Division of Professions and Occupations Office of Licensing—Pharmacy 1560 Broadway, Suite 1350 Denver, CO 80202 (303) 894-7800 / Fax (303) 894-7693 www.dora.colorado.gov/professions
Application for Registration IN-STATE MANUFACTURER OF PRESCRIPTION DRUGS (MFR) New Registration or Transfer Ownership: $450 Change Location: $125 Change Name: $35 Fees may be paid by a check or money order drawn in U.S. dollars on a U.S. bank and made payable to State of Colorado
(This application must also be used for changes to existing registrations.) APPLICANT INSTRUCTIONS Basic Requirements. Requirements for registration are outlined in the Colorado Revised Statutes, specifically Section 1242.5-112 and the Board rules. Both can be found online at www.dora.colorado.gov/professions/pharmacy. About the Application. This application is to be completed by you and returned to the Office of Licensing. All questions on the application are mandatory, and all supporting documents must be submitted with the application. You may copy as many forms as needed; however, each form submitted must be completed in original ink or typed. Be sure to keep a copy of the completed application for your records. Application Good for One Year. Your application will be kept on file for one year from date of receipt. Your file and all supporting documentation will be purged if you do not submit required documents and complete your application process in one year. You will need to resubmit a new application packet and fee after that time. Disclosure of Addresses. Consistent with Colorado law, all addresses and phone numbers on record with the Division are public record and must be provided to the public when requested. It is your responsibility to keep your contact information current in our system. Your email address is not open to public record, but must be provided in this application. Any requests for additional information, license information and renewal notices will be emailed to the email address on record. If your email address is not current, it is possible you will not receive important information from the Division. You can change your contact information online by using Online Services at: www.dora.colorado.gov/professions/onlineservices. Checking Your Application Status. Visit Online Services at: www.dora.colorado.gov/professions/onlineservices to track your application from the date we log it in our database to the date your license is available for printing. Please allow us enough time to receive the application through the mail and enter your application into our database before you check the website. We recommend waiting at least 10 business days from date of mailing before checking the status of your application. Registration Expiration Grace Period for New Applicants. All new applicants who are issued a registration within 120 days of the upcoming renewal expiration date will be issued a registration with the subsequent expiration date. For example, registration issued between July 4, 2016 and October 31, 2016 will reflect an expiration date of October 31, 2018. Registrations issued prior to July 4, 2016 will reflect an expiration date of October 31, 2016 and must renew in the upcoming renewal period.
All in-state manufacturer registrations expire on October 31 of even-numbered years and must be renewed to continue practicing.
Printing your Registration upon Approval. DORA is no longer printing and mailing wallet cards as registrations. To print your wallet card registration in its current status, login to your Online Services account at: www.dora.colorado.gov/professions/onlineservices and select “Print Your License” in the left-hand menu.
Applicant: Keep this page for your records.
06/2015
Division of Professions and Occupations Office of Licensing—Pharmacy 1560 Broadway, Suite 1350 Denver, CO 80202 (303) 894-7800 / Fax (303) 894-7693 www.dora.colorado.gov/professions
Application for Registration IN-STATE MANUFACTURER OF PRESCRIPTION DRUGS (MFR) New Registration or Transfer Ownership: $450 Change Location: $125 Change Name: $35 Fees may be paid by a check or money order drawn in U.S. dollars on a U.S. bank and made payable to State of Colorado
APPLICANT CHECKLIST For a new registration as a manufacturer, or to transfer ownership of a current registration: Submit a completed application with the non-refundable application-processing fee. See application form for current fees. Submit a Certificate of Good Standing issued by the Colorado Secretary of State. Submit proof of registration with the Food and Drug Administration. If you are reporting a transfer of ownership: Upon completion of the transfer, submit a statement signed by both the purchaser and seller stating that the transfer is complete and the effective date of the transfer. Return your completed application packet and all supporting documentation to: Division of Professions and Occupations Office of Licensing—Pharmacy 1560 Broadway, Suite 1350 Denver, CO 80202
Applicant: Keep this page for your records.
06/2015
Division of Professions and Occupations Office of Licensing—Pharmacy 1560 Broadway, Suite 1350 Denver, CO 80202 (303) 894-7800 / Fax (303) 894-7693 www.dora.colorado.gov/professions
Application for Registration IN-STATE MANUFACTURER OF PRESCRIPTION DRUGS (MFR) New Registration or Transfer Ownership: $450 Change Location: $125 Change Name: $35 Fees may be paid by a check or money order drawn in U.S. dollars on a U.S. bank and made payable to State of Colorado
The content of this application must not be changed. If the content is changed, the applicant may be referred to the Colorado State Attorney General’s Office for violation of Colorado law.
