Thursday, December 5, 2013

CA Designated Representative License Application - CA Board of Pharmacy

Updated links: October 4, 2016

California Board of Pharmacy - Apply for a License: "Designated Representative (Exemptee)

Wholesale operations that distribute dangerous drugs or dangerous devices must be supervised by a registered pharmacist or an individual approved by the board as a designated representative. These companies may not operate unless the pharmacist or designated representative is physically on the licensed premises. To ensure proper control at all times, the board recommends that there be more than one person approved to supervise operations. The Designated Representative application forms may be obtained by download only."

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Wednesday, December 4, 2013

Full-line distributor sales topped $300 billion in 2012 - DQSA lot/item level tracking stats

Full-line distributor sales topped $300 billion in 2012, representing 91% of pharma sales - Pharmaceutical Commerce:

"The Factbook contains operational details often of high interest to vendors serving wholesalers’ infrastructure needs. One particular number to call out: two out of three HDMA members are already tracking lot-level barcodes through their systems for at least some of their products. Lot-level tracking is now the centerpiece of the Drug Quality and Security Act, which will mandate such tracking over the next four years. Data on item-level tracking (the next stage in DQSA) is occurring, but at significantly lower percentages."

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Monday, December 2, 2013

FDA Posts 3 New Draft Guidances RE: Human Drug Compounding

The FDA just published 3 new draft guidances related to compounding. 


In a nutshell, they cover: earlier guidance prohibitions; "outsourcing facilities" (OF) voluntary registration; and how OF's should report their compounded drugs.


Category Title Type Date
Procedural Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 107KB) Draft Guidance 12/02/13
Procedural Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 60KB) Draft Guidance 12/02/13
Procedural Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act (PDF - 91KB) Draft Guidance 12/02/13

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What To Do When Your Florida CDR Quits

What To Do When Your FL CDR Quits

Here's what the Florida Division of Drugs, Devices and Cosmetics says . . .

Program FAQ 6:   "DIVISION OF DRUGS, DEVICES AND COSMETICS

My company is a prescription drug wholesale distributor (in-state or out-of-state). Our Certified Designated Representative (CDR) just quit. What do we do?

Notify the department within 10 business days from the CDR’s separation. Your company may continue to distribute prescription drugs in or into Florida during that 10-business day-period. After that period expires, however, your company must either (a) engage a replacement CDR and notify the department of same or (b) cease prescription drug distributions in or into Florida.

The Department can, upon written request to appropriate personnel, provide a list of all unaffiliated CDR’s."

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Sunday, December 1, 2013

Certified Designated Representative (CDR) - FL DBPR DDC Program

Certified Designated Representative (CDR) - FL Dept of Business and Professional Regulation:  

"DIVISION OF DRUGS, DEVICES AND COSMETICS

CERTIFIED DESIGNATED REPRESENTATIVE

All prescription drug wholesale distributor and out-of-state prescription drug wholesale distributor permittees and applicants must designate in writing at least one natural person to serve as the designated representative for a given establishment. Such person must have an active certification from the department (a “certified designated representative” or “CDR”)."

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Thursday, November 28, 2013

Obama signs Drug Quality and Security Act into law - SecuringIndustry.com

SecuringIndustry.com - Obama signs Drug Quality and Security Act into law:

"President Obama has signed H.R. 3204 into law, setting the wheels in motion for the FDA to develop a national track-and-trace system to secure the pharmaceutical supply chain.

The aim of the Drug Quality and Security Act (DQSA) is to "minimise opportunities for contamination, adulteration, diversion, or counterfeiting," whilst also clarifying the FDA's authority to regulate compounding pharmacies, according to the White House."

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Monday, November 18, 2013

Breaking news: US Senate clears track-and-trace bill - SecuringIndustry.com

SecuringIndustry.com - Breaking news: US Senate clears track-and-trace bill:

"The US Senate passed H.R. 3204 by unanimous voice vote today, bringing a national track-and-trace system for medicines and new laws governing compounding pharmacies to the brink of fruition.

With the House having given its blessing to H.R. 3204- also known as the Drug Quality and Security Act (DQSA) - at the end of September, all that remains now is for the bill to be passed to President Obama for signature."

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HDMA’s 2013 Track-and-Trace Conference: Right Here Waiting for H.R. 3204 - FDA Law Blog

FDA Law Blog: HDMA’s 2013 Track-and-Trace Conference: Right Here Waiting for H.R. 3204:

"With fingers crossed, attendees looked ahead to the future of track-and-trace. Panelists expressed that the national system will hopefully make it harder for bad actors to corrupt the integrity of the supply chain, as the current patchwork of state pedigree laws allows bad actors to shop around for more lenient states. It is hoped that this bill will put everyone on a level playing field and reduce loopholes."

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All Eyes On The U.S. Senate Tonight - RxTrace

Hold your breath. Let's see if the U.S. Senate will pass this bill, H.R. 3204 (An act to amend the Federal Food, Drug, and Cosmetic Act with respect to human drug compounding and drug supply chain security, and for other purposes.)

