|Capitol Connections March 21, 2014|
March 21, 2014
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 Announces Nominations for FDA’S Pharmacy Compounding Advisory Committee
The International Academy of Compounding Pharmacists (IACP) has submitted nominations to the U.S. Food and Drug Administration (FDA) for the Pharmacy Compounding Advisory Committee, a new panel that will advise the FDA on the implementation of the Drug Quality and Security Act.
Save the Date for IACP Town Hall on March 25th
Save the Date for Tuesday, March 25th for an IACP Member Town Hall: 3:00 pm EST – 2:00 pm CST – 1:00 pm MST – 12:00 pm PST
Topics Include: FDA Update; IACP’s API Bulk Drug List and FDA Pharmacy Compounding Advisory Committee Nominations; Progress on Constructive Transfer; New Marino Bill Update; and Compounders on Capitol Hill 2014 “Asks.” A blast fax with the call-in number has been sent to all IACP Members. You also can access this information in our Members-only site. Please email questions for this Town Hall to firstname.lastname@example.org.
TriCare Experiments with Mandatory Mail Order
As of March 14th, a TRICARE pilot program now requires certain TRICARE For Life (TFL) beneficiaries to use TRICARE Pharmacy Home Delivery or a military pharmacy to fill prescriptions for select maintenance medications. This pilot was a provision of the 2013 National Defense Authorization Act in an effort to help control rising healthcare costs.
Access the Latest State Updates with IACP's Compounders Stateside!
Click here for the latest edition of IACP's Compounders Stateside. IACP is now monitoring 61 pieces of legislation on behalf of IACP Members! That's only 3 short of last year's 64 bills.
IACP Joins Coalition Applauding Introduction of Legislation to Increase Patient Access to Pharmacist Services, Within State Scope of Practice, in Medically Underserved Communities
IACP has joined the Patient Access to Pharmacists’ Care Coalition (PAPCC) – a group of more than 20 organizations representing patients, pharmacists, and pharmacies, as well as other interested stakeholders – issued the following statement today on the introduction of legislation in the U.S. House of Representatives to recognize pharmacists and their patient care services under Medicare Part B:
The Horse Magazine Interviews IACP's David Miller
IACP's David G. Miller, RPh, Executive Vice President/CEO, sat down with The Horse's Christy Corp-Minamiji, DVM, to discuss compounding, why it's valuable for veterinarians and their patients, and, importantly, how it's regulated. IACP is continuing to meet with a variety of publication editors to help raise awareness of pharmacy compounding, and why it's a vital part of health care for both human and animal patients.
"We were particularly pleased with the balanced nature of this article as The Horse's editorial traditionally has been significantly negative," says Miller.
Call for Nominations: IACP Task Force on Veterinary Compounding Legislation
Nominations are now open for a new 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.
IACP Going to APhA Annual Meeting & Exposition
If you are going to the American Pharmacists Association (APhA) Annual Meeting & Exposition, March 28 -31, 2014, in Orlando, Fla, please stop by the IACP Booth (#332), and say, “Hi!” We’d love to see you and hear your ideas about what IACP can do for you. While you are there, talk with IACP's David G. Miller, RPh. More on APhA's Meeting at www.pharmacist.com.
IACP to Present at the Association of Compounding Pharmacists of Canada, April 26th
IACP's David G. Miller, RPh, will present, "What is New in Compounding through the Eyes of IACP?" on April 26, 2014, at 3 pm in Mississauga, Ontario, Canada, at the Association of Compounding Pharmacists of Canada (ACPC) General Meeting. Click here for the ACPC Meeting Program. Click here for a registration form. Click here for the ACPC Newsletter.
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: The Prep-LockTM Tamper Evident Syringe Cap from International Medical Industries, Inc.
