Form CDPH 8695 Application for Home Medical Device Retailer Exemptee License - New and Renewal - California

Form CDPH8695 is a California Department of Public Health form also known as the "Application For Home Medical Device Retailer Exemptee License '- New And Renewal". The latest edition of the form was released in April 1, 2018 and is available for digital filing.

Download an up-to-date Form CDPH8695 in PDF-format down below or look it up on the California Department of Public Health Forms website.

ADVERTISEMENT
Date Received:
CID #
Amount:
$
State of California—Health and Human Services Agency
California Department of Public Health
Food and Drug Branch
APPLICATION FOR HOME MEDICAL DEVICE RETAILER EXEMPTEE LICENSE – NEW AND RENEWAL
License Number:
PLEASE DO NOT WRITE ABOVE THIS LINE
Read instructions on attached sheet. Unsigned or incomplete applications will not be processed.
New Exemptee
Relocation
Ownership Change
Additional License
Renewal
1. Legal Name of Applicant:
Last
First
Middle
Former
Residence address:
Number and Street
City
State
Zip Code
Home phone number:
Date of birth:
If Renewal, Exemptee license No:
(
)
2. Name of HMDR facility where Exemptee will be working and / Business days and hours when Exemptee will be dispensing or
distributing prescription devices. (If currently employed by a HMDR facility.)
Address of HMDR facility:
Number and Street
City
State
Zip Code
Work phone number:
HMDR license number of employer (leave blank if unknown):
Expiration date:
(
)
3. Contact Name (if different from exemptee name):
4. Mailing Address (if different from HMDR facility):
City
State
Zip Code
(The following questions are for NEW APPLICANTS ONLY)
5.
Please provide the following information to determine if you meet the minimum qualifications.
Do you have a high school diploma or equivalent? (Attach a copy)
Yes
No
Do you hold any of the following professional certifications or licenses: (Attach a copy)
Respiratory Therapist
LVN
RN
PT
OT
Pharmacy Technician
Other
Have you had one year or more paid experience related to the distribution or dispensing of dangerous drugs or dangerous
devices? (Provide proof of 1 year experience)
Yes
No
Have you completed training program(s) that address the following: (Attach copy of completed training certificate)
State and Federal laws relating to the distribution of dangerous drugs and dangerous devices?
Yes
No
State and Federal laws relating to the distribution of controlled substances?
Yes
No
Knowledge and understanding of quality control systems?
Yes
No
The United States Pharmacopoeia standards relating to the safe storage and handling of drugs?
Yes
No
The safe storage and handling of home medical devices?
Yes
No
Prescription terminology, abbreviations, and format?
Yes
No
For all of the above questions answered yes, you must submit appropriate proof to verify qualifications.
6. Certification of Exemptee - Please read carefully and sign below
I understand that falsification of the information on this form may constitute grounds for denial or revocation of the license. I hereby
certify under penalty of perjury under the laws of the State of California to the truth and accuracy of all statements, answers and
representations made in this application, including all supplementary statements. I also certify that I personally completed this
application and have read and understand the instructions attached to this application.
Applicant Exemptee signature: (in full, no initials)
Date:
Fund Code 3018
Index 5624
PCA 76223
Receipt Source 125700
Agency Source 0049
Page 1 of 3
CDPH 8695 (04/18)
Date Received:
CID #
Amount:
$
State of California—Health and Human Services Agency
California Department of Public Health
Food and Drug Branch
APPLICATION FOR HOME MEDICAL DEVICE RETAILER EXEMPTEE LICENSE – NEW AND RENEWAL
License Number:
PLEASE DO NOT WRITE ABOVE THIS LINE
Read instructions on attached sheet. Unsigned or incomplete applications will not be processed.
New Exemptee
Relocation
Ownership Change
Additional License
Renewal
1. Legal Name of Applicant:
Last
First
Middle
Former
Residence address:
Number and Street
City
State
Zip Code
Home phone number:
Date of birth:
If Renewal, Exemptee license No:
(
)
2. Name of HMDR facility where Exemptee will be working and / Business days and hours when Exemptee will be dispensing or
distributing prescription devices. (If currently employed by a HMDR facility.)
Address of HMDR facility:
Number and Street
City
State
Zip Code
Work phone number:
HMDR license number of employer (leave blank if unknown):
Expiration date:
(
)
3. Contact Name (if different from exemptee name):