•
Return the completed application with all supporting documentation attached. Please legibly print or type all information in the application. • Fees may be paid by a check or money order drawn in U.S. dollars and made payable to State of Colorado. All fees are non-refundable and subject to change every July 1. • The content of this application must not be changed. If the content is changed, the applicant may be referred to the Colorado State Attorney General’s Office for violation of Colorado law. If additional pages are attached to respond to requested information in any part of the application, please indicate the number of the item to which you are responding. PART 1. Select from the following: I am submitting an application for new In-State Manufacturer registration. Enclose fee with your application and continue to Part 2. —OR— I am reporting a Transfer of Ownership for a current registration. Effective date of new ownership: Previous owner name: Enclose fee with your application and continue to Part 2. —OR— I am reporting a change in existing registration as follows: (select all that apply) Change of Location Previous location: Effective date of location change: Change of Business Name Effective date of new name: Previous business name: Total Fee:
$450
$450
$125
$35
$
PART 2. 1. Colorado Registration Number:
If this is a new registration, leave blank.
2. Business Name: List all trade names or DBA names used by business:
3. Attach, on a separate sheet of paper, a list of the names, addresses, telephone numbers, and names of contact persons for all facilities used by the applicant for the storage, handling, and distribution of prescription drugs. 4. Attach, on a separate sheet of paper, a list of all states that have issued permits or licenses to the applicant to purchase or possess prescription drugs. Include the permit number and type of permit.
OFFICE USE ONLY Page 1 of 4
REGISTRATION NUMBER: ________________________
DATE ISSUED: ______________________________ 06/2015
5. Federal Employer Identification Number (FEIN): 6. Address: Street & Number
7. Daytime Telephone:
City
State
Zip Code
E-mail Address:
8. Type of Ownership (check one and complete information as applicable): Sole proprietor Full name of owner: Owner’s Social Security Number: Partnership Name of Partnership: Federal Employer Identification Number: List full name and Social Security Number of each partner (attach additional pages if necessary):
Corporation ATTACH A STATEMENT to this application listing the following: Name, Social Security Number, and title of each corporate officer and director Name of parent company, if any Corporate names and state of incorporation Federal Employer Identification Number of the business entity Limited Liability Corporation ATTACH A STATEMENT to this application listing the following: Name of Limited Liability Corporation Name, Social Security Number, and title of each member Name of parent company, if any State of incorporation Federal Employer Identification Number of the business entity Limited Liability Partnership ATTACH A STATEMENT to this application listing the following: Name of Limited Liability Partnership Name, Social Security Number, and title of each member Name of parent company, if any Federal Employer Identification Number of the business entity
Page 2 of 4
06/2015
9. Designated Contact Person: This is the person who is responsible for the operation of the facility in compliance with all applicable laws, rules, and regulations pertaining to drugs and devices. He or she must include a resume and complete the affidavit below. Full name and title: Telephone number: Educational background:
Social Security Number: Length of service with applicant:
10. Contact Person Affidavit: I, , certify that I am the designated contact person for the within named applicant. I further certify that the information contained in this application is true and correct. I further certify that I am familiar with the requirements of the Federal Food, Drug & Cosmetic Act and its supporting regulations. Signature
Date
Changes to any of the information supplied in this section, including change in name or title of the Designated Contact Person, must be submitted in writing to the Board within 15 days of such change.
Page 3 of 4
06/2015
PART 3. 11. Background Questions: If the answer to any question is YES, attach additional pages and explain fully. A. Has the applicant or any person identified in this application been convicted under any federal, state, or local law relating to drug samples, drug manufacturing, drug dispensing, wholesale or retail drug distribution, or distribution of controlled substances?
YES
NO
B. Has the applicant or any person identified in this application had any criminal or civil conviction under federal or state laws? (This includes deferred judgments or sentences.)
YES
NO
C. Has any person identified in this application had any license or registration to manufacture, dispense, or distribute legend drugs or controlled substances suspended or revoked?
YES
NO
D. Has any person identified in this application been convicted of a felony, pled nolo contendere, or received a deferred judgment or deferred sentence to a felony under any federal, state, or local law?
YES
NO
E. Has any registration or license to manufacture or distribute legend drugs and/or controlled substances currently or previously held by applicant ever been suspended or revoked?
YES
NO
12. Personnel: Does applicant have a system which ensures that all employees engaged in distribution have the appropriate education and/or experience to properly assume responsibility and act in compliance with applicable federal and state laws and regulations?
YES
NO
If the answer is NO, attach additional pages explaining fully when and how compliance will be achieved.
13. Customers: Drugs, which are manufactured, will be distributed to the following (please check all that apply): Community Pharmacies Hospital Pharmacies Wholesalers “Other Outlets” [these are non-pharmacy outlets where drugs are dispensed] Physicians and other practitioners licensed to prescribe Person responsible for control of animal if distributing veterinary drugs
Per § 12-4-104(13)(a), C.R.S., any applicant who, under oath, supplies false information to an agency in an application for a license, commits perjury in the second degree as defined in § 18-8-503. C.R.S. In accordance with §§ 18-8-503 and 18-8-501(2)(a)(l), C.R.S., false statements made herein are punishable by law. THIS APPLICATION COMPLETED BY: Signature: Name:
Page 4 of 4
Date: Title:
06/2015