All Eyes On The U.S. Senate Tonight - RxTrace:

"There are lots of things that would be triggered by passage of the law. No doubt, the most important one is that the California pedigree law would immediately become inoperative. That is, all of the “clocks” in that law—like January 1, 2015 for 50% of all drugs being serialized and pedigreed, etc.—would stop and disintegrate into irrelevance along with those of all other state pedigree laws."

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Friday, November 15, 2013

Florida Certified Designated Representative Exam - Locate a Pearson Vue Test Center

Florida Certified Designated Representative candidates must take an examination that's administered at a Pearson Vue Test Center.

Here's how to find a Pearson Vue Test Center near you:
  1. Follow the "Locate a Test Center" link below
  2. Choose category. Click on "Government / State Regulated / Federal Government"
  3. Choose testing program. Click on "Florida Certified Designated Representative - Drugs, Devices and Cosmetics"
  4. Test Center Search. Enter your search information to run a search
Locate a Test Center: Locate a Test Center

"Pearson VUE delivers certification and licensure tests through the world’s largest network of test centers in 175 countries across the world."

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Monday, November 11, 2013

Fingerprint Card Request - CA Board of Pharmacy

The CA Designated Representative application process includes fingerprint requirements. The Board will only accept fingerprint cards from residents outside of California (... in contrast, the board will only accept Live Scan Service Forms from California residents. Live Scan will be accepted from residents of other states if the Live Scan service is performed in California.).

Follow the link below to request fingerprint cards from the California Board of Pharmacy . . .

Publications, Brochures and Fingerprint Card Request - Pharmacy Board:

"To request publications, brochures and fingerprint cards, please select the desired forms and complete your name and address. When the information is complete, please click on the submit button"

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Saturday, November 9, 2013

End game for US medicines traceability bill? - SecuringIndustry.com

Updated Oct 28, 2015:  It passed, and is now enacted. Here's the full text:
Text of the Drug Quality and Security Act (govtrack.us)

= = = original post follows = = =

Prospects for the Drug Quality and Security Act (H.R. 3204) are not so promising . . .

SecuringIndustry.com - End game for US medicines traceability bill?:

"Govtrack.us is currently putting the chances of the bill being enacted at 42 per cent. The Congressional Budget Office (CBO) estimates that H.R. 3204 will authorise the collection of $27m in user fees for fiscal years 2014-2018."

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Thursday, November 7, 2013

Vitter’s Demands Hold Up Compounding-Pharmacy Bill - Bloomberg

Vitter’s Demands Hold Up Compounding-Pharmacy Bill - Bloomberg:

"One lawmaker’s effort to alter Obamacare is holding up final action by Congress on legislation that would expand U.S. regulation of compounding pharmacies linked to meningitis deaths last year.

The Senate is poised to approve the measure to broaden the U.S. Food and Drug Administration’s oversight of compounding pharmacies. Ninety-nine senators have agreed to pass the legislation that the House passed without a roll call vote, Democratic and Republican lawmakers said.

Republican Senator David Vitter of Louisiana wants the vote on compounding pharmacies coupled with consideration of his proposal to deny lawmakers and their staffs employer contributions when they buy medical insurance on the exchanges set up under the new health-care law. As a result, senators may have to spend a week on work that could be done in minutes."

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Drug Supplier Will Acquire Pharmaceutical Wholesaler - CEMag

Drug Supplier Will Acquire Pharmaceutical Wholesaler - CEMag:

"ScripsAmerica Inc. has signed an agreement to acquire PIMD International, LLC, a wholesale distributor of prescription drugs as well as medical supplies and devices.

Based in Miami, PIMD International LLC serves as a pharmaceutical wholesaler to pharmacies, hospitals, and physician's offices in the US. The company also sells medical supplies in all health care settings and online. PIMD, which will become part of ScripsAmerica, provides its customers with access to specific medications for their end users."

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Thursday, October 31, 2013

Rotech Creating 200 Jobs in Charlotte NC

PRESS RELEASE: Rotech Healthcare Inc. Creating 200 Jobs in Charlotte | NREIWire content from National Real Estate Investor:

"The company has already started hiring and will continue to do so until all jobs are filled, posting opportunities in the careers section at rotech.com. Positions include customer support managers, customer support supervisors, patient account specialists and customer support specialists."

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Cardinal Health and FedEx will provide combined 3PL services

Strategic alliance between Cardinal Health and FedEx will provide combined 3PL services - PharmaceuticalCommerce.com:

"Noting that the two companies have been working together for over 10 years to provide 3PL services to healthcare products companies, the two will now offer combined global transportation, warehousing and distribution services. FedEx brings, among other things, the No. 1 air cargo airline; Cardinal brings its 40 distribution centers, and expertise in managing healthcare products shipping."

