Form Cdph 8695 PDF Details

The California Department of Public Health's CDPH 8695 form is a critical document for those seeking to either establish a new Home Medical Device Retailer (HMDR) Exemptee license or renew an existing one within the state. This comprehensive application process is designed to ensure that applicants meet the stringent standards set forth for the distribution and dispensing of various medical devices and drugs, underlining the state's commitment to safeguarding public health. Key components of the form include the applicant's personal and employment details, the legal obligations, and the certification by both the applicant and the employer. Additionally, it addresses the applicant's background with specific questions about education, training, and any felony convictions, aiming to confirm the applicant's qualifications and integrity. The form also requires detailed information about the HMDR facility, including the types of products dispensed and the operational specifics of the retail location. By mandating thorough documentation and employer certification, the form plays a pivotal role in regulating the industry and ensuring that only qualified individuals can distribute or dispense medical devices and drugs to the public.

QuestionAnswer
Form NameForm Cdph 8695
Form Length3 pages
Fillable?No
Fillable fields0
Avg. time to fill out45 sec
Other namescdph8695 licencee exemptee form

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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:

Date Received:

CID #

Amount:

$

PLEASE DO NOT WRITE ABOVE THIS LINE

Read instructions on attached sheet. Unsigned or incomplete applications will not be processed.

New Exemptee

Relocation

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:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5. Has the applicant ever been convicted of a felony? Yes

No If “yes,” provide an explanation on a separate sheet.

6.

 

(The following questions are for NEW APPLICANTS ONLY)

 

 

 

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

 

Has your current employer provided you with on-the-job training specific to your duties? (Attach records)

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

 

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.

7.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:

CDPH 8695 (09/09)

Fund Code 3018 Index 5624 PCA 76223 Receipt Source 125700 Agency Source 49

Page 1 of 3

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

8. Legal Name of Home Medical Device Retailer:

 

 

 

HMDR license number:

 

 

 

 

 

 

 

 

 

 

 

Business name: (if different)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Facility Address:

Number and Street

City

 

State

 

Zip Code

 

 

 

 

9. The applicant medical device retailer will sell the following products: (Check all that apply)

 

 

 

 

Respiratory Equipment / O2 Supplies

Incontinence Supplies

 

Walkers, Canes, Commodes

 

 

 

CPAPS, BiPAPS

 

Custom Wheelchairs

 

Hospital Beds / Mattresses

 

 

 

 

TENS Units

 

Power Wheelchairs

 

Other: Describe Below or attach list of products.

 

 

Infusion Pumps

 

Manual Wheelchairs

 

___________________________________________________

 

Catheters

 

Nutritional Supplements

 

 

 

 

 

 

 

 

 

 

CPM Machines

 

Diabetic Test Supplies

 

___________________________________________________

 

 

 

 

10.

Does this Home Medical Device Retailer currently employ the person whose name appears on this application?

Yes

No

 

 

 

 

11.

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:

 

 

 

______________________________________________________________

___________________________

 

 

 

 

 

 

 

 

12.

List business hours and days that the applicant will be working at this facility:

 

 

 

 

 

____________________________

 

 

 

 

 

 

 

 

13.

Enter other Exemptee license number(s) that applicant possesses:

 

 

 

 

 

 

_______________________________

 

 

 

 

 

 

 

14.

If applicant is working at various locations explain how facility intends to provide coverage in applicant’s absence:

 

 

______________________________________________________________________________________________________________

(attach a separate sheet if necessary)

15.Certification of Employer – Read carefully and sign below

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.

