§ 43-15.3-13 — Compounding provided by an outsourcing facility

North Dakota § 43-15.3-13

• Jurisdiction: North Dakota
• Title 43: Occupations and Professions
• Ch. 43-15.3: Wholesale Drug Pedigree

Text

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:
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.