Compounded sterile preparations (CSPs) are at their greatest risk when they leave the custody of your pharmacy. The Prep-Lock Tamper Evident IV Syringe Cap from IMI greatly reduces the risk of your CSP being compromised either accidentally or intentionally. It insures that product integrity is maintained from the time it leaves the sterile hood until it is administered by an authorized clinician.
Installation of the Prep-Lock Tamper Evident IV Syringe Cap in your compounding operation is highly efficient. Each sterile tray of 10 caps offers a unique “keyed” feature allowing the pharmacist the ability to quickly install the cap with a simple twist of the syringe. This helps to maintain aseptic technique and saves time when compounding several syringes at once. Click here to read more!
Corporate Partner Spotlight: RxCoop LLC
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; 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; EMD Millipore; 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); 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 Medical Industries, Inc (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); 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: Judicial Sponsor: Eddie Glover, PD, US Compounding, Conway, AR; John Herr, RPh, FIACP, Town & Country Compounding, Ridgewood, NJ; Rakesh Patel, PharmD, 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; David Creecy, RPh, Poquoson Pharmacy, Poquoson, VA; Steve Hoyt, RPh, Owner, San Ysidro Pharmacy, Santa Barbara, CA; Richard Johnson, Pharmacist/Owner, Compounding Specialists of Wyoming, Casper, WY; 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; Tiffany Turner, Freedom Pharmaceuticals, Broken Arrow, OK; Doug Yoch, PharmD, Stanley Specialty Pharmacy, Charlotte, NC.
To learn more about the exhibitors and meeting sponsors, click here.
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. For more information, please visit www.iacprx.org/RegionalEducationMeetings.
Scottsdale, Arizona – March 21, 2014
6:30 - 9:00 p.m.
FireSky Resort & Spa, Sun and Moon Meeting Rooms
4925 North Scottsdale Road, Scottsdale, AZ 85251
Click Here to View the Event Flyer for More Details!
Joint Registration with the 2014 Functional Medicine Conference: This meeting is held in conjunction with the 2014 Functional Medicine Conference presented by ZRT Lab and Storey Marketing, to be held March 21-23, 2014 at the FireSky Resort & Spa in Old Town Scottsdale, AZ. A discounted package rate with Friday’s Marketing Update and/or the 2014 Functional Medicine Conference is available. Please visit www.functionalmedconference.com for more information and to register for the discounted package rates.
Registration for the IACP Regional Education Meeting in Scottsdale Only: $20 for IACP Members, $40 for Non-Members, and Free for Pharmacy Students
This program is made possible through an unrestricted educational grant-in-aid from Storey Marketing.
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.
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.
What you can expect in 2015:
By morning – experience a unique menu of CE programs merging the best of ACA, IACP and ACVP. Gain information and skills you can implement immediately to your pharmacy practice.
By afternoon – connect with your colleagues and enjoy an array of thrill-seeking water adventures, a luxurious day spa and dine overlooking the Atlantic Ocean at the pristine ocean front property, the Harbor Beach Marriott Resort & Spa in Fort Lauderdale, Florida.
This is destination education at its finest. We’ll send you and your staff back to your practice energized, motivated and ready to conquer the world!
February 25-28, 2015
Harbor Beach Marriott Resort & Spa
Fort Lauderdale, Florida
Here’s an opportunity to let your patient and prescriber communities know that you will be attending the Educational Conference in 2015! Promote the Conference on your pharmacy or company website, Facebook page and even in print! Attendees and Corporate Partners are all encouraged to promote their support by using the Graphic Toolkit. The Educational Conference Graphic Toolkit includes a logo/web banner, Facebook Cover Image, “I’m Attending” e-mail signature as well as a full page, ¼-page and ½-page print ads.
To download the Educational Conference Toolkit, 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.
Tell us how compounded pharmaceuticals have helped you, someone you know, or how you have helped someone as a practicing compounding pharmacist. Help us protect your continued access to pharmacy compounding!
Share the P3 community and the value and necessity of personalized prescriptions with your friends.