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Food & Drug Protection Division

Drug Program

Registration and Licensing

Registration and licensing activities involve prescription drug manufacturers, virtual manufactures, outsourcing facilities (Sterile 503B), re-packagers, medical gas manufactures, medical gas re-packagers, distributors, reverse distributors, wholesalers, third party logistic provider only and pseudoephedrine only. 

 

 

Notice of Federal Background Check Required

The North Carolina Department of Agriculture and Consumer Services, Food and Drug Protection Division, requires applicants of Wholesale Prescription Drug Distributors to obtain and submit a federal background check report with the license application. The Food and Drug Protection Division will consider the following factors when reviewing any criminal convictions:

(1) The level and seriousness of the crime;

(2) The date of the crime;

(3) The age of the applicant at the time of the crime;

(4) The circumstances surrounding the commission of the crime, if known;

(5) The nexus between the criminal conduct and the prospective duties of the applicant as a licensee;

(6) The prison, jail, probation, parole, rehabilitation, and employment records of the applicant since the date the crime was committed;

(6a) The completion of, or active participation in, rehabilitative drug or alcohol treatment;

(6b) A Certificate of Relief granted pursuant to N.C. Gen. Stat. § 15A-173.2;

(7) The subsequent commission of a crime by the applicant; and

(8) Any affidavits or other written documents, including character references.

If the Food and Drug Protection Division denies a license application based on a criminal conviction, the applicant may appeal the denial in accordance with the North Carolina Administrative Procedures Act, N.C. Gen. Stat. § 150B-1 et seq. The applicant may commence the denial by filing a petition for a contested case hearing with the North Carolina Office of Administrative Hearings (OAH) within sixty (60) days at:

Office of Administrative Hearings

6714 Mail Service Center

Raleigh, NC 27699-6700

The petition must be in writing and in the form prescribed by N.C. Gen. Stat. § 150B-23 and accompanied by a filing fee established by OAH. The applicant must also serve a copy of the petition for a contested case hearing to:

Ms. Tina L. Hlabse

North Carolina Department of Agriculture and Consumer Services

Registered Agent and General Counsel

1001 Mail Service Center

Raleigh, NC 27699-1001

Any questions about filing a petition may be directed to the North Carolina Office of Administrative Hearings by telephone at (919) 431-3000. Information may also be obtained online at https://www.oah.nc.gov/hearings-division.


 

 

 

 

 

NCDA&CS Food & Drug Protection Division, Jeremy Evans, Drug Administrator
Mailing Address: 1070 Mail Service Center, Raleigh NC 27699-1070
Physical Address: 4000 Reedy Creek Road, Raleigh NC 27607-6465
Phone: (919) 733-7366; FAX: (919) 733-6801



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