(a)  The Division of Public Health shall provide vaccines required by law free of charge to the following providers for administration to individuals who need vaccines to meet the requirement of G.S. 130A‑152, 130‑155.1 and 10A NCAC 41A .0401:

(1)           Community, migrant, and rural health centers;

(2)           Colleges and universities for students; and

(3)           Physicians and other health care providers.

(b)  Upon request of the Division, required vaccines may be distributed by local health departments operating as agents of the State to providers listed in Subparagraphs (a)(1), (2) and (3) of this Rule.

(c)  Providers authorized in Paragraph (a) of this Rule shall receive free vaccines from the Division only if they sign an agreement with the Division.  This agreement shall be prepared by the Division of Public Health and shall require the provider to:

(1)           Charge vaccine administration fees at no more than the rates established by the State's Medicaid program.  The State's Medicaid rates may be inspected at the Division of Public Health.  Copies may also be obtained from the Division of Public Health at no charge;

(2)           Provide all vaccines needed during a visit unless a specific contraindication exists to one or more of the vaccine;

(3)           Charge no office fee in addition to an administration fee for an immunization‑only visit;

(4)           Agree not to charge an administration fee to an individual who states that he/she is unable to pay;

(5)           Impose no condition as a prerequisite to receiving vaccine;

(6)           Submit a monthly doses administered report by the tenth of each month electronically through the North Carolina Immunization Registry or on a form provided by the Immunization Section;

(7)           Report adverse vaccine reactions through the Vaccine Adverse Event Reporting System (VAERS);

(8)           Provide the latest edition of the applicable Important Information Statement (IIS), or Vaccine Information Statement (VIS) to the parent, guardian, or person standing in loco parentis for each dose of vaccine administered; document this action within the patient's permanent medical record; retain the documentation for a period of 10 years following the end of the calendar year in which the vaccine dose was administered, or for 10 years following the recipient's age of majority, whichever is longer; upon request, furnish copies of the documentation to the local health department or the Division; and keep a record of the vaccine manufacturer, lot number, and date of administration for each dose of vaccine administered;

(9)           Allow periodic inspection of their vaccine supplies and records by the Division of Public Health; and

(10)         Comply with the rules of this Section.

(d)  A provider who fails to submit timely and accurate reports as required each month shall have vaccine shipments withheld until that month's report is received by the Immunization Section.


History Note:        Authority G.S. 130A-433;

Temporary Rule Eff. October 5, 1986 for a period of 120 days to expire on February 1, 1987;

Temporary Rule Eff. February 1, 1987 for a period of 120 days to expire on May 31, 1987;

Eff. March 1, 1987;

Temporary Amendment Eff. February 1, 1988, for a period of 180 days to expire on July 29, 1988;

Temporary Amendment Eff. August 26, 1992, for a period 180 days or until the permanent rule becomes effective, whichever is sooner;

Temporary Amendment Eff. October 1, 1994, for a period of 180 days or until the permanent rule becomes effective, whichever is sooner;

Amended Eff. October 1, 1995; January 1, 1995; January 4, 1994; January 4, 1993;

Temporary Amendment Eff. December 1, 1998;

Amended Eff. August 1, 2000;

Temporary Amendment Eff. December 1, 2007

Amended Eff. November 1, 2008.