September 5, 2014
IACP Files Comments on 503A and 503B
IACP Submits Comments on FDA's Draft Guidance for Industry on Current Good Manufacturing Practice—Interim Guidance for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug and Cosmetic Act
On September 2nd, IACP filed comments regarding the FDA's "do not compound" list focusing primarily on the agency's circumvention of the Pharmacy Compounding Advisory Committee and a lack of procedures for adding or modifying the list in the future - 503A.
IACP also filed the second of two IACP formal comments to FDA - FDA's Interim Guidance for Human Drug Compounding Outsourcing Facilities 503B.
Please click here to read IACP's FDA comments regarding 503A, and the "Do Not Compound" list.
Please click here to read IACP's extensive comments to FDA regarding 503B.
IACP Provides Timely AdvanCE Webinar on CGMPs
Register today to attend IACP’s September live webinar Current Good Manufacturing Practices – A Compounding Pharmacy Perspective, presented by Matt Bestercy and Nancy Daniels. This one-hour webinar will discuss the importance of the Food & Drug Administration (FDA) Code of Federal Regulations, Current Good X Practices (CGXPs), and how they impact the compounding pharmaceuticals industry.
With more and more compounding pharmacies being inspected and held to CGMP standards by the FDA, this webinar is a "must" to understand what the differences are between them and, USP <795> and <797>. For any IACP member considering opening or working for a 503B outsourcing facility, this educational program will provide a solid basis in the "new world" of working under CGMPs in those entities. Click here for more information and to register.
DEA Reschedules Hydrocodone from Schedule III to Schedule II
Final Rules - 79 FR 49661
Schedules of Controlled Substances: Rescheduling of Hydrocodone Combination Products From Schedule III to Schedule II
Regulating Agency: Department of Justice, Drug Enforcement Administration
Publication Date: 08/22/2014
With the issuance of this final rule, the Administrator of the Drug Enforcement Administration (DEA) reschedules hydrocodone combination products from schedule III to schedule II of the Controlled Substances Act.
This scheduling action is pursuant to the Controlled Substances Act which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. This action imposes the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule II controlled substances on persons who handle (manufacture, distribute, dispense, import, export, engage in research, conduct instructional activities with, conduct chemical analysis with, or possess) or propose to handle hydrocodone combination products. Please click here to read more.
Access the Latest State Updates with IACP's Compounders Stateside
State Compounding Legislation Tracker
Click here for a comprehensive document with up-to-date compounding activity in your state. Document contains all 79 of the compounding bills that were in process this year.
NEW Click here for "IACP Enacted and Pending State Legislation Affecting Compounding 09012014," contains only those bills that were actually enacted (17) and a separate section at the bottom containing the list of bills that are still "pending" upon resumption of the state's legislature after their recess (22 of those). This is a brand-new IACP report for members to advise "what has changed."
IACP’s Compounders StateSide is a one-stop resource for state legislative and regulatory updates and the latest happenings with state Boards of Pharmacy. Click here for complete Compounders Stateside information.
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 email@example.com
This week's question comes from an IACP member regarding international shipments.
Question: Can I ship a compounded preparation to a physician or patient in another country?
Answer: The distribution of prescription drugs internationally is extremely complex. It involves both exportation and importation laws, licensure requirements in both the pharmacy's home state and potentially professional or business permits in the country of receipt, and potential impact on accreditation status.
The Food and Drug Administration, along with the US Customs Service, has federal authority over both importation of drugs into the US as well as exportation of drugs from the US. The Federal Food, Drug, and Cosmetic Act prohibits the interstate shipment -- which includes importation and exportation -- of unapproved new drugs. Thus, the importation of new drugs that lack FDA approval, whether for personal use or otherwise, violates the Act. Similarly, exportation of unapproved new drugs is also prohibited. Unapproved new drugs include any drugs--including foreign-made versions of U.S. approved drugs--that have not been manufactured in accordance with FDA approval. The FDA considers all compounded medications to be unapproved new drugs and therefore would consider the exportation or shipment of either a patient-specific or an office-use compounded preparation to be a violation of the FDCA. Additional details on the rules regarding exportation, including registration, permits, and other FDA requirements, is detailed in Guidance for Industry: Exports Under the FDA Export Reform and Enhancement Act of 1996.
