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 PRESCRIPTION DRUG OUTLET (Pharmacy) New Registration or Transfer Ownership: $450 Change Location: $125 Change Name or Change Manager: $35 Remodel Compounding/Dispensing Area or Satellite Facility:
No fee 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 Section 12-42.5-112 of the Colorado Revised Statutes (C.R.S.) 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 Expiration. Your application will be kept on file for one year from date of receipt in the Division. 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, registrations 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 prescription drug outlet 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.
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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 PRESCRIPTION DRUG OUTLET (Pharmacy) New Registration or Transfer Ownership: $450 Change Location: $125 Change Name or Change Manager: $35 Remodel Compounding/Dispensing Area or Satellite Facility:
No fee 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 NEW REGISTRATION as a Prescription Drug Outlet or to TRANSFER OWNERSHIP of a current registration: Submit a completed application and supporting documentation if required. Return the completed application and all supporting documentation to the Office of Licensing. Enclose the non-refundable application processing fee. Fees may be paid by check or money order drawn in U.S. dollars on a U.S. bank and made payable to State of Colorado. All fees are non-refundable and subject to change every July 1. If the owner of the prescription drug outlet is a corporation, you may either: Submit a copy of the Articles of Incorporation as they are filed with the Colorado Secretary of State, showing the filing stamp; —OR— Submit a Certificate of Good Standing issued by the Colorado Secretary of State. If the pharmacy purports to be a hospital pharmacy which dispenses prescriptions pursuant to chart orders: Submit a copy of a certificate from the Colorado Department of Public Health and Environment which designates the facility as a hospital. Submit a letter stating whether the corporation is public or private as follows: If the corporation is a public corporation, submit a list of all stockholders owning five percent or more of the stock. If the corporation is a private corporation, submit a list of all stockholders. Submit a drawing of the prescription department(s) showing the counters, bays, sink, and refrigerator (and hood, if appropriate). The drawing must be accurate and drawn to scale, and the scale must be stated. An architect’s plan or blueprint is not required. The drawing can be on plain or graph paper. Submit the attached Minimum Equipment Self-Inspection Form, completed, dated, and signed. Submit a statement signed by the pharmacist manager stating whether or not the business is owned in greater than 10% by a person or persons authorized to prescribe drugs. The term “person” shall include any person or persons, partnership, or business entity in which the person or persons authorized to prescribe drugs has an ownership interest individually or jointly greater than 10%.
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 PRESCRIPTION DRUG OUTLET (Pharmacy) New Registration or Transfer Ownership: $450 Change Location: $125 Change Name or Change Manager: $35 Remodel Compounding/Dispensing Area or Satellite Facility:
No fee 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 (Continued) If you are reporting a transfer of ownership: Submit a statement signed and dated by both the purchaser and seller stating that the transfer is complete. This must be submitted after the transfer is finalized. The Board will not complete the transfer until this has been received. Once all information has been received and reviewed, Board staff will be in contact to set up a date and time for an inspection. To CHANGE THE LOCATION of an existing registration: Submit a completed application and supporting documentation if required. Return the completed application and all supporting documentation to the Office of Licensing. Enclose the non-refundable application processing fee. Fees may be paid by check or money order drawn in U.S. dollars on a U.S. bank and made payable to State of Colorado. All fees are non-refundable and subject to change every July 1. Submit a drawing of the prescription department(s) showing the counters, bays, sink, and refrigerator (and hood, if appropriate). The drawing must be accurate and drawn to scale, and the scale must be stated. An architect’s plan or blueprint is not required. The drawing can be on plain or graph paper. Indicate where the pharmacy’s sink and refrigerator will be located within this drawing. Submit the attached Minimum Equipment Self-Inspection Form, completed, dated, and signed. Once all information has been received and reviewed, Board staff will be in contact to set up a date and time for an inspection. To CHANGE THE NAME OR THE PHARMACIST MANAGER on an existing registration: Submit a completed application and supporting documentation if required. Return the completed application and all supporting documentation to the Office of Licensing. Enclose the non-refundable application processing fee. Fees may be paid by check or money order drawn in U.S. dollars on a U.S. bank and made payable to State of Colorado. All fees are non-refundable and subject to change every July 1. To REMODEL THE COMPOUNDING/DISPENSING AREA on an existing registration: Submit a completed application and supporting documentation if required. Return the completed application and all supporting documentation to the Office of Licensing. Submit a drawing of the prescription department(s) showing the counters, bays, sink, and refrigerator (and hood, if appropriate). The drawing must be accurate and drawn to scale, and the scale must be stated. An architect’s plan or blueprint is not required. The drawing can be on plain or graph paper. Indicate where the pharmacy’s sink and refrigerator will be located within this drawing.
