benefit Program, you are just as liable for violations of the False Claims Act as a major manufacturer. Unless you have a billion dollars or so just lying around, this is a must-attend webinar to protect yourself and your business from making costly mistakes.
Because any allegation of potential overbilling to a federal funded prescription or health benefit program – Medicaid, Medicare, TriCare, the Veterans Administration, the Federal Employees Health Plan – can be gravely serious, IACP offers members a self-paced webinar, Don’t Mess with Uncle Sam! How the Stark Law and the False Claims Act Impact Pharmacists. The Stark Law (also called the Anti-Kickback Law) and the False Claims Act impact every pharmacy that fills a prescription and bills a federally funded program and also any pharmacy who has a sales or marketing person generating compounded prescriptions which also result in a billing for physician services to those programs. To view this invaluable self-paced webinar, please click here.
Corporate Partner Spotlight: LicenseLogix
LicenseLogix helps pharmacies get licensed and stay licensed.
Take Part in Insightful Continuing Education Sessions that Provide Tools and Resources to Advance Your Practice!
20th Annual Compounders on Capitol Hill
May 17-20, 2014
Crystal Gateway Marriott
Thank you to Our Exhibitors and Meeting Sponsors!
We would like to thank the following exhibitors for their commitment to Compounders on Capitol Hill: Accreditation Commission for Health Care (ACHC); AirClean Systems; American College of Apothecaries (ACA); Analytical Research Laboratories (ARL); Associates of Cape Cod, Inc.; ATS Labs; Attix Pharmaceuticals; B&B Pharmaceuticals, Inc.; Blesstia Pharmaceutical; Campbell University-Pharmaceutical Education and Research Center; Diversified Pharmaceutical Ingredients, LLC (DPI); DYNALABS; Eagle Analytical Services; EXAKT Technologies, Inc.; Fagron; Feras Health, LLC; Freedom Pharmaceuticals, Inc.; Frier Levitt LLC; Fuji Health Science, Inc.; Health Engineering Systems (HES); Humco Compounding; International Journal of Pharmaceutical Compounding (IJPC); International Medical Industries, Inc (IMI); KUNESA LLC; Letco Medical; Live Oak Bank; Medi-Dose, Inc./EPS, Inc.; MEDISCA; National Community Pharmacists Association (NCPA); Pharmacy Compounding Accreditation Board (PCAB); PCCA; Pure Encapsulations; RXinsider; RX TaxPros; RxCoop, LLC; Storey Marketing; Tacit Almonds, LLC; TeleManager Technologies; U.S. Pharmacopeial Convention (USP); Wellness Works; ZRT Laboratory.
We would like to thank the following meeting sponsors for their support of Compounders on Capitol Hill: American College of Apothecaries (ACA) (Continuing Education Provider); Analytical Research Laboratories (ARL) (Education Session); Attix Pharmaceuticals (First Timer Program); B&B Pharmaceuticals, Inc. (Meeting Tote Bag); Fagron (Meeting Syllabus); Freedom Pharmaceuticals, Inc. (Meeting Brochure/Commemorative Travel Mugs); Humco Compounding (Education Session/Door Drop Bag Insert); International Journal of Pharmaceutical Compounding (IJPC) (Education Session); International Medical Industries, Inc. (IMI) (Door Drop Bag Insert); Letco Medical (Welcome Reception Honoring IACP fellows/Education Session/CCH Lapel Pin); MEDISCA (Meeting T-shirt; Education Session); Microtest Laboratories, Inc. (Education Sessions (2)); PCCA (Hotel Room Keys/Name Badge Holder/Education Sessions (2)/Exhibitor and Monday Continental Breakfast & Lunch Sponsor); ProPharma Group (Door Drop Bag Insert); RX TaxPros (Education Session); Tacit Almonds, LLC (Relaxation Station); Torrey Hills Technologies, LLC (Education Sessions (2)); Topi-CLICK Topical Dosing Applicator (Conference Notepad/Pen Combo).
