Tuesday, September 4, 2012
Seventh Annual FDA Inspections Summit
September 19-21, 2012
Click here for more information
Each year, the FDA makes adjustments to its inspection processes and policies. This year is no exception. Recent important changes include:
- If you think you can easily stop the FDA from taking pictures of your facility during an inspection, think again. The FDA now advises its inspectors to not ask for permission but take their cameras into facilities and take pictures as they see fit. If a firm complains, the new policy is for the inspector to contact the firm’s legal counsel and advise the district management immediately.
- A new user fee may be assessed if FDA conducts a reinspection to evaluate corrective actions that were classified Official Action Indicated (OAI) and determined to be material. This fee may also be assessed for not complying with a recall order issued by FDA under section 423 or 412(f).
- FDA investigators are actively data mining your records during inspections. As nearly all inspectors are using laptops and tablets during their inspections, many are asking for electronic copies of complaint or AER data and taking it back to their hotel rooms each evening to dissect the data and be prepared to ask additional questions the next morning. Providing old or inaccurate data can quickly lead to problems.
These changes and many more are to be discussed at the Seventh Annual FDA Inspections Summit. Year after year, the crème de la crème of the industry make it their business to attend this conference and tap into the cumulative knowledge of an accomplished group of top officials from CDER, CDRH, CBER, the Office of Regulatory Affairs (and more).
Register today to hear about breaking news directly from prominent FDA officials. That's why you can't afford NOT to attend the Seventh Annual FDA Inspections Summit on Sept. 19-21 in Bethesda, MD.
Featured Speakers:
- Steve Silverman, Director, Office of Compliance, CDRH, FDA
- Lori Lawless, SCSO, Medical Device Specialist, ORA, FDA, Baltimore District
- Mary Malarkey, Director, Office of Compliance Biologics Quality, CBER, FDA
Summit Faculty:
- Barbara Immel, President, Immel Resources (Summit Chairperson)
- Steve Niedelman, Lead Quality Systems and Compliance Consultant, FDA & Life Sciences Practice, King & Spalding, former Deputy Associate Commissioner, Regulatory Operations and Chief Operating Officer, ORA, FDA
- Ron Johnson, President, Becker & Associates Consulting, Inc., former Director of Compliance, CDRH, FDA
- Dr. Gilda D’Incerti, CEO, Pharma Quality Europe
- Deborah Geyman, Senior Manager Corporate Quality Audit, St. Jude Medical
- Dr. Stephen Goldman, Managing Member, Stephen A. Goldman Consulting Services, formerly FDA’s first Medical Director of MedWatch
- Steven Grossman, President, HPS Group, Deputy Executive Director, Alliance for a Stronger FDA, Publisher, FDA Matters: The Grossman FDA Report, former Deputy Assistant Secretary for Health, HHS
- Connie Hoy, Vice President, RA/QA, Cutera
- Julie Larsen, Director, Inspection Readiness Services, BioTeknica
- Dr. Jeanne Mattern, Director, QHS Regulatory Compliance Office, Cleveland Clinic
- Dan O'Leary, President, Ombu Enterprises
- Matt Quirk, Manager, Clinical QA, St. Jude Medical
- Kenneth White, Principal Scientist, Clinical Research and Bioscience Group, Social & Scientific Systems
- Christina Arnt, Post Market Surveillance Manager, St. Jude Medical
- Braulio Ortiz, Principal/Sr. Quality Consultant, BioTeknica
- David Elder, Vice President of Strategic Compliance Services, PAREXEL Consulting
- Elaine Messa, Executive Vice President of the Medical Device Practice, Becker & Associates Consulting, Inc.
- Michael Bloh, Independent Safety and Pharmacovigilance Consultant
- Frederick Branding, Principal Attorney, Olson Frank Weeda
- Scott Cunningham, Partner, Covington & Burling
- Darshan Kulkarni, Principal Attorney, The Kulkarni Law Firm
- Cathy Burgess, Partner, Alston & Bird
Click here for more information
Continued NABP Actions Vital to Protecting Public from Rogue Internet Drug Outlet Dangers, Task Force Advises
Continued NABP Actions Vital to Protecting Public from Rogue Internet Drug Outlet Dangers, Task Force Advises
Originally published in the August 2012 NABP Newsletter
Applying for the .pharmacy generic Top-Level Domain (gTLD), supporting relevant legislation, and educating consumers, health care providers, and law enforcement, are among the many actions NABP should continue to undertake in order to protect the public health from Internet drug outlets, as agreed by the 2011-2012 NABP Task Force on Internet Pharmacy Practice. Task force members discussed the complex network of operations behind rogue Internet drug outlets to determine how such entities can be shut down, and made several recommendations in this regard. Further, members discussed the importance of continuing to share NABP’s research findings on rogue Internet drug outlets with both United States and international regulators, law enforcement, and other stakeholders. Members also agreed that the Association should take additional actions to support boards of pharmacy efforts to help shut down rogue Web sites illegally selling drug products.
The Task Force on Internet Pharmacy Practice met March 6-7, 2012, at NABP Headquarters and accepted their charge as follows:
- Review existing Internet pharmacy practices;
- Review current state laws and regulations, Verified Internet Pharmacy Practice SitesCM (VIPPS®) program standards, and NABP Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy language; and
- Examine future opportunities and challenges in an emerging global environment.