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 PRESCRIPTION DRUG OUTLET (Pharmacy) New Registration or Transfer Ownership: $450 Change Location: $125 Change Name or Change Manager: $35 Remodel Compounding/Dispensing Area or Satellite Facility:
No fee 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 (Continued) Submit the attached Minimum Equipment Self-Inspection Form, completed, dated, and signed. If the prescription compounding area is moved into temporary quarters during remodeling, the temporary quarters must meet all physical space, equipment, and security requirements, including counter space, functioning sink, and refrigeration. A separate application will be required. If temporary quarters will be required, please indicate this fact in a letter. You must submit floor plans for both the temporary quarters and the proposed remodel area. You must also submit a minimum equipment self-inspection form as soon as you move into the temporary quarters, and another minimum equipment self-inspection form as soon as you move into the remodeled area. To OPEN A SATELLITE FACILITY for an existing registration (AT ONLY THE SAME LOCATION AS THE EXISTING PRESCRIPTION DRUG OUTLET REGISTRATION): Submit a completed application and supporting documentation if required. Return the completed application and all supporting documentation to the Office of Licensing. Submit a drawing of the prescription department(s) showing the counters, bays, sink, and refrigerator (and hood, if appropriate). The satellite facility must be at least 100 square feet. The drawing must be accurate and drawn to scale, and the scale must be stated. An architect’s plan or blueprint is not required. The drawing can be on plain or graph paper. Submit the attached Minimum Equipment Self-Inspection Form, completed, dated, and signed. A satellite facility MUST be inspected before you can move into the space. This application does NOT apply to, nor shall it be used for, a hospital satellite placed at a separate location from the registered prescription drug outlet. Return your completed application packet and all supporting documentation to: Division of Professions and Occupations Office of Licensing—Pharmacy 1560 Broadway, Suite 1350 Denver, CO80202
Applicant: Keep this page for your records.
06/2015
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 Prescription Drug Outlet 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 location change: Change of Business Name Effective date of new name: Previous business name: Change of Manager Previous Manager: Effective date of change: Remodeling the Compounding/Dispensing Area
$450
$450
$125
$35
$35
No fee
Opening Satellite Facility (ONLY at the same location as the pharmacy) Required – If storing prescription drug stocks (i.e. - large volume IV fluids) at the same location in areas other than the designated compounding/dispensing area. Total Fee:
No fee
$
PART 2. 1. Colorado Registration Number:
If this is a new registration, leave blank.
2. DEA Registration Number: 3. Business Name: List all trade names or DBA names used by business:
Prescription Drug Outlet
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4. Federal Employer Identification Number (FEIN): 5. Address: Street & Number
City
6. Daytime Telephone:
• • •
State
Zip Code
E-mail Address:
IMPORTANT You MUST file for a Transfer of Ownership: If the prescription drug outlet is owned by a corporation, upon the sale or transfer of 20% or more of the shares to a single individual or entity. Upon the sale or transfer of any ownership interest of 20% or more to a single individual or entity. Upon the incorporation of an existing Prescription Drug Outlet.
7. Type of Ownership (check one and complete information as applicable): Individual, trustee, or receiver Name: Partnership (including Limited Liability Partnership) Name of partnership: Date of last report to the Colorado Secretary of State (if appropriate): Corporation (including Limited Liability Corporation and Non-Profit Corporation) Name of corporation: State where incorporated: Date of last corporate report to the Colorado Secretary of State: Corporate officers (attach additional pages if necessary): Name
Title
Social Security Number
8. Pharmacist Manager: This is the person who is responsible for the legal operation of the facility in compliance with all applicable laws, rules, and regulations. Name of Pharmacist Manager: License Number:
Date Manager’s Duties and Responsibilities Were Assumed:
If you are reporting a change of manager, you must also provide the following: Name of Previous Pharmacist Manager: License Number:
Last Date Employed as Pharmacist Manager:
9. Pharmacist Manager Affidavit: I, , certify that I am the designated pharmacist manager for the within named applicant. While I am manager, I accept responsibility for the legal operation of this outlet pursuant to §§12-42.5-116 and 12-42.5-102(29) C.R.S. and Regulation 7.00.00. I will immediately notify the Board of Pharmacy if and when I terminate my employment with this pharmacy.
Signature
Date Changes to any of the information supplied in this section, including change of Pharmacist Manager, must be submitted in writing to the Board within 30 days of such change.
Prescription Drug Outlet
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PART 3. 10. 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 disciplined, suspended, or revoked?
YES
NO
D. Has any person identified in this application been convicted of a felony or pled nolo contendere 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 disciplined, suspended or revoked?
