URGENT NOTICE!!!!

Word has been received that the USP panel has granted the appeal and will remand the BUD date issues in Chapters <795> and <797> to the Compounding Expert Committee for review and engagement with stakeholders. It's a big win for our APC members - and for all pharmacy compounders.
https://twitter.com/a4pcrx/status/1238146305014235136?s=20
https://a4pc.org/common/Uploaded%20files/Advocacy/2020-03-12%20795%20and%20797%20Appeal%20Response.pdf

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Pharmacy Guide to Compliance: An Overview of Three Federal Laws Central to Pharmacy Compliance

FDA (Drug Supply Chain Security Act-DSCSA)
DEA (Controlled Substance Act-CSA)
EPA (Resource Conservation and Recovery Act-RCRA)

Available at: https://info.pharmalogistics.com/pharmacy-compliance-hb-media

News

USAMMDA Announces Agreement with Gilead Sciences to Provide Remdesivir for Warfighters Exposed to Coronavirus Disease
The U.S. Army Medical Materiel Development Activity (USAMMDA) announced today it has entered into a Cooperative Research and Development Agreement with Gilead Sciences to provide Gilead's investigational drug, remdesivir, for the treatment of DOD personnel exposed to coronavirus disease. The USAMMDA Force Health Protection program will allow for the investigational use of remdesivir provided by Gilead, at no cost to the government, in the absence of any approved treatment options.

For a copy of the release, contact Carey.A.Phillips2.civ@mail.mil

Federal Agencies Crack Down on Fake Coronavirus Cures
The FDA and the FTC have sent warning letters to seven companies accused of selling unapproved products that claim to treat COVID-19. The companies advertise products such as teas, essential oils, and colloidal silver, claiming they can treat or prevent the coronavirus. "There already is a high level of anxiety over the potential spread of coronavirus. What we don't need in this situation are companies preying on consumers by promoting products with fraudulent prevention and treatment claims," said FTC Chairman Joe Simons. The letters tell the companies to immediately stop making claims their products can cure or treat the coronavirus and that if they do not, the FTC may go to federal court to stop the marketing and get money refunded to consumers. The recipients have to respond within 48 hours.
https://www.beckershospitalreview.com/pharmacy/federal-agencies-crack-down-on-fake-coronavirus-cures.html

FDA Advances Work Related to Cannabidiol Products with Focus on Protecting Public Health, Providing Market Clarity
Over the past year, the U.S. FDA has embarked on a comprehensive evaluation of cannabidiol (CBD) products, with a focus on educating the public about the risks and unknowns of these products, gathering the science needed to better understand both these safety concerns and potential benefits to inform our regulatory approach, as well as taking steps when necessary to address products that violate the law in ways that raise a variety of public-health concerns.

The FDA is now providing updates on efforts in this area, including several new steps in areas of education, research, and enforcement with the ultimate goal of continuing to protect the public health and working to provide market clarity.
https://www.fda.gov/news-events/press-announcements/fda-advances-work-related-cannabidiol-products-focus-protecting-public-health-providing-market

Indomethacin Suppositories Cost Skyrocketing
There is only one option in the U.S. for preventing acute pancreatitis as a complication of endoscopic retrograde cholangiopancreatography (ERCP) and that is rectally administered indomethacin. The price for a single dose has grown from about $2 to $340 over the past 15 years, with hospital upcharges potentially driving the cost exponentially higher. Also, since they are used off-label in this setting, patients may be required to pay the higher costs.
https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2762701

Did You Know ...

...that George Washington said the following?

"The turning points of lives are not the great moments. The real crises are often concealed in occurrences so trivial in appearance that they pass unobserved."

Tip of the Week

It's not necessarily the accolades one receives from doing a good job in view of the masses, but the daily routine of raising ones family, doing one's job, and handling the "crises" as they appear and confront them, overcome them, and grow in maturity.

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Looking Back

Just spread,
Then pat,
Now shave,
That's that!

Classified

ApotheCARE Pharmacy has an immediate opening for a Pharmacist in Elizabethtown, Kentucky

• Established Compounding Pharmacy
• State-of-the-art, 800 Compliant Compounding Lab
• Excellent benefits package plus bonus
• Ownership opportunity

Ideal candidates are proficient in BHRT, ZRT testing, topical pain, pediatric, and pet compounding. Please email resume to: sholdman@bbtel.com

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