Click here for more.
Corporate Partner Spotlight: Freedom Pharmaceuticals
Supporting YOU from Every Angle!
Freedom Pharmaceuticals, Inc. specializes in the custom wholesale distribution of premium compounding chemicals – active pharmaceutical ingredients (APIs), excipients and pre-made bases – to independent compounding pharmacies throughout the United States. We are continually expanding our product offering based on our customer’s needs. Our team of experts has over 100 years of combined experience.
At Freedom, our goals are simple: supply your compounding pharmacy with the highest quality fine chemicals available and give your staff the personalized customer service necessary to operate successfully in this rapidly changing industry. Built on the belief that customer service and quality chemicals are paramount, Freedom Pharmaceuticals strives to meet the ever changing demand of independent compounding pharmacies and their patients. Our commitment to quality and exceptional customer service is evident in all we do. At Freedom, we have our finger on the pulse of compounding and we help our customers remain on the forefront of this rapidly changing industry.
Click here to read more.
CCH Save the Date Postcard Coming Soon! Check Out New Meeting Highlights at the 2015 Compounders on Capitol Hill
The 21st Annual Compounders on Capitol Hill (CCH) will be held June 6-9, 2015 at the Renaissance Washington, in Washington D.C. With more than 400 expected attendees in 2015, Compounders on Capitol Hill brings together the top-level compounding pharmacists and technicians from across the country with the same goal – to protect pharmacy compounding. Don’t miss the only pharmacy compounding event that takes our issues directly to Washington, D.C.’s doorstep.
Click here to read more!
2015 Educational Conference Registration Now Open
Connect and network with fellow colleagues. #EduCon2015
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.
Why should you attend the Educational Conference 2015?
“I'm attending the Educational Conference because it's a great place to network and on my free time I'm planning on playing a little golf with some fellow pharmabuds.”
- Kevin Borg, PharmD, FIACP, Potter's House Apothecary (Peoria, AZ).
Click here for more details!
Two New Pharmacy Student Activities at the 2015 Educational Conference
Participate in the Educational Conference Spring 2015 Student Writing Competition
Essay Topic: Discuss the importance of being involved in a professional association as you’re starting your career.
The ACA, IACP, ACVP Educational Conference announces the Spring 2015 Student Writing Competition to recognize original papers on a particular topic affecting the future of independent pharmacy. Two winners will be selected by a review committee from the papers submitted. Thanks to the generosity of donors of both the ACA Foundation and IACP Foundation, the winners of this writing competition will each receive a scholarship to attend the Educational Conference February 25-28, 2015 in Fort Lauderdale, Florida. All pharmacy students are encouraged to compete.
Click here to download the Spring 2015 Student Writing Competition Flyer.
Essay Topic: Why networking with professional colleagues helps identify career paths for pharmacy students.
Through the generosity of donors to Fund-the-Future at the annual Rx Mixer in 2014, the IACP Foundation will be offering five pharmacy students a scholarship to attend the Educational Conference February 25-28, 2015, in Fort Lauderdale, Florida. All pharmacy students are encouraged to compete.
Click here to download the IACP Foundation Fund-the-Future Scholarship Application.
Meet the 2015 Exhibitors
The Educational Conference Exhibitor Experience has expanded to 29 exhibiting companies. Discover how you can work with them before you arrive. To learn more about ICA Health and their services to help you effectively manage and grow your business, check out the video below. Make sure to stop by their booth when visiting the Exhibit Hall. For more videos from the Educational Conference exhibiting companies, visit our YouTube page at http://bit.ly/VSUFvX. Subscribe to the Educational Conference YouTube page as new videos will be added frequently.