Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

News

White House Moves to Tighten Control Over Federal Regulators
The White House on Thursday moved to curb the power of federal regulators by directing them to submit nonbinding guidance documents to the budget office for review, a step that could slow down the enactment of any rule with a potentially large impact on the economy.
https://www.politico.com/story/2019/04/11/white-house-federal-regulators-1347496

FDA Requires Some Over-the-counter Sanitizers to Use New Drug Approval Pathway
The FDA issued a final rule requiring OTC sanitizers with certain active ingredients to seek approval under an NDA or ANDA as a new drug. The agency “aims to help provide consumers with confidence that the OTC hand sanitizers they’re using are safe and effective when they don’t have access to water to wash with soap,� said CDER Director Janet Woodcock.

The FDA has deemed 28 active ingredients, including benzethonium chloride, ineligible for OTC drug-review evaluation. Three active ingredients will still be evaluated under OTC drug review: 1) ethyl alcohol (60% to 95%), 2) isopropyl alcohol (70% to 91.3%), and 3) benzalkonium chloride. The agency omitted the three ingredients from the final rulemaking to allow more time to collect safety and effectiveness data.
https://www.fdanews.com/articles/190992-fda-requires-some-otc-sanitizers-to-use-new-drug-approval-pathway

Medication Adherence Suffers When Pharmacies Close
A nationwide, claims-based study found that pharmacy closures had a negative impact on medication adherence among those who had been taking their cardiovascular drugs regularly; patients are more likely to completely stop statins, beta-blockers, and oral anticoagulant therapy.

When people had their statin prescription filled at a pharmacy that subsequently shut down, their mean statin adherence rates dropped 6 percentage points over the following 3 months, and the difference persisted over 12 months of follow-up, reported Dima Qato, PharmD, MPH, PhD, of the University of Illinois at Chicago, and colleagues in JAMA Network Open.

"Declines in adherence were most pronounced among older adults using independent pharmacies, purchasing from a single store to fill all their prescriptions, or living in low-access neighborhoods with fewer pharmacies and were consistent across several classes of cardiovascular medications," they said.
https://www.medpagetoday.com/cardiology/prevention/79324

Did You Know ...

…that Thomas Jefferson said the following?

“A government big enough to give you everything you want, is strong enough to take everything you have.�

Tip of the Week

When will it all stop? I’m referring to all the government handouts that we “deserve�! When did freebies, including cell phones, medical care, education, child-care, free meals, bulk food, housing, entertainment, etc. all become “rights� because we “deserve� them and are paid for by the government (US!)? There is nothing anyone has done to “deserve� them outside of working or serving to earn them. Who is going to pay for all the “freebies�? Is it really good for the government to “control� one’s life? Where is the money coming from to pay for these “rights�? Taxes? Who pays the taxes?

With some complaining that the rich don’t pay their fair share, look at the posted IRS statistics:

     The top 1% of earners pay 37.3% of all the income taxes.

     The top 20% of earners pay 87% of all the income taxes.

     The top 50% paid 97% of all the income taxes.

     39% pay NO TAXES!

Just a note, the income level for the:

• top 1% of U.S. earners is $422,000 or more per year, and the
• top 20% earned over $100,000 per year.

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Looking Back

Whiskers,
Easy come you know,
Why not make them,
Easy go?
     Burma-Shave