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Wednesday, October 9, 2013

Drug Supply Chain at Risk for Diversion & Counterfeit

Prescription Drug Supply Chain at Risk for Diversion Schemes and Counterfeit... -- MOUNT PROSPECT, Ill., Oct. 9, 2013 /PRNewswire-USNewswire/ --:

"In "Wholesale Drug Distribution: Protecting the Integrity of the Nation's Prescription Drug Supply," NABP points to the roles of unscrupulous wholesalers in distributing counterfeit drugs and unapproved foreign-sourced drugs that have endangered patients across the country. To help safeguard the distribution chain, NABP has implemented updated criteria for the Association's Verified-Accredited Wholesale Distributors (VAWD) accreditation program"

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New CA Law - SB 294 Requires A Special License For Sterile Compounders

Governor Jerry Brown signed Senate Bill 294 into law. SB 294 will go into effect in July of 2014.

Highland News > Archives > News > Bill Increasing Oversight Of Sterile Compounding Pharmacies Signed Into Law:

"Specifically, SB 294 requires both in-state and out-of-state pharmacies that compound sterile drug products for California patients that will be inhaled, injected, or administered into the eye to apply for a special, additional license from the California State Board of Pharmacy. Under this new law, the board is required to inspect these facilities annually to provide consistent oversight and ensure compliance with pharmacy law."

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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

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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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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Saturday, August 31, 2013

Shrinking - Insurance Coverage Of Some Compounded Meds

It appears that health insurers are getting concerned about the safety and quality of compounded meds.

Compounding Problems: Anthem Restricts Coverage Of Some Compounded Meds | Pharmalot:

"More fallout from the compounding controversy. Anthem Blue Cross Blue Shield, one of the nation's largest insurers, has decided to end reimbursement of certain compounded medications as of November 1. Specifically, the insurer will not pay for compounded bulk powders or pharmaceutical adjuvants that are not approved by the FDA, according to a mailing that were sent to pharmacists."

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Saturday, August 17, 2013

CA Board of Pharmacy - It's Time to Complete Self-Assessments - Download Forms

Updated April 26, 2016:

Use the latest version of the forms posted on the Board's website:

CA Board of Pharmacy - Self-Assessment Forms

---  The post below is outdated --- 

The Board just sent out an email announcement informing California hospital pharmacies, hospital outpatient pharmacies, community pharmacies, compounding pharmacies, and wholesalers that they should now complete their self-assessments.  The Board expects that all self-assessments be completed in the next 30 days.

CA Board of Pharmacy - Applications and Forms:

" *Earlier this year, the board submitted to the Office of Administrative Law revised self-assessment forms that incorporated statutory and regulatory updates since 2011. This rulemaking was withdrawn from OAL, and a formal rulemaking will be initiated later this year. However, the revised (2013) forms MAY be used by a pharmacist or designated representative in charge if desired.

Current regulations require that the version(s) last approved by OAL be completed; however, the board will accept completion of either the OAL-approved versions OR the versions that were revised in 2013 (which will be the subject of a future formal rulemaking)."

Follow this link to find and download the Self-Assessment Forms
(Tip: You'll need to scroll down the page to these forms)

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Tuesday, August 13, 2013

Renew Your License Early - Avoid New Computer System Disruptions - CA Board of Pharmacy

August 30, 2013 Update:

I just ran across the following updated information on the Board's website, "Does your license expire September 30, October 1, October 31, or November 1? . . . If your license renewal date falls between September 30 to November 1 (inclusive), these cashiering disruptions could affect you."

- - -

California Board of Pharmacy:

"Does your license expire August 31, September 1, September 30 or October 1?

If so, please note:

The Department of Consumer Affairs is beginning its transition to a new computer system. Phase 1 implementation begins for certain departmental agencies in mid-September 2013. During this transition, there will be temporary disruptions in cashiering and other services affecting all Department of Consumer Affairs agencies, including the Board of Pharmacy. These disruptions will prevent the update of licensing records available online. (The Board of Pharmacy will transfer to the new system in phase 2.)

If your license renewal date falls between August 31 to October 1 (inclusive), these cashiering disruptions could affect you.

Please renew your license early! Do not wait and risk delayed renewal of your license!"

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Saturday, August 3, 2013

Senate In Recess - Didn't Vote On Track-and-Trace, Compounding Bill

Senate puts off vote for track-and-trace, compounding bill | Drug Store News:

"The Senate was expected to take up a bill designed to secure the drug supply chain and establish a list of "do not compound" medications, but left for recess Friday without voting on it.

The bill, S. 959, the Pharmaceutical Quality, Security and Accountability Act, had received some support from groups like the National Community Pharmacists Association, which supported the bill's goal of enhancing security, but expressed reservations about the compounding provision."

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Friday, August 2, 2013

Thursday, August 1, 2013

Pharmacy Diversion Awareness Conferences by the DEA

The California Board of Pharmacy, in a recent e-mail says,

"Prescription drug abuse is at an all-time high in this country. Drug diversion continues to be a principal cause of discipline for regulators of pharmacies, pharmacists and wholesalers. The federal Drug Enforcement Administration are conducting regional one-day conferences on these topics. The board will award six hours of continuing education credit to pharmacists and pharmacy technicians who attend a full session.

There will be meetings located in San Jose on August 18 and 19 and San Diego on August 16 and 17."

Follow this link to the DEA webpage for Pharmacy Diversion Awareness Conference dates, locations, general information, and registration

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