YES
NO
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 C.R.S. 18-8-501(2)(a)(l), C.R.S., false statements made herein are punishable by law. The Owner and Pharmacist Manager agree that the Board has the power to inspect all outlets and investigate violations pursuant to § 12-42.5-106, C.R.S. The Owner and Pharmacist Manager agree to submit data to the Prescription Drug Monitoring Program pursuant to § 12-42.5-407, C.R.S. Specific information regarding this program may be obtained at: www.dora.colorado.gov/professions/pharmacy
THIS APPLICATION COMPLETED BY: Signature:
Date:
Name:
Title:
FOR NEW REGISTRATIONS, OWNERSHIP TRANSFERS, BUSINESS RELOCATIONS, REMODELS, or NEW SATELLITES (at SAME location as the pharmacy): Date you anticipate the compounding/dispensing area(s) will be ready for inspection: Date you expect the compounding/dispensing area(s) to be open for business:
Hours of Operation: Monday: Tuesday: Wednesday: Thursday:
Prescription Drug Outlet
Friday: Saturday: Sunday:
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MINIMUM EQUIPMENT SELF-INSPECTION
Name of Pharmacy: Complete Address: Phone Number (include area code): CHECK ALL THAT APPLY: NEW PHARMACY Self-Inspection Form TRANSFER OF OWNERSHIP Self-Inspection Form CHANGE OF LOCATION Self-Inspection Form REMODELED COMPOUNDING/DISPENSING AREA Self-Inspection Form SATELLITE Self-Inspection Form (For ONLY a satellite at the same location as the pharmacy) IMPORTANT: APPLICANT MUST COMPLETE THIS BOX ENTER THE NUMBER OF SQUARE FEET IN THE PRINCIPAL COMPOUNDING/DISPENSING AREA: May not be less than 225 continuous square feet ENTER THE NUMBER OF SQUARE FEET IN THE SATELLITE COMPOUNDING/DISPENSING AREA: May not be less than 100 continuous square feet
INSTRUCTIONS: If the pharmacy is in complete compliance with the paragraph, please write “OK” on the line to the left of the paragraph. _____ Each compounding/dispensing area shall be well-lighted and well-ventilated with clean and sanitary surroundings devoted primarily to the compounding of prescriptions and the manufacture of pharmaceutical preparations. The area shall provide necessary protection for drugs, chemicals and devices from deterioration due to light, heat or evaporation. It shall be arranged as to protect all prescription drugs and devices from pilferage and other unauthorized removal. The area shall not be subject to any condition likely to lead to errors. _____ There shall be a minimum of 12 continuous square feet of compounding/dispensing area for the pharmacist, and a minimum of 6 continuous square feet of compounding/dispensing area for each additional person engaged in dispensing. These areas shall be kept free and clear at all times for the purpose of dispensing. Any computer work station or other equipment for the preparation of prescription labels and/or storage and retrieval of records shall be in addition to the minimum free dispensing area. The free floor space behind the prescription compounding/ dispensing counter shall be not less than 30 inches in width. The free floor space between shelf sections shall be not less than 24 inches. In the principal compounding/dispensing area there shall be a sink, equipped with running hot and cold water, which is attached to an approved drain, waste and vent system or to a portable enclosed tank, which is emptied as frequently as necessary. Each satellite area shall also be so equipped if appropriate to the compounding/dispensing activities which are or will be performed therein. There shall be sufficient shelf, drawer or cabinet space for proper storage of prescription drugs and devices. _____ The free floor space behind the prescription compounding/dispensing counter(s) shall be not less than 30 inches in width. _____ The free floor space between shelf sections shall be not less than 24 inches.
Minimum Equipment Self-Inspection
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_____ There is a sink, equipped with running hot and cold water, which is attached to an approved drain, waste and vent system or to a portable enclosed tank, which is emptied as frequently as necessary. Each satellite area is also so equipped if appropriate to the compounding/dispensing activities which are or will be performed therein. _____ There shall be sufficient shelf, drawer or cabinet space for proper storage of prescription drugs and devices.
SECTION 5.01.31(e) – All prescription drug outlets must have the following minimum equipment within at least one of the compounding/dispensing areas. _____ Refrigeration meeting the compendial requirements and with an accurate thermometer in the refrigerator if refrigerated drugs will be stored. _____ A freezer meeting the compendia requirements and with an accurate thermometer in the freezer if frozen drugs will be stored. _____ Technical equipment necessary for the appropriate compounding and dispensing the pharmacy conducts. _____ Professional reference library is located in the prescription drug outlet or available electronically. If an electronic library is provided, workstations must be provided in a compounding/dispensing area and must be readily available for use by staff, interns, and Board personnel. The library shall contain, as a minimum: •
Title 12, Article 42.5, Parts 1 through 4 of the Pharmacists, Pharmacy Business, and Pharmaceuticals Act, C.R.S.
