Tuesday, April 26, 2016

Self-Assessment Forms - Use The 2014 Versions - CA St Board of Rx

The California Board of Pharmacy announced*:

"Board regulations (Title 16 California Code of Regulations sections 1715 and 1784), require that all licensed pharmacies and wholesalers complete a Self-Assessment by July 1 of every odd-numbered year.

The board recently updated the Self-Assessment forms through a formal rulemaking. The updated forms contain references to statutory and regulatory changes that occurred between 2011 and 2014 (inclusive).

While the rulemaking process was underway, the board accepted from pharmacies, hospital pharmacies and wholesalers completion of either the 2011 version OR the draft 2014 version: both versions have been available for use on the board’s website.

On April 20, 2016, the Office of Administrative Law approved the revised self-assessment forms. These forms can be downloaded at: http://www.pharmacy.ca.gov/licensees/facility/self_assess.shtml  They will all have “(Rev. 10/14)” date on them in in the lower left corner of the pages.

Form 17M-13: “Community Pharmacy Self-Assessment/Hospital Outpatient Pharmacy Self‐Assessment (Rev. 10/14)”
Form 17M-14: “Hospital Pharmacy Self‐Assessment (Rev. 10/14)”
Form 17M-26: Form 17M-26: “Wholesaler Dangerous Drugs & Devices Self-Assessment (Rev. 10/14).”

The board encourages all pharmacies, hospital pharmacies and wholesalers to complete the revised forms if they have not already completed the 2014 assessments. The board will no longer accept the 2011 versions of the self-assessment forms as [compliant]."

* Source:
California State Board of Pharmacy Subscriber Alert - emailed to PHARM-GENERAL@DCALISTS.CA.GOV on April 25, 2016.

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Friday, April 22, 2016

Lifeflo Inc Offers Emergency Supplemental Oxygen Over the Counter | HomeCare Magazine

Read the full article: Lifeflo Inc Offers Emergency Supplemental Oxygen Over the Counter | HomeCare Magazine:

"In the cash-only realm, the Lifeflo OTC Emergency Oxygen (lifeflooxygen.com) acts as a life-saving technology that DME providers can use to expand sales and connect to the community in a meaningful way. “We believe that carrying this technology gives HME providers an opportunity to market a simple and affordable technology,” says Normand. “DME providers can sell this product without a prescription from the physician. People were shocked by that.”"

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Thursday, April 21, 2016

Florida’s Adoption of Federal Exemptions for Wholesale Drug Distribution May Benefit Pharmacies, Practitioners and Hospitals | Akerman LLP - Health Law Rx - JDSupra

Read the full article: Florida’s Adoption of Federal Exemptions for Wholesale Drug Distribution May Benefit Pharmacies, Practitioners and Hospitals | Akerman LLP - Health Law Rx - JDSupra:

"The 2016 Florida Legislature enacted substantial legislation (Ch. 2016-212, Laws of Florida) to bring Florida’s Drug and Cosmetic Act (Ch. 499, Florida Statutes) in line with the federal Drug Supply Chain and Security Act (“DSCSA”). Since the DSCSA preempts state law, the changes were necessary to avoid confusion between the state and federal exemptions to the term “wholesale distribution”."

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Tuesday, April 19, 2016

HMDR Licensing - 30% Fee Increase

Go to the announcements on: HMDR Licensing Program Home Page:

"News, Hot Topics, & Updates:

HMDR License Fees (Effective July 1, 2016)"

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In a nutshell:
Effective July 1, 2016, the California Department of Public Health (CDPH), Food and Drug Branch (FDB) licensing fees will increase by 30 percent pursuant to the California Health and Safety (H&S) Code Sections 111630 and 111656.1 authorizing CDPH to establish and adjust licensing fees to cover the estimated program costs.

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Saturday, April 16, 2016

HME Audit Key data provides first look at severity of audits | HME News

Read the full article: Tool provides first look at severity of audits | HME News:

"Nationwide, 78% of providers appealed denials, with O&P leading the way with a 98% appeal rate, followed by ostomy, urological and wound care supplies at 87%.

Upon review, 60% of claims for hospital beds, support surfaces and manual wheelchairs were paid. For O&P and respiratory equipment, 15% and 74%, respectively were paid."

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Thursday, April 14, 2016

Bradenton man sentenced to prison for selling counterfeit, unapproved and misbranded drugs | Bradenton Herald

Read the full article: Bradenton man sentenced to prison for selling counterfeit, unapproved and misbranded drugs | Bradenton Herald:

"The U.S. Attorney's Office for the Middle District of Florida said Lohr generated more than $1 million in sales of these misbranded and counterfeit drugs. At no time was Lohr ever licensed as a pharmacist, a drug importer or a drug wholesaler, according to the release, and neither was American Drug Club a licensed pharmacy, drug importer or wholesaler."

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Monday, April 4, 2016

Brink’s Life Sciences transports delicate pharmaceuticals to patients worldwide | Miami Herald

Read the full article: Brink’s Life Sciences transports delicate pharmaceuticals to patients worldwide | Miami Herald:

"Seeing a major business opportunity for its existing international logistics and security network, Brink’s set up its Life Sciences Division and began rolling out its specialized services in North America and throughout the world. “Our focus on securing the supply chain for life sciences products is an area where we feel we have a competitive advantage,” Moreira said."

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