16. Employer’s original signature: (in blue ink)

Title of person signing:

Date:

17. License Fee Due (Fee is Non Refundable)

Enter Each Fee Below:

 

 

 

 

License fee (see page 3)

$

 

Late Fee ($10 if over 30 days late)

$

 

Total Payment Due

$

Make Checks Payable to: CALIFORNIA DEPARTMENT OF PUBLIC HEALTH See page 3 for mailing address

CDPH 8695 (09/09)

Fund Code 3018 Index 5624

PCA 76223 Receipt Source 125700 Agency Source 49

Page 2 of 3

State of California—Health and Human Services Agency

California Department of Public Health

 

Food and Drug Branch

Home Medical Device Retailer Exemptee License Application 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 working. 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.Felony: Has the applicant ever been convicted of a felony? If “Yes,” provide an explanation on a separate sheet.

6.Minimum qualifications:

•Education: High school diploma GED or equivalent. Attach copies of any applicable certifications or licenses that you may hold.

•On-the-Job Training: Attach copies of current employer’s training records listing job-specific training provided and dates completed.

•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.

7.Certification of Applicant: After reading the instruction paragraph your signature is needed, please sign in full (no initials) and date.

Numbers 8 through 16 are to be completed by the employer.

8.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.

9.Products type: Place an (x) in the boxes that correctly describe products that this firm handles (check all that apply).

10.Current Employment: Check the appropriate box to verify employment.

11.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)

12.Enter business days and hours of application at facility.

13.Enter any other Home Medical Device Retailer Exemptee license numbers applicant possesses.

14.Provide explanation of Home Medical Device Retailer facility coverage in controlling prescription products when applicant is unavailable.

15.& 16. 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.

17.Payment

 

License Category

Fee

 

 

Interval

 

Exemptee Application

$250.00

 

 

New ( Never licensed as Exemptee with FDB)

 

Fee / License fee

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exemptee License Fee

$150.00

 

 

Annual Renewal

 

 

 

 

 

 

 

Exemptee License Fee

$150.00

 

 

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:

California Department of Public Health

Food and Drug Branch - Cashier

P.O. Box 997435, MS-7602

Sacramento, CA 95899-7435

If you have any questions, please contact the Home Medical Device Retailer licensing desk at (916) 650-6500. You may also visit our internet web site at: http://www.cdph.ca.gov/programs/Pages/FDB.aspx for timely program news and a blank copy of this application form.

CDPH 8695 (09/09)

Page 3 of 3

How to Edit Form Cdph 8695 Online for Free

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This document needs some specific details; to guarantee accuracy, be sure to heed the subsequent suggestions:

1. The Form Cdph 8695 will require particular information to be typed in. Be sure the following blanks are filled out:

How to complete Form Cdph 8695 step 1

2. Once this array of fields is completed, it's time to add the required specifics in The following questions are for, Yes No Do you have a high school, Respiratory Therapist, Other Have you had one year or, Pharmacy Technician, LVN, Have you completed training, State and Federal laws relating to, State and Federal laws relating to, The United States Pharmacopoeia, The safe storage and handling of, Yes No, Yes No, Yes No, and Yes No so you're able to progress further.

Stage no. 2 in submitting Form Cdph 8695

3. This third segment is normally rather easy, Applicant Exemptee signature in, Date, and CDPH Fund Code Index PCA - every one of these form fields must be completed here.

Part number 3 in filling in Form Cdph 8695

4. Filling out Legal Name of Home Medical Device, Business name if different, HMDR license number, Facility Address The applicant, Number and Street, City, State, Zip Code, Respiratory Equipment O Supplies, Incontinence Supplies Custom, Walkers Canes Commodes Hospital, Does this Home Medical Device, Yes No, Will this person replace an, and Name of Exemptee being replaced is vital in the fourth form section - always take your time and fill in every blank!

Form Cdph 8695 conclusion process detailed (stage 4)

5. To wrap up your form, this final section has a number of additional fields. Completing List business hours and days that, Enter other Exemptee license, If applicant is working at, attach a separate sheet if, Certification of Employer Read, I hereby certify that the, Employers original signature in, Title of person signing, and Date should wrap up everything and you're going to be done quickly!

A way to fill out Form Cdph 8695 stage 5

Those who use this form often make some errors while filling in Employers original signature in in this area. You should re-examine everything you type in right here.

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