Friday, September 27, 2013

Congress Clarifies Drug Compounding, Tracking Policies

Congress Clarifies Drug Compounding, Tracking Policies:

"After months of public hearings and negotiations, Democrat and Republican leaders of the House Energy & Commerce Committee and the Senate Health, Education, Labor and Pensions Committee unveiled a compromise bill last week. No one gets all they wanted from H.R. 3204, the Drug Quality and Security Act, but it provides more clarity and predictability to drug oversight programs and moves forward initiatives designed to enhance the safety and quality of medicines in the US."

Follow this link to the draft bill, Drug Quality and Security Act (PDF)

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Thursday, September 26, 2013

US Senate & House - Drug Quality and Security Act

This is promising news, cooperation and agreement between the House and Senate (and across the aisle), to converge on what could likely become final legislation. Stay tuned!

US Senate Committee on Health, Education, Labor, & Pensions: Newsroom - Press Releases:

" “This legislation will improve the safety of compounded drugs by clarifying the oversight responsibilities of the FDA over large-volume compounders and by holding facilities to high quality standards. This bill also calls for an unprecedented tracing system that will track prescription drugs from manufacturing to distribution. I commend the bipartisan spirit that brought this compromise proposal together.” "

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Thursday, September 19, 2013

CA To Amend Track-and-Trace Law re: ‘Drop Shipments’

California to amend track-and-trace law to deal with ‘drop shipments’:

"The proposal specifies that in the case of a drop shipment, the manufacturer would “omit data elements from the pedigree showing transfers of ownership to and from the wholesale distributor, including any certifications of receipt and delivery of the drug by the wholesaler.”

The electronic pedigree, however, would need to be “conveyed directly from the manufacturer to the authorized purchaser prior to or contemporaneously with the delivery” of the drug, according to the board."

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Alert - Individuals Posing as Delivery Driver or Cardinal Health Employees - CSHP

Alert - Individuals Posing as Delivery Driver or Cardinal Health Employees - California Society of Health-System Pharmacists:

"In recent days, Cardinal Health has been notified by a number of customers in the Los Angeles area that an individual has presented himself as a Cardinal Health employee. The individual has attempted to enter pharmacies by announcing that a new Cardinal Health policy has been put in place that will provide our customers a refrigerator for the storage of cold chain packaging that needs to be returned. On one known occasion, the individual was allowed into the controlled area of a pharmacy to study a possible location for the refrigerator."

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Monday, September 16, 2013

House Version of Compounding Legislation Emerges, Contrasts With Senate Approach

House Version of Compounding Legislation Emerges, Contrasting Sharply With Senate Approach:

"Now legislators will be tasked with negotiating out differences in their legislative approaches. The PQSA is significantly more rigorous toward the compounding industry than the Compounding Clarity Act, and also includes track and trace legislative measures. The significant differences and approaches between the two pieces of legislation mean it could be months before any legislation stands a chance of reaching President Barack Obama's desk."

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Friday, September 13, 2013

On-Line Change of Address Form - CA Board of Pharmacy

The following link will take you to a webpage that gives an overview of the California laws and regulations governing Board of Pharmacy address change reporting requirements:

Board of Pharmacy - Technical Help:

"You are required to notify the board of any change in your address within 30 days. Change of address may be made on-line or in writing to the board."

If you are a licensed California Designated Representative, or other affected party, follow this link to the California Board of Pharmacy - On-line Change of Address Form.

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Wednesday, September 11, 2013

Former Owner of LA Medical Equipment Supply Co Pleads Guilty to $2.6 Million Medicare Fraud

Former Owner of Los Angeles Medical Equipment Supply Company Pleads Guilty to $2.6 Million Medicare Fraud Scheme:

"From approximately June 7, 2006, through Sept. 28, 2009, Afolabi, through Emmanuel, submitted approximately $2,668,384 in fraudulent claims to Medicare for power wheelchairs and related services, and Medicare paid Emmanuel approximately $1,490,532 on those claims."

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Business Owners May Face $100-Per-Day Penalty Under ObamaCare | Fox

Business Owners May Face $100-Per-Day Penalty Under ObamaCare | Fox Small Business Center:

"Small business owners who thought they were off the hook for ObamaCare regulations until 2015 may be in for an expensive wake-up call next month.

Beginning Oct. 1, any business with at least one employee and $500,000 in annual revenue must notify all employees by letter about the Affordable Care Act’s health-care exchanges, or face up to a $100-per-day fine."

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Tuesday, September 3, 2013

Drug Channels: 12 Fastest-Growing, Private Specialty Pharmacies

Drug Channels: Say Hello to the 12 Fastest-Growing, Private Specialty Pharmacies:

"The 2013 Inc. 500 list, which is based on 2012 revenues, includes 12 specialty pharmacies. The pharmacies and their key stats are listed below, along with recent specialty forecasts. Diplomat Pharmacy again topped the specialty pharmacy list, with revenues of $1.1 billion, up 42% vs. 2011. The other 11 pharmacies had total revenues of $1.3 billion.

Pay attention: these companies are the vanguard of tomorrow’s pharmacy industry."

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