Thursday, August 29, 2013

Exemptee Training - HME DME - Meets CDPH HMDR Requirements

The HMDR Exemptee Plays A Vital Role:
  • In order to dispense prescription (Rx) devices from your HMDR (Home Medical Device Retailer) facility you must employ either a licensed pharmacist, or a licensed HMDR Exemptee. For a description of HMDR Exemptee requirements, refer to the California Health and Safety Code, Division 104, Part 5, Section 111656.4 (a).
Background*:
  • A HMDR facility is defined as any area, place, or premises [other than a licensed pharmacy] in and from which prescription (Rx) devices, home medical devices, or home medical device services are stored, sold, fitted, or dispensed pursuant to a prescription at retail.
  • A HMDR warehouse is owned by the HMDR facility and is a separate place where prescription (Rx) home medical devices are stored and transported to the firm's existing licensed HMDR facility (NOT direct to patients’ homes). There may not be any fitting, display, or sales at this facility. The warehouse is used for storage only.
  • An individual may submit an application for an Exemptee license on their own behalf or a licensed HMDR operator may submit an Exemptee license application for a current employee for the purpose of dispensing prescription medical devices from that particular facility. In either case, the applicant must meet the required knowledge and training mandated by California Health and Safety Code, Division 104, Part 5, Section 111656.4 (a). This law requires one year of work experience in a facility where dangerous drugs and/or dangerous devices are dispensed, evidence of high school graduation or GED equivalent, and evidence that the applicant has completed a training course that addresses areas of HMDR knowledge and training.
  • The HMDR Law can be found in the California Health and Safety Code, Sections 111656 through 111656.13 of the Sherman Food, Drug, and Cosmetic Law (PDF)
* Source: Home Medical Device Retailer (HMDR) Frequently Asked Questions (PDF)

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