CA Home Medical Device Retailer (HMDR) FAQs

Healthcare Practitioner

“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.

…  Also found below is a link to the compiled Frequently Asked Question FAQ list [PDF].  These questions were collected during the establishment of the HMDR Program and represent the most frequently answered questions documented by department staff.”

View the webpage with links to the Sherman Law and HMDR FAQs: via HMDRLawsandFAQ-EM.


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FDA Law Blog: And So It Begins: FDA Issues First DSCSA Guidance

The FDA just published:  Guidance for Industry – Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification (PDF)

William Koustas (FDA Law Blog) writes, “The DSCSA tasked FDA with addressing three issues in this guidance: (1) identifying scenarios that could increase the risk of suspect product entering the supply chain; (2) recommending ways trading partners can identify and determine whether product is suspect; and (3) creating a process for trading partners to terminate illegitimate product notifications.  FDC Act § 582(h)(2).  The Draft Guidance addressed each of these three issues as follows:” . . .

Read the full article: via FDA Law Blog: And So It Begins: FDA Issues First DSCSA Guidance.


Go to DREprof.com: The Designated Representative and Exemptee Training Website

California HMDR Laws

“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.”

Read the full article: via HMDRLawsandFAQ-EM.
View the CA Sherman Food, Drug and Cosmetic Law (PDF)

In case you didn’t know:
The HMDR 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.


Go to DREprof.com: The Designated Representative and Exemptee Training Website

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