SOUTH DAKOTA STATE BOARD OF PHARMACY

SOUTH DAKOTA BOARD OF PHARMACY

4001 W. Valhalla Blvd, STE 106, Sioux Falls, 57106

Phone: (605) 362-2737 Fax: (605) 362-2738 pharmacy.

Wholesale Distributors Reverse Distributors Other Drug Distributors

LICENSE APPLICATION INSTRUCTIONS FOR:

Manufacturing Distributors

Distribution Centers

Virtual Manufacturers

503B Outsourcing Facilities

Third Party Logistics Providers (License required for South Dakota 3PLs only)

At this time, all Initial/New and Change of Ownership applications must be completed using a paper application All renewal applications must be completed using the new online licensing platform ()

License renewal period Nov 1 to Dec 31 All licenses expire Dec 31 each year; there is no grace period For current statues/rules go to SDCL 36-11 and ARSD 20:67 () Incomplete applications will be returned to sender

Remember to:

? Use the current application form () ? Submit payment, application, and all documents together ? Allow 14 business days for application processing once received ? Update your records and shipping software to reflect Board's address above

Application Checklist - the following are required for licensure

Completed, signed application form with all required documentation.

Renewal fees: $250 (for all Wholesale or other Drug Distributors), $200 (for 503B Outsourcing Facilities) Check/money payable to SD Board of Pharmacy; a check aged 120 days cannot be deposited.

Copy of the firm's (license/permit/registration certificate) issued by the home state regulatory authority OR a letter from that authority certifying the firm's compliance with all home state laws.

Copy of (1) most recent home state regulatory inspection report (conducted within the last 4 years) and deficiency correction documentation or (2) current VAWD (conducted within the last 4 years) or (3) current FDA inspection report and deficiency correction documentation. If an inspection is not available, provide a written explanation as to why it is not available.

If 503B Outsourcing Facility, FDA inspection and deficiency correction documentation are required.

If Virtual Manufacturer, provide #1, 2, & 3. If Virtual Wholesaler, provide #2. (1) Contract Manufacturer name, address, and copy of agreement first page and signature page only (2) 3PL name, address, copy of agreement first page and signature page only, and proof of VAWD accreditation for 3PL (3) Product/NDC list

Current copy of Federal DEA certificate is required (if handling controlled substances).

Include attachments for any application question(s) you answered as "See Attached".

If a Change of Ownership (CHOW), provide a diagram/listing of previous ownership structure and new ownership structure.

Application Question # 7 SD Controlled Substance Registration If your firm distributes controlled substances into South Dakota, your firm is required to be registered with the SD Department of Health. Go to (), complete a Controlled Substance Registration form and submit to address on form. Do not send form to the Board of Pharmacy.

Application Question # 11 Due Process Service (ARSD 20:67:07:01) Out-of-state firms must designate a resident agent in

SD for process service. For SD registered agent information visit (

forms/commercial-registered-agents.aspx)

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SOUTH DAKOTA BOARD OF PHARMACY

4001 W. Valhalla Blvd, STE 106, Sioux Falls, 57106

Phone: (605) 362-2737 Fax: (605) 362-2738 pharmacy.

WHOLESALE & OTHER DRUG DISTRIBUTORS LICENSE APPLICATION including

Wholesale Distributors Reverse Distributors Other Distributors

Manufacturing Distributors

Distribution Centers

Virtual Manufacturers

503B Outsourcing Facilities

Third Party Logistics Providers (License required for South Dakota 3PLs only)

Application Fee:

$250 (for all Wholesale or other Drug Distributors), $200 (for 503B Outsourcing Facilities) By check / money order payable to SD Board of Pharmacy; checks aged 120 days cannot be deposited

License Type:

New

Change of Ownership For Renewals go to ()

Current SD License # 600 -

1. Legal Name of Business

DBA Name (if applicable)

Responsible Person at Firm

Title:

