North Dakota Century Code Title 43. Occupations and Professions § 43-15.3-13. Compounding provided by an outsourcing facility

1. A facility may provide, without a patient specific prescription, a nonpatient specific compounded drug preparation for human use only, if the following conditions apply:

2. Within forty-eight hours of a request from the board, the facility shall make available to the board any inspection reports, federal food and drug administration reports of objectionable conditions issued against the facility, and lists of distribution of products to the state.

3. The facility shall comply with all labeling and recordkeeping requirements pursuant to section 503(b) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 353(b)].

4. Notwithstanding contrary provisions of this chapter, an outsourcing facility may compound and sell in the state a compounded calcium gluconate product intended for the emergency treatment of hydrofluoric acid exposure without obtaining a license under this chapter.