Sunday, January 27, 2013

Pharmacy Wholesaler H.D. Smith Expands

The company is the 4th-largest pharmaceutical wholesaler in the nation, and the largest that is privately owned.

H.D. Smith continues to grow - Springfield, IL - The State Journal-Register:

"The company expanded into the northern California and the Northwest through the November buyout of Valley Wholesale Drugs. Valley Wholesale served more than 600 independent pharmacies in California and Nevada. The deal included a distribution license for Washington State.

Expansion into retail pharmacy markets also has meant the addition of regional distribution centers for H.D. Smith, including now in Illinois, California, Texas, New Hampshire, New Jersey, Florida and Kentucky."

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Thursday, January 24, 2013

Dirk Rodgers on Inference

Another excellent article by Dirk Rodgers and touchpoints with California law.  The following snippet just happened to catch my eye.

How Should Inference Work?:

" . . . Companies will need to create and document their Standard Operating Procedures (SOPs) for making use of the container serial number hierarchy when they infer the contents in each business process.  According to the law, this will need to include some kind of statistical sampling process for determining the accuracy of the aggregation information provided to them.  The SOPs will need to be available for the Board to review them. . . ."

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Writing Procedures: Drug & Device Wholesalers and HMDR - Online Study Course

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Tuesday, January 22, 2013

Exemptee Licensing Info and Resources - Exemptee Institute

Licensing - Exemptee Institute of SkillsPlus Intl Inc:

"The HMDR program is mandated by Assembly Bill 1496 of the 1999-2000 legislative session. This program licenses California HMDR facilities and registers Out-of-State HMDR facilities. In-State HMDR facilities supply prescription medical devices or durable medical equipment for use in the home to treat acute or chronic illnesses or injuries. Out-of-State HMDR facilities must supply prescription medical devices in order to qualify for the registration. The HMDR program also licenses exemptees that are required to be on staff in lieu of a pharmacist at facilities selling prescription medical devices as described under California and Federal medical device laws.

Useful License Links & Resources . . . "

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Friday, January 18, 2013

FraudBlawg - Most Viewed 2012 Posts

FraudBlawg 2012 in review « FraudBlawg:

"These are the posts that got the most views in 2012:
  1. Physical Therapy Fraud
  2. Former Inspector General Agent: TeenScreen Is “Dragnet for Pharmaceutical Industry”
  3. DME Fraud
  4. SouthernCare Hospice Pays Near $25 Million in Record Medicare Hospice Fraud Settlement
  5. Skilled Nursing Fraud"
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Thursday, January 17, 2013

What Is A Pharmacy Designated Representative?

If you're new to the world of the pharmacy Designated Representative, maybe this quick introduction will help. I'm going to explain, using the California (CA) State Board of Pharmacy as the example.

According to the CA Designated Representative application form:
A designated representative is an individual who performs clerical, inventory control, housekeeping, delivery, maintenance, or similar functions related to the distribution or dispensing of dangerous drugs or dangerous devices. To work as a designated representative, you must possess and keep a current certificate as a designated representative.

There are quite a number of requirements that have to be met in order to qualify, including the following training requirements listed on the application form:
Complete a training program that, at a minimum, addresses each of the following subjects:
(A) Knowledge and understanding of California and federal law relating to the distribution of dangerous drugs and dangerous devices.
(B) Knowledge and understanding of California and federal law relating to the distribution of controlled substances.
(C) Knowledge and understanding of quality control systems.
(D) Knowledge and understanding of the United States Pharmacopoeia standards relating to the safe storage and handling of drugs.
(E) Knowledge and understanding of prescription terminology, abbreviations, dosages and format.

The next step then becomes finding a way to fulfill the training program requirement. We recommend the highly popular California Pharmacy Designated Representative Certification Course by SkillsPlus International Inc. (CA State Approved).

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Tuesday, January 8, 2013

HMDR FAQs - Now Available from CDPH!

After a long absence, the HMDR FAQs are once again, available on the CA Department of Public Health website ...

HMDRLawsandFAQ-EM:

"The Home Medical Device Retailer (HMDR) licensing program is administered as part of the Medical Device Safety Section and is governed by law found in the California Sherman Food, Drug and Cosmetic Law.  The Sherman Law was amended in the 1999-2000 legislative session to establish the HMDR licensing program.  This section of the Sherman Law can be found by following the link below.  It is in the Adobe PDF format so you will need an Adobe reader program to open and print the document.  Also found below is a link to the compiled Frequently Asked Question (FAQ) list. "

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