Don’t get caught without a California Pharmacy Wholesaler License | Wit of Mandate | Official Blog of Simas & Associates, Ltd. | California's Leading Professional License Defense Law Firm:
"Such a wholesaler must not only apply for a corporate or company license, but must also license each separate place of business operated, and designate a representative who is responsible for compliance with the state and federal laws regarding wholesalers (Business & Professions Code Section 4161(b))."
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Monday, September 30, 2013
Friday, September 27, 2013
Congress Clarifies Drug Compounding, Tracking Policies
Updated 12/12/2022
The links in the original post broke.
You might also be interested in:
--- the original link follows below ---
"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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- - -
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California (earn a training affidavit):- CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
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Thursday, September 26, 2013
US Senate & House - Drug Quality and Security Act
Updated May 3, 2023
You might also be interested in:
--- the original post follows below ---
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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- - -
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California (earn a training affidavit):- CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
- CA Designated Representative 3PL Training
- CA Designated Representative Reverse Distributor Training
- The Designated Representative Institute
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Wednesday, September 25, 2013
Survey Finds S.B. 959 Would Require 4 in 10 Compounding Pharmacies Surveyed to Abandon the Pharmacy Profession
"A recent poll of independent compounding pharmacies by PCCA shows that 4 in 10 of the pharmacies surveyed would be required to abandon the pharmacy profession under the terms of Senate Bill 959, The Pharmaceutical Quality, Security, and Accountability Act."
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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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"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
Updated March 2, 2022
Unfortunately, the linked alert is no longer available.
--- the original post follows below ---
"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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- The Designated Representative Institute
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Monday, September 16, 2013
House Version of Compounding Legislation Emerges, Contrasts 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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California (earn a training affidavit):- CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
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Saturday, September 14, 2013
The US House Finally Introduces A Compounding Pharmacy Bill | Pharmalot
The US House Finally Introduces A Compounding Pharmacy Bill | Pharmalot:
"A long-awaited compounding pharmacy bill from the US House of Representatives has finally been introduced and, like a Senate bill introduced earlier this year, offers greater authority to the FDA. But while a key organization representing pharmacists is backing the effort, consumer advocacy groups remain concerned that both bills create loopholes that may create dangers for patients."
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"A long-awaited compounding pharmacy bill from the US House of Representatives has finally been introduced and, like a Senate bill introduced earlier this year, offers greater authority to the FDA. But while a key organization representing pharmacists is backing the effort, consumer advocacy groups remain concerned that both bills create loopholes that may create dangers for patients."
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Friday, September 13, 2013
On-Line Change of Address Form - CA Board of Pharmacy
Change of Address Form (online) - California 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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"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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"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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"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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