Showing posts with label readiness. Show all posts
Showing posts with label readiness. Show all posts

Friday, June 9, 2023

DSCSA Readiness - A Long Way To Go

Updated July 31, 2026

Companies Are Not Ready

The end to end pharmaceutical supply chain still isn't ready for DSCSA implementation.

Some articles are warning that the November 2023 date will be a challenge:

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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):

Monday, January 18, 2016

Be Ready! Common CDPH HMDR Facility Inspection Violations

Updated July 28, 2026

Common California HMDR Inspection Violations

California HMDR renewal inspections can take place annually, unannounced, at any HMDR facility during normal business hours. A customer complaint or other referral may trigger an inspection.

Common violations include:
  • Dispensing prescription devices without a valid HMDR exemptee on the premise
  • Lack of dispensing records for prescription devices
  • Inadequate procedures for the cleaning and maintenance of rental devices
  • Inadequate staff training or patient/caregiver consultation
  • Inadequate quality assurance procedures and/or lack of documentation of quality assurance procedures.
Source:   California HMDR FAQs on the Home Medical Device Retail Program website (unfortunately, the original source document is no longer posted).

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California HMDR Exemptee Training Certification Class. Earns a course completion certificate accepted by the California Department of Public Health - Food and Drug Branch
California HMDR Exemptee Training Certification Class. Earns a course completion certificate 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):

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