4. Mailing Address (if different from HMDR facility):
City
State
Zip Code
(The following questions are for NEW APPLICANTS ONLY)
5.
Please provide the following information to determine if you meet the minimum qualifications.
Do you have a high school diploma or equivalent? (Attach a copy)
Yes
No
Do you hold any of the following professional certifications or licenses: (Attach a copy)
Respiratory Therapist
LVN
RN
PT
OT
Pharmacy Technician
Other
Have you had one year or more paid experience related to the distribution or dispensing of dangerous drugs or dangerous
devices? (Provide proof of 1 year experience)
Yes
No
Have you completed training program(s) that address the following: (Attach copy of completed training certificate)
State and Federal laws relating to the distribution of dangerous drugs and dangerous devices?
Yes
No
State and Federal laws relating to the distribution of controlled substances?
Yes
No
Knowledge and understanding of quality control systems?
Yes
No
The United States Pharmacopoeia standards relating to the safe storage and handling of drugs?
Yes
No
The safe storage and handling of home medical devices?
Yes
No
Prescription terminology, abbreviations, and format?
Yes
No
For all of the above questions answered yes, you must submit appropriate proof to verify qualifications.
6. Certification of Exemptee - Please read carefully and sign below
I understand that falsification of the information on this form may constitute grounds for denial or revocation of the license. I hereby
certify under penalty of perjury under the laws of the State of California to the truth and accuracy of all statements, answers and
representations made in this application, including all supplementary statements. I also certify that I personally completed this
application and have read and understand the instructions attached to this application.
Applicant Exemptee signature: (in full, no initials)
Date:
Fund Code 3018
Index 5624
PCA 76223
Receipt Source 125700
Agency Source 0049
Page 1 of 3
CDPH 8695 (04/18)
State of California—Health and Human Services Agency
California Department of Public Health
Food and Drug Branch
THIS AREA IS TO BE COMPLETED BY THE EMPLOYER (If Applicant is currently employed by a HMDR facility.)
7. Legal Name of Home Medical Device Retailer:
HMDR license number:
Business name: (if different)
Facility Address:
Number and Street
City
State
Zip Code
8. The applicant medical device retailer will sell the following products: (Check all that apply)
Respiratory Equipment / O2 Supplies
Incontinence Supplies
Walkers, Canes, Commodes
Hospital Beds / Mattresses
CPAPS, BiPAPS
Custom Wheelchairs
Other: Describe Below or attach list of products.
TENS Units
Power Wheelchairs
Infusion Pumps
Manual Wheelchairs
___________________________________________________
Catheters
Nutritional Supplements
___________________________________________________
CPM Machines
Diabetic Test Supplies
9. Does this Home Medical Device Retailer currently employ the person whose name appears on this application?
Yes
No
10. Will this person replace an Exemptee licensed by the California Department of Public Health?
Yes
No (Attach copy)
Name of Exemptee being replaced :
Exemptee Number:
______________________________________________________________
___________________________
11. List business hours and days that the applicant will be working at this facility:
____________________________
12. Enter other Exemptee license number(s) that applicant possesses:
_______________________________
13. If applicant is working at various locations explain how facility intends to provide coverage in applicant’s absence:
______________________________________________________________________________________________________________
(attach a separate sheet if necessary)
Certification of Employer – Read carefully and sign below
14.
I hereby certify that the application completed on this form is being presented to the Food and Drug Branch with my
knowledge and approval. Also, it is my understanding that a person certified by the Food and Drug Branch must be
on the premises and actively supervising operations at all times when prescription devices are being dispensed. I
certify under penalty of perjury under the laws of the State of California to the truth and accuracy of all statements,
answers, and representations made in the foregoing application, including all supplementary statements.
15. Employer’s original signature: (in blue ink)
Title of person signing:
Date:
License Fee Due (Fee is Non Refundable)
Enter Fee Below:
16.
License fee due (see page 3)
$
Make Checks Payable to:
