Exemptee Certification California HMDR and Durable Medical Equipment Providers
By SkillsPlus International

Welcome to the SkillsPlus CA Exemptee Certification training support center. This page provides links to a variety of GMP compliance and training products and services made available by SkillsPlus. 

Exemptee Certification for Department of Health Services (DHS)

Writing Procedures: Drug Wholesalers and HMDR Retailers

 

Department of Health Services Training Guidelines

California requires drug and device wholesalers and home medical device retailers to retain on-site, a California-licensed pharmacist or Exemptee / Designated Representative to conduct their business.  The pharmacist, Exemptee or Designated Representative must be physically present during all hours of operation. This course is recommended by both the California Board of Pharmacy and DHS for their respective training requirements.

To meet this requirement, we offer a web-based, self-study class and the final exam for this certification. The class is fast,

Refresher Course Enrollment Form - Do not use this for initial training. The rules are constantly changing and you must be up to date. The Department of Health field inspectors are now asking some Exemptees for evidence of refresher training. 

Two Ways to Study To Prepare For the Exam

Current Average Grade for All Students - 94.13% - Updated 11/6/2009

 

State Applications

Department of Health Services Exemptee and Facility Application

Web Self-study - Click to learn about this least expensive way to prepare for and take the exam.

Adobe Flash Player 10 - Free Download

 

Questions and Answers

Pedigree Q&A from the Board of Pharmacy

Downloadable information about this class and off line registration

Experienced at helping firms to complete State approvals. Click

 

Need to know the status of your fingerprint scan at the FBI? Call the FBI Fingerprinting office in West Virginia. The applicant for the scan must be the one to call. Call 304.625.5590

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Special Notice for Drug Manufacturers - Click here

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SkillsPlus International now offers the
Designated Representative Certification / Exemptee
Web Based Self-Study Class

California Board of Pharmacy
and
Department of Health and Safety - Food and Drug Branch

Objectives:

  1. Knowledge and understanding of state and federal law relating to the distribution of dangerous drugs and dangerous devices.

  2. Knowledge and understanding of state and federal laws relating to the distribution of controlled substances.

  3. Knowledge and understanding of quality control systems.

  4. Knowledge and understanding of the United States Pharmacopoeia standards relating to the safe storage and handling of drugs.

  5. Knowledge and understanding of prescription terminology, abbreviations, dosages and format.

  6. Knowledge of Health and Safety Code - HMDR.

Topics:

  1. California Code of Regulations
  2. California Business and Professional Code
  3. USP Storage and Handling of Drugs
  4. Controlled Substances 
  5. Health and Safety Code - HMDR
  6. Quality Systems for drugs and devices

Evidence of Completion: 


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Designated Representative - California Board of Pharmacy

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Exemptee Certification - California Department of Health

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Notice for Drug Manufacturers - This notice is provided as a courtesy. It is the firm's responsibility to assure these exceptions apply to you.

 

Drug Manufacturers no longer need a Designated Representative if you are under the authority of the Food and Drug Branch and the Food and Drug Administration or licensed pursuant to Section 111615 of the Health and Safety Code. You are referred to 4160(e).

 

4169(a) States that an entity may not purchase, sell, trade, or transfer dangerous drugs and devices.

4169(d) States that this does not apply to certain pharmaceutical manufacturers licensed by the FDA or by the State Department of Health Services. 

 

Separate distribution centers need a license and a Designated Representative. 

 

Experience Requirements: If you do not have one year of paid work experience in the last three years involving the distribution of dangerous drugs and devices you most likely are not qualified to become the Designated Representative or Exemptee. Please contact our office for clarification. Telephone 415.487.3500.

 

Animal Drug Retailers - This course may not meet the requirements for animal drug retailers. Please check with the board for current status. Typically animal drug retailer courses require extensive training in the drugs and dosages as well as the regulatory aspect of drugs.

 

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Please give us a call for any clarification.