Thursday, November 22, 2018

Industry Calls for Changes to FDA’s DSCSA Product Identifier Guidance - RAPS.org

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Read the full article:  Industry Calls for Changes to FDA’s DSCSA Product Identifier Guidance - RAPS.org

"The biggest change industry is calling for is for FDA to allow manufacturers to use the GS1 Global Trade Identification Number (GTIN), which typically contains the National Drug Code (NDC) number along with other information, in the human-readable portion of the product identifier in place of the NDC. This request is echoed by the Biotechnology Innovation Organization (BIO), the Association for Accessible Medicines, the Healthcare Distribution Alliance, Bristol-Myers Squibb, Shire and GS1 itself.

In its comments, the BIO also asks FDA to revise the guidance to allow manufacturers more flexibility when it comes to ordering the human-readable portion of the product identifier."

You might also be interested in:
ICYMI: FDA Released Three DSCSA-Related Guidances - Healthcare Packaging

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California Designated Representative Training Courses (wholesaler, 3PL, reverse distributor) - Approved by the California State Board of Pharmacy
California Designated Representative Training Courses (wholesaler, 3PL, reverse distributor) - Approved by the California State Board of Pharmacy

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

Wednesday, November 21, 2018

Nonresident medical device sellers operating in CA may face fines with few options for compliance - DOTmed

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Read the full editorial by Robert J. Kerwin:  Nonresident medical device sellers operating in CA may face fines with few options for compliance - DOTmed


"In California, the Board of Pharmacy, which regulates matters pertaining to wholesaling of medical devices, is requiring sellers of medical devices who do not reside in California (“nonresident wholesalers”) to have a wholesalers’ license from their home state or else be subjected to a fine for conducting business in California without an appropriate license. This, despite the fact that many states do not issue medical device wholesalers’ licenses." 


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Designated Representative Training Courses - wholesalers, 3PL, reverse distributors (California & Florida)
Designated Representative Training Courses - wholesalers, 3PL, reverse distributors (California & Florida)


For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

You Snooze, You Lose: How Insurers Dodge The Costs Of Popular Sleep Apnea Devices - NPR

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Read the full article:   You Snooze, You Lose: How Insurers Dodge The Costs Of Popular Sleep Apnea Devices - NPR

"Medicare, the government insurance program for seniors and the disabled, began requiring CPAP "compliance" after a boom in demand. Between 2001 and 2009, Medicare payments for individual sleep studies almost quadrupled to $235 million. Many of those studies led to a CPAP prescription. Under Medicare rules, patients must use the CPAP for four hours a night for at least 70 percent of the nights in any 30-day period within three months of getting the device. Medicare requires doctors to document the adherence and effectiveness of the therapy."

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

Saturday, November 17, 2018

Survey: Turnover on the rise among hourly workers - Drug Store News

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Read the full article:

Survey: Turnover on the rise among hourly workers - Drug Store News

Key excerpts from the article: 
Respondents cited “better opportunities/promotions” as the No. 1 reason for departures in the retail industry, followed by more money and a desire for a more hours. When asked what retailers will be looking to do to curb turnover moving forward, “training” and “career pathing” were cited as the top focus areas, followed by “better communications on the employee value proposition” and “changes to compensation packages.”  
“To retain top employees, employers need to lay out clear career paths, offer training and pay competitive wages. It’s critical that employees feel nurtured and that they feel part of the organization instead of just having a job.”

Maintaining business continuity and regulatory compliance are top priorities in the HMDR niche. It's wise to consider the items mentioned in the article above.

Additionally, it's not unusual for some businesses to manage with just one HMDR Exemptee, or keep the bare minimum of licensed HMDR Exemptees on staff.  However, these companies can run into a situation that can affect the company's business financial health. In the event the company loses a licensed Exemptee (for example, the Exemptee quits and cross-coverage by another licensed Exemptee isn't possible), then the business operation could get into trouble with regulatory agencies, or just as bad, must suspend operation (until a licensed Exemptee can be on premise).

It's a difficult scenario, to be left scrambling, trying to find, hire, and get a new employee properly licensed as an Exemptee.  Therefore, consider the risks, and keep just the "right" number of licensed HMDR Exemptees.

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California HMDR Exemptee Training Certification Course for Home Medical Device Retailers (accepted by the California Department of Public Health - Food and Drug Branch)
California HMDR Exemptee Training Certification Course for Home Medical Device Retailers (accepted by the California Department of Public Health - Food and Drug Branch)


For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

Tuesday, November 13, 2018

Who Can You Call? - Ask A Board Inspector

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Read the full notice:  Got a question? Ask an Inspector - California Board of Pharmacy

"The board can be contacted via email, fax or telephone with questions pertaining to pharmacy law and regulations. On Tuesdays and Thursdays, a board inspector will be available to answer telephone inquiries. 
Note: The board’s inspectors and staff cannot provide you with legal advice, but they will assist you by identifying any statutory or regulatory sections that may pertain to your questions. Should you need legal advice, you are advised to contact a lawyer."

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Designated Representative Training Courses - California and Florida
Designated Representative Training Courses - California (wholesaler, 3PL, reverse distributor) - Florida CDR Exam Prep Course


For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

Friday, November 9, 2018

AmerisourceBergen's compounding site still on ice despite beefed-up oversight - BioPharma Dive

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Read the full article:

AmerisourceBergen's compounding site still on ice despite beefed-up oversight - BioPharma Dive

"PharMEDium, a drug compounder and subsidiary of AmerisourceBergen, received a series of Form 483s over the last year as regulators observed issues at several of its manufacturing plants. Some of the more common issues included failing to have procedures that adequately protect against contamination or ensure quality control."

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Root Cause Analysis and Deviation Investigation Report Writing - An online self-study FDA cGMP training
Root Cause Analysis and Deviation Investigation Report Writing - An online self-study FDA cGMP training course


For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

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