The full article includes a summary of the task force recommendations, as well as background information, and is available in the August 2012 NABP Newsletter (PDF) (page 151).
American Society of Health Care Pharmacists Policy Analysis: Track-and-Trace Federal Legislation
Following Pharmaceutical Products Through the Supply Chain
By Lisa A.Daigle, M.A., Policy Analyst
August 2012
Electronic tracking of pharmaceutical products would improve the integrity of the supply chain,enable health care providers to more quickly identify and remove counterfeit and recalled drugs, and improve inventory management.Florida1 and California2 have pharmaceutical pedigree laws,with California’s law inspiring federal legislation that would require an electronic pedigree and track-and-trace system forpharmaceutical products.3
The federal bill proposes establishing a central database where the information from electronic pedigrees would be stored and accessed.
To read remainder of article click here.
By Lisa A.Daigle, M.A., Policy Analyst
August 2012
Electronic tracking of pharmaceutical products would improve the integrity of the supply chain,enable health care providers to more quickly identify and remove counterfeit and recalled drugs, and improve inventory management.Florida1 and California2 have pharmaceutical pedigree laws,with California’s law inspiring federal legislation that would require an electronic pedigree and track-and-trace system forpharmaceutical products.3
The federal bill proposes establishing a central database where the information from electronic pedigrees would be stored and accessed.
To read remainder of article click here.
Kentucky: Pain Clinic Owners and Doctors Charged in Prescription Drug Conspiracies
PIKEVILLE-Between today and late Thursday afternoon, five indictments have been unsealed charging 22 defendants, including five pain clinic owners and six doctors, with offenses related to prescription drugs, money laundering, and health care fraud.
Former Owner of Daytona Beach Clinic Pleads Guilty To Fraud, Conspiracy, and Money Laundering
Orlando, FL - United States Attorney Robert E. O'Neill announces that Joseph Wagner (62, Daytona Beach) today pleaded guilty to health care fraud, conspiracy to illegally distribute prescription drugs, and money laundering. Wagner faces a maximum penalty of 30 years in federal prison. He was indicted on June 13, 2012.
Alabama Board of Pharmacy Sterile Compounding Forms
Alabama Board of Pharmacy Requires the Following Forms With Regard to Sterile Compounding Pharmacies:
| USP/NF <797> RISK ASSESSMENT - Sterile Compounding Pharmacy |
USP<797>Pharmacist Sterile Compounding Statement (Notary requred)  PDF |
| USP <797> Risk Level Assessment Form PDF |
| USP <797> Compliance Self-Assessment Form PDF |
| USP <797> Action Plan, Exception & Compliance Form PDF |
Blue Cross Blue Shield Position in Tennessee on Reimbursement for Compounds
COMPOUND DRUG INFORMATION
Compound drugs, which require a prescription from a doctor, are prepared by a pharmacist who mixes or adjusts drug ingredients to customize a medication to meet a patient’s individual needs.
Differences Between Compound Drugs and Other Prescription Drugs
Compound drugs often have the same active ingredients as brand-name and generic prescription drugs but can differ from these medications in:
- strength – compound drugs can be prepared in strengths not usually available;
- inactive ingredients – compound drugs can be made without some of the dyes, sugars, preservatives and other inactive ingredients found in regular prescription drugs; or
- form – compound drugs can be prepared as lozenges or syrups instead of hard-to-swallow pills or in other forms that are not usually available..
Coverage for Compound Drugs
Check your Evidence of Coverage (EOC) or member handbook to see if your plan covers compound drugs.
Check your Evidence of Coverage (EOC) or member handbook to see if your plan covers compound drugs.
If compound drugs are covered by your plan, it’s important to remember that pharmacies that are in-network for regular prescription drugs may be out-of-network for compound drugs. Based on your pharmacy plan, you may not have to pay 100 percent of the drug’s cost if the pharmacy is in-network for compound drug prescriptions. Check your EOC or member handbook for more information on your plan's required copayment and/or deductible amounts.
You may have to pay more out of your pocket if you have a prescription for a compound drug filled at a pharmacy that is not in-network for compound drugs. Check your EOC or member handbook for more information on your plan's coverage for compound drugs purchased at a non-participating pharmacy.
If you have mail order benefits, you can obtain your compound drugs from the mail facility and have your mediations shipped directly to you.
Choosing a Compound Pharmacy
If you use compound drugs, make sure the pharmacy you use is in-network for filling compound drug prescriptions. You can do this three different ways:
- Call the pharmacy you use and ask if they are in-network for compound drugs.
- Use our “Find a Pharmacy” tool.
- Call the Member Service number on your ID card.
How to Use the Online “Find a Pharmacy” Tool to Find a Compound Pharmacy:
- Select your Pharmacy Network. It is listed on your BlueCross BlueShield of Tennessee ID card -- for example, RX01.
- Select the “Compound Pharmacy” option in the box underneath the Pharmacy Network field to make sure your search is for pharmacies in-network for compound drugs.
- You may also enter your favorite pharmacy’s name, your city, state, zip code or county to narrow your search.
- Click the “Search” button once you have selected or entered all the appropriate information.
Remember -- Pharmacies that are in-network for regular prescription drugs may be out-of-network for compound drugs. If you fill a prescription for a compound drug at a pharmacy that is not in-network for compound drugs, you may have to pay more out of your pocket for your medication.
Information is from here.
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