•
Title 18, Article 18, the Uniform Controlled Substances Act of 1992, C.R.S.
•
The current rules and regulations of the Colorado Board of Pharmacy
•
The current edition of 21 Code of Federal Regulations (“CFR”) Part 1300 to End containing Drug Enforcement Administration rules relating to controlled substances
NOTE: The pharmacy laws, the state controlled substances act, and the Board’s regulations will be distributed by the inspector at the time of inspection for a new pharmacy.
I HEREBY ATTEST that I have complied with the above requirements.
Date
Signature of Pharmacist Manager
GO TO THE NEXT PAGE
Minimum Equipment Self-Inspection
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SECURITY Rule 5.01.50 provides that every compounding/dispensing area shall comply with the following provisions:
If an employee occupies any compounding/dispensing area, a pharmacist must be physically present on the premises.
If a pharmacist is on the premises but absent from a compounding/dispensing area, it is the responsibility of the pharmacist to ensure the proper safeguard of all drugs.
If other people are in the building when there is NOT a pharmacist present, every compounding/dispensing area must be enclosed by a barrier. The enclosure and barrier must be a secure floor-to-ceiling physical barrier in which any openings shall not be large enough to permit removal of items from the compounding/dispensing area, and it must be of weight and strength sufficient to prevent it from being readily lifted, removed, penetrated or bent. APPLICANT MUST RESPOND TO THE FOLLOWING FOUR ITEMS: 1. Other people may or will be in the building when there is NOT a pharmacist present.
YES
NO
YES
NO
YES
NO
2. If the response to #1 is YES:
Every compounding/dispensing area is enclosed by a barrier as provided herein.
3. If the response to #2 is YES, then all entrances to every compounding/dispensing area shall be secured from unauthorized entry when the pharmacist leaves the building. Once secured, no one other than a pharmacist is permitted to enter any compounding/dispensing area except in extreme emergency, which is defined as a threat to property, public disaster, or other catastrophe.
Every compounding/dispensing area complies with the physical security requirements.
4. The hours of business of the compounding/dispensing area shall be submitted to the Board in writing. The hours are as follows: (APPLICANT MUST ENTER THIS INFORMATION) Monday: Tuesday: Wednesday: Thursday:
Friday: Saturday: Sunday:
While the compounding/dispensing area is closed and the rest of the establishment is open, a person on duty in the establishment shall be able to contact a pharmacist in case of emergency.
I HEREBY ATTEST that I have complied with the above requirements.
Date
Signature of Pharmacist Manager
IF THIS PHARMACY WILL PREPARE STERILE PRODUCTS, GO TO THE NEXT PAGE Minimum Equipment Self-Inspection
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General Requirements for Prescription Drug Outlets that Compound Sterile Products: Minimum requirements _____ The prescription drug outlet shall have a designated area for a laminar flow hood, or it shall have a class 100 room as required by General Services Administration federal standard 209(b) as amended, for the preparation of sterile products. The clean room shall: • • • •
Be designed to avoid outside traffic and air flow; Have non-porous and cleanable surfaces, walls and floors; Be ventilated in a manner not interfering with laminar flow conditions; and Not be used for bulk storage for supplies and materials.
Please specify:
Hood
- OR -
Clean Room
Equipment _____ A laminar flow hood, or clean room as required by General Services Administration federal standard 209(b) as amended, and certified yearly. _____ A refrigerator, the temperature of which is within limits as stated in the current edition of the United States Pharmacopeia. The temperature shall be monitored and recorded each business day. _____ Supplies necessary for sterile product compounding. A prescription drug outlet involved only in compounding sterile products may request a waiver of 5.01.31(e) (see page 2). Check here if you are requesting a waiver and attach request.
Current references. In addition to those required in regulation 5.01.32, the following are required: Guide to Parenteral Admixtures Handbook of Injectable Drugs
or
_____ Please specify which you have and indicate edition number and publication date:
_____ Technical Manual Section VI: Chapter 2, Controlling Occupational Exposure to Hazardous Drugs or ASHP Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs if cytotoxic products are compounded. Policy and Procedure Manual: _____ A policy and procedure manual as it relates to sterile products shall be available for inspection. The manual shall include policies and procedures for: Security Sanitation Drug Storage Drug Delivery
Drug Labeling Drug Destruction and Returns Recordkeeping Recall Procedure
Duties of the Staff Sterile Compounding Techniques Patient Training
_____ If your manual is not set up in this order, the manual must contain a cross-reference guide indicating where the above topics are located. I HEREBY ATTEST that I have complied with the above requirements. Name of Pharmacy: Address:
Date Minimum Equipment Self-Inspection
Signature of Pharmacist Manager Page 4 of 4
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