CALIFORNIA DEPARTMENT OF PUBLIC HEALTH
See page 3 for mailing address
Fund Code 3018
Index 5624
PCA 76223
Receipt Source 125700
Agency Source 0049
Page 2 of 3
CDPH 8695 (04/18)
State of California—Health and Human Services Agency
California Department of Public Health
Food and Drug Branch
Home Medical Device Retailer Exemptee License A pplication Instructions
Please complete and/or amend this application as is most appropriate to your facility. Include the appropriate fee for each application as
indicated in the fee schedule and make check payable to: CA DEPARTMENT OF PUBLIC HEALTH. The application cannot be processed
without the appropriate fees, complete documentation and appropriate signatures. Unsigned or incomplete applications cannot be
processed and will be returned. The following are further instructions on how to complete this application:
1.
Your Information: Your legal name as it is to appear on the license issued by the Department of Public Health. Residence address:
Enter the number, street, city, state and Zip code for your residence. If this is a renewal, enter your current Exemptee license
number.
2.
Employer Information: The legal name of the Home Medical Device Retailer facility where you will be distributing prescription
devices. (If currently employed by a HMDR facility.) Address: Enter the number, street, city, state and Zip code for this facility.
3.
Correspondent: Enter the name of the person to contact for information regarding this application and their title.
4.
Mailing Address: This address is where licensing information is to be sent if the address is a different location than the Employer
address.
5.
Minimum qualifications:
Education: High school diploma GED or equivalent. Attach copies of any applicable certifications or licenses that you
may hold.
Work Experience: One or more years paid experience, attach dates, name(s) of employer(s), and addresses. Training
must have been supervised by a licensed exemptee, Pharmacist-In-Charge or equivalent.
Training Programs: Indicate by yes or no the training you have completed specific to the five topics listed. Attach
copies of certificates or transcripts.
6.
Certification of Applicant: After reading the instruction paragraph your signature is needed, please sign in full (no initials) and
date.
Numbers 7 through 16 are to be completed by the employer. (If currently employed by a HMDR facility.)
7.
Name of Firm: Enter the full name of the business, HMDR license: Enter the current Home Medical Device Retailer facility license
number. Corporate Name: Name of corporation if different from HMDR name. Facility Address: Enter the number, street, city,
state and Zip code for this facility location.
8.
Products type: Place an (x) in the boxes that correctly describe products that this firm handles (check all that apply).
9.
Current Employment: Check the appropriate box to verify employment.
10.
Replacement of Licensed Exemptee: Check box: if applicant is replacing a licensed Exemptee. Name: Exemptee being replaced.
Certificate number: Exemptee being replaced certificate number. (Attach copy)
11.
Enter business days and hours of application at facility.
12.
Enter any other Home Medical Device Retailer Exemptee license numbers applicant possesses.
13.
Provide explanation of Home Medical Device Retailer facility coverage in controlling prescription products when applicant
is unavailable.
14. & 15.
Certification of Employer: After reading the instruction paragraph the employer’s original signature is needed, please
sign, state title of signatory and date the signature.
16.
Payment
License Category
Fee
Interval
Exemptee Application
$384.00
New (Never licensed as Exemptee with FDB)
Fee / License fee
Exemptee License Fee
$230.00
Annual Renewal
Exemptee License Fee
$230.00
Additional license, Relocation, Change of Ownership
**
LICENSE FEES ARE NON-REFUNDABLE AND NON-TRANSFERABLE TO OTHER LOCATIONS OR ENTITIES
MAKE CHECKS PAYABLE TO:
California Department of Public Health
MAIL APPLICATION AND CHECK TO:
Regular Mail: California Department of Public Health
Overnight Mail: California Department of Public Health
Food and Drug Branch - Cashier
Food and Drug Branch - Cashier
MS 7602
1500 Capitol Avenue, MS-7602
P.O. Box 997435
Sacramento, CA 95814
Sacramento, CA 95899-7435
If you have any questions, please contact the Home Medical Device Retailer Exemptee Licensing Desk at (916) 341-7354,
(800) 495-3232.
Page 3 of 3
CDPH 8695 (04/18)

Download Form CDPH 8695 Application for Home Medical Device Retailer Exemptee License - New and Renewal - California

843 times
Rate
4.6(4.6 / 5) 51 votes
ADVERTISEMENT
Page of 3