ALL-NEW Out of the Gates e-newsletter

Insights and updates from Gates Healthcare Associates

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OUT OF THE GATES

You look different somehow. Did you do something with your hair? New suit?

No, that's not it. Today we are delivering our e-newsletter with a whole new look. Out of the Gates offers a regular monthly dose of insights and updates from the Gates Healthcare team. The refreshed layout is much more mobile friendly, as we all know how often we check emails on our smartphones while multitasking through busy days.

We appreciate you opening up our newsletter. Feel free to give us your feedback. And please scroll down for more!

Sincerely,

Ernest P. Gates Jr., RPh, FASCP, FIACP, FACA

President, Gates Healthcare Associates

Take Control of Controlled Substances

The FDA has been ramping up inspections of compounding pharmacies in recent months as new regulations from the Drug Quality and Security Act are rolled out nationwide.

Meanwhile, another federal agency known by its three-letter acronym, the DEA, has its own part to play in keeping pharmacists up at night. Gates Healthcare has an entire team of experts, led by Vice President of DEA and Regulatory Compliance Jack Crowley, dedicated to keeping clients on the right side of DEA policies, procedures, and best practices. This is a critical regulatory area in which compliance professionals can provide support to a variety of healthcare organizations in pharmacy and hospital settings.

Gates Healthcare's goal is to help our clients take control of their controlled substance compliance and, in case of any DEA-related incident, help them navigate their way to a successful outcome.

Please click here for more about our DEA Regulatory Compliance Services.

Patrice Shook

Shook Joins Leadership Academy

Patrice Shook, an Associate with Gates Healthcare, has been accepted into the Leadership Academy of the Michigan Pharmacy Foundation, part of the Michigan Pharmacists Association.

In the year-long program, Shook will enhance her leadership and professional skills, strengthen relationships and interdisciplinary networks, and help advance the pharmacy profession.

An experienced compliance officer, Shook advises Gates Healthcare clients on compliance and quality programs for compounding pharmacies seeking accreditation status.

Connect with our expert consultants!

Neil A. Petry

Petry Elected to SNMMI Board

Neil A. Petry, MS, RPh, BCNP, FAPhA, has been elected director-at-large of the Society of Nuclear Medicine and Molecular Imaging.

Petry, a Senior Associate with Gates Healthcare, is associate professor of radiology and medical physics graduate program faculty member at the Duke University Medical Center in Durham, N.C. He has been an SNMMI member for more than 35 years.

With Gates Healthcare, Petry focuses on USP Chapter <797> sterile compounding guidelines on nuclear pharmacy and nuclear pharmacy medicine practice.

Healthy Headlines

The Republican newspaper in Springfield, Mass., recently published a story on its MassLive news site about how patients have a harder time getting insurance coverage for their compounded medicines, part of the continued fallout from the New England Compounding Center tragedy. The article quotes Ernie Gates and other industry experts about insurers' cost-control efforts.

CLICK HERE TO READ THE ARTICLE

Gates Healthcare also was featured in the latest edition of Compounding Matters Quarterly, an IACP publication. The article covers how Ernie Gates and Senior Associate Bill Mixon work with compounding pharmacies to help them see the benefits of a partnership with Lumara Health, a division of AMAG Pharmaceuticals, to dispense FDA-approved Makena, rather than the compounded version of the drug.

It's worth noting that the same edition of CM Quarterly includes a helpful article from LicenseLogix -- a partner of Gates Healthcare -- focused on licensing requirements for compounding pharmacies.

CLICK HERE TO READ THE ARTICLES

Below is additional news on compounding and other pharmacy-related topics. Click on the headlines for more:

FDA Issues Guidance on Adverse Event Reporting for Outsourcing Facilities

JAMA Study: Prescription Opioid Misuse and Deaths Increase

FDA Director Explains Plan to Reduce Drug Shortages

PharMEDium a Hit as Investors Renew Interest in Compounding Pharmacy Sector

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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.

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