Address

City

State

ZIP

Email

Phone

Fax

Internet Address

2. Legal Name of Parent Company Headquarters/Corporate Office

Name

Address

City

State

ZIP

Phone

Fax

3. Name and Mailing Address where (license) and all correspondence regarding licensure will be sent if other than licensed facility above

Contact Name

Title

Company Name

Mailing Address

City

State

ZIP

Email

Phone

Fax

4. Type of Distribution (check all that apply)

1. Wholesaler Dist

2. Manufacturing Dist

5. Reverse Dist

6. Virtual Mfr

8. (SD Only) Third Party Logistics Provider

3. Repackager

4. Distribution Center

7. 503B Outsourcing Facility

9. Other

5. Type of Prescription Drugs/Products

1. DEA controlled substances

3. Noncontrolled prescription drugs ("federal legend")

5. Veterinary prescription drugs

6. Medical Gases

2. Ephedrine or pseudoephedrine products 4. Over-the-Counter drugs 7. Other

6. Types of Customers you sell / distribute to

1. Other Wholesalers 4. Practitioners/Clinics

2. Hospitals 5. Patients

3. Pharmacies 6. Other

SD BOP USE ONLY

Received

Approved

Check # Inspect

REVISED 10/2018

_

Amount

_

Issued

7. VAWD Registration ? not required for licensure but recognized

Is this business registered as a Verified Accredited Wholesale/Other Drug Distributor (VAWD) with the National Association of

Boards of Pharmacy?

No Yes If yes, provide VAWD expiration date

8. Home State

Provide the following information for the state in which the facility is located. If not applicable, write NA in blank

State

License #

Expiration Date

DEA #

FDA #

(if applicable)

9. Attach a Copy of the Following Documents to Application

The Home State license or its equivalent if home state is not SD The most recent Home State, FDA, or VAWD inspection report (conducted within the last 4 years) for this facility if home state is not SD. Explain if not available and include deficiency correction documentation Copy of current Federal DEA certificate (if dispensing controlled substances) If 503B Outsourcing Facility, FDA inspection report and deficiency correction documentation are required If Virtual Manufacturer, provide #1, 2, & 3. If Virtual Distributor, provide #2.

(1) Contract Manufacturer name, address, and copy of agreement first page and signature page only (2) 3PL name, address, copy of agreement first page and signature page only, and proof of VAWD accreditation for 3PL (3) Product/NDC list

10. SD Controlled Substance Registration

SD Controlled License #

(if applicable)

If registration is needed, contact the SD Dept. of Health, Attn: Licensure & Certification, 615 E 4th St, Pierre, SD 57501 for information regarding SD controlled substance registration. Phone 605-773-3356 or download application from

11. List all other states where licensed. If none, indicate such.

12. Type of Ownership or Operation

Sole Proprietorship

Partnership

Corporation

Other

13. Owner/Operator of the Facility 1) Sole proprietor - list the name and address of the person; 2) Partnership - list the name of each partner and name

and address of the partnership; 3) Corporation ? list the name and title of each corporate officer, director, or member; the corporate names, name and address of the parent company, if any, and the State of incorporation. Attach additional sheets if necessary.

14. Registered Agent in SD (Name and Address)

For a list of SD registered agents go to ()

15. DISCIPLINARY ACTIONS ? Have any misdemeanor or felony convictions or disciplinary actions (including pending) been taken

against the applicant in the last 7 years?

No

Yes If yes, please list and explain on an attached sheet.

16. Certification

I certify that the applicant will operate in a manner prescribed by federal and state laws and rules adopted by the board. I declare and affirm under the penalties of perjury that this application has been examined by me, and to the best of my knowledge and belief, is in all things true and correct.

Typed Name of Owner or Corporate Officer

Typed Title of Owner or Corporate Officer

Signature of Owner or Corporate Officer

Date

Mail payment, application, and required documentation to South Dakota Board of Pharmacy, 4001 W. Valhalla Blvd, STE 106, Sioux Falls, SD 57106

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