We would like to thank the following individual and pharmacy meeting sponsors for their support of Compounders on Capitol Hill: Presidential Sponsor: Darby Brown, RPh, PIC, Brown’s Compounding Center, Englewood, CO; Judicial Sponsor: Eddie Glover, PD, US Compounding, Conway, AR; John Herr, RPh, FIACP, Town & Country Compounding, Ridgewood, NJ; Rakesh Patel, RPh, WELLHealth Rx, Jacksonville, FL; Stan Reeves, PharmD, F & F Drugs, Demopolis, AL; Contributor Sponsors: Eyad Alsabbagh, Dr, Biomed Specialty Pharmacy, West Chester, OH; Mike Boehmer, RPh, Director, Compound Pharmaceutical Technologies, Daphne, AL; Kevin Borg, President/CEO, PharmD, FIACP, FACA, Potter's House Apothecary, Peoria, AZ; Denise Burnham, RPh, Creative Compounds, Wilsonville, OR; Greg Chase, Pharmacist/Owner, Akina Pharmacy, Chantilly, VA; David Creecy, RPh, Poquoson Pharmacy, Poquoson, VA; Saad Dinno, RPh, FIACP, FACA, Acton Pharmacy, Acton, MA; Steve Hoyt, RPh, Owner, San Ysidro Pharmacy, Santa Barbara, CA; Brenda Jensen, CPhT, Compounding Consultants, LLC, Canton, SD; Richard Johnson, Pharmacist/Owner, Compounding Specialists of Wyoming, Casper, WY; Joe Lorello, RPh, Principal, Apothecary by Design, Portland, ME; Linda McElhiney, PharmD, RPh, FIACP, FACA, FASHP, Indiana University Health, Indianapolis, IN; Brenda Pavlic, CPhT, SaveWay Compounding, Newark, DE; Baylor Rice, RPh, FIACP, South Compounding River Pharmacy, Richmond, VA; Gener Tejero, RPh, Solutions Specialty Pharmacy, Las Vegas, NV; Tiffany Turner, Freedom Pharmaceuticals, Broken Arrow, OK; Doug Yoch, PharmD, Stanley Specialty Pharmacy, Charlotte, NC; Thomas Zieglar, RPh, Owner/PIC, Medicap Pharmacy, Ashburn, VA.
To learn more about the exhibitors and meeting sponsors, click here.
The IACP Corporate Partner program engages corporate leaders in the pharmacy compounding community by connecting them with more than 3,600 IACP affiliates who are focused upon the specialty practice of pharmacy compounding. We encourage all IACP members to support these corporate partners who are instrumental in our joint effort to protect and grow this vital part of quality healthcare.
Join Polsinelli's Live Webinar on Tuesday, April 8, 2014, New Compounding Pharmacy Law: Compliance Issues for Business and Risk Analysis for Investors. Click here for more information!
To learn more about Polsinelli PC, please visit www.polsinelli.com.
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.
Attendees will learn how regulatory initiatives and court decisions have influenced the regulation of compounders, the authority of the Food and Drug Administration (FDA) when inspecting compounding pharmacies, and up-to-date information on the current federal proposed legislation. Are YOU current on your compounding pharmacy law? Never assume.
We hope you’ll join us for an evening of compounding pharmacy law education, Q&A, and networking with your local compounders! For more information, please visit www.iacprx.org/RegionalEducationMeetings.
Newark, New Jersey – June 18, 2014
7:00 - 9:30 p.m.
NJIT Enterprise Development Center, #407 (EDC Conference Center)
211 Warren Street, Newark, New Jersey 07103
IACP Members: $50; Non-Members: $75; Student Pharmacists: FREE
Thank you to TeleManager Technologies for hosting this meeting.
Atlanta, Georgia – September 9, 2014
7:00 - 9:30 p.m.
Mercer University’s College of Pharmacy
3001 Mercer University Drive, Atlanta, GA 30341
FREE! This seminar is open to pharmacists, technicians, marketing representatives, and pharmacy students at no cost thanks to Topi-CLICK Topical Dosing Applicator and Mercer University’s College of Pharmacy.
This program was made possible through an unrestricted educational grant-in-aid from Topi-CLICK Topical Dosing Applicator.
Thank you to Mercer University’s College of Pharmacy for hosting this meeting.
Dallas, Texas – September 20, 2014
Omni Hotel in Dallas
IACP Members: $50; Non-Members: $75; Student Pharmacists: FREE
This meeting will correspond with the Freedom Pharmaceuticals, Inc. 3rd Annual Seminar, September 18-20.
Would You Like to Sponsor or Host an IACP Regional Education Meeting in Your City?
If you would like IACP to plan a Regional Education Meeting in your city, please email Michelle Greene Atkinson or call 281.933.8400. For more information on sponsorship, please click here. For more information on hosting, please click here.
IACP is your one-stop resource for all things compounding! CompounderCalendar provides a comprehensive listing of compounding events and continuing education programs. Click here to view IACP’s Upcoming Events.
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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