North Dakota Code 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:
Terms Used In North Dakota Code 43-15.3-13
- following: when used by way of reference to a chapter or other part of a statute means the next preceding or next following chapter or other part. See North Dakota Code 1-01-49
- Person: means an individual, organization, government, political subdivision, or government agency or instrumentality. See North Dakota Code 1-01-49
- State: when applied to the different parts of the United States, includes the District of Columbia and the territories. See North Dakota Code 1-01-49
- United States: includes the District of Columbia and the territories. See North Dakota Code 1-01-49
a. The entity is registered with the United States food and drug administration as an outsourcing facility pursuant to section 503(b) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 353(b)]; and
b. The entity is licensed under this chapter with an outsourcing facility classification, has designated a licensed pharmacist in the state of residence as the responsible person on the license, and the facility meets the standards for licensure set in this chapter.
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.