 |
,
We're in a heat wave and approaching the dog days of August, but here at Gates Healthcare this summer we are trying to stay cool and focused on our everyday mission of providing optimal service and sound advice to help our clients succeed.
In today's edition of
Out of the Gates we have more news to share, including the addition of two Associates who will further enhance our expertise in pharmacy, and we also offer our take on an impending change in inspection procedures by federal regulators. Please read on for more details.
Best wishes.
Sincerely,
Ernest P. Gates Jr., RPh, FASCP, FIACP, FACA
President,
Gates Healthcare Associates
|
|
|
|
Our View on FDA's Revised Procedure
for Compounding Pharmacy Inspections
New procedures for FDA inspections of compounding pharmacies are around the corner.
Effective Aug. 1, according to a
notice published on the Food and Drug Administration's website, inspectors will first assess whether a pharmacy is in compliance with "503A" requirements before applying "503B" standards to their subsequent investigation and Form 483 observations.
The FDA stated that an investigator "
will not include observations that represent deviations solely from FDA's current good manufacturing practice (CGMP) requirements unless it appears, based on the investigator's preliminary assessment, that the firm compounds drugs that do not qualify for the exemptions under section 503A."
On the one hand, this is good news for traditional (503A) compounders, many of which have been subjected to the much more stringent CGMP standards required of high-volume, sterile compounders (503B outsourcing facilities). On the other, it is important to recognize that the FDA did not identify its specific criteria for determining whether a compounder is operating under 503A or 503B requirements.
In fact, it is not uncommon for a compounder to operate under the impression that it is functioning as a 503A organization, only to find out during an assessment by our consultants that some of its operations and procedures could be interpreted as subject to 503B requirements. For example, the presence of a prescription with each order in itself does not ensure a compliant 503A pharmacy.
This gray area, lingering despite the FDA's change in inspectional procedures, could result in serious regulatory consequences. That's why we encourage compounders to take notice of this FDA notice and to seek third-party assessments of their risks.
|
|
|
|
|
Two Associates Added to Gates Team
|
|
|
Verne Betlach |
Gates Healthcare has expanded its team and expertise with the addition of two new Associates.
Verne Betlach, RPh, FIACP has over 25 years of experience as a compounding pharmacist and recently served as a consultant with the Professional Compounding Centers of America (PCCA). He previously owned and operated his own compounding pharmacy in Minnesota, and he is an experienced trainer who was named a Fellow of the International Academy of Compounding Pharmacists.
|
|
|
John Consoletti |
John M. Consoletti, RPh has extensive experience as a sales and operations executive in the pharmacy and healthcare markets. He previously led the Massachusetts branch of a national home infusion and specialty pharmaceutical distributor, and has advised clients on sales, staff training and business development as a trusted healthcare consultant.
To read their full bios, please visit the
Team page on the Gates Healthcare website.
|
|
A Word From Our Partner, Kunesa
Recently, a global pharmaceutical player closed two of its compounding centers in the United States, largely due to reduced profitability as a result of the shifting reimbursement system. This defensive move serves as a wake-up call for compounding pharmacies to open up additional sources of revenue if they want to prosper despite a trend toward reduced margins and tougher competition.
As pharmacies in Europe learned decades ago, the best way to accomplish this is by increasing sales of front-end health and wellness items and services. To succeed here, U.S. pharmacies will have to move from a business model focused on filling a maximum number of prescriptions to one where Rx traffic is leveraged into higher sales of complementary OTC products and services.
Margins here are not controlled by anyone, and revenues depend exclusively on how well the product mix targets customer wants and needs, how professionally the customer is consulted, and how attractive the items are displayed. Even the most desirable high-margin cosmeceutical and nutritional brands are willing to partner with an independent pharmacy -- provided it offers an upscale, state-of-the-art look that corresponds to the exclusive image the brand aims to project.
Kunesa LLC -- a world leader in pharmacy design and Gates Healthcare strategic partner -- offers customized architectural solutions that allow pharmacies to differentiate from competitors and attract revenue-critical customers (such as women aged 30 to 70 with better education and higher income) in their markets. All of our 85-plus U.S. clients were able to significantly expand their sales of high-margin front end items, often by more than 100 percent in less than 12 months.
|
|
|
|
|
Healthy Headlines .....................................................
|
|
Gates Healthcare Associates
is a pharmaceutical and healthcare consulting firm that provides extensive clinical, programmatic, and regulatory knowledge and insight to an array of organizations nationally and abroad. We help our clients confront and overcome challenges and obstacles to growth, positioning them for long-term business success.
Copyright © 2016. All Rights Reserved.
|
|
|
|
|
|
