N.J. Admin. Code § 13:39-7.5

Current through Register Vol. 56, No. 24, December 18, 2024

Section 13:39-7.5 - Approval of FDA necessary

(a) No drug or medicine other than a compounded prescription order, consistent with (c) below, shall be sold or dispensed in any pharmacy within the State of New Jersey until such drug or medicine has received New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Investigational New Drug Application (INDA) or other Federal Food and Drug Administration (FDA) approval, where required.

(b) The storage, labeling, and dispensing of all Investigational New Drugs shall be a pharmaceutical service provided in cooperation with, and in support of the principal investigator. Under these parameters the dispensing of such drugs shall not be construed to be a violation of (a) above. A pharmacy participating in experimental research shall comply with Federal Department of Health and Human Services regulations set forth at 45 CFR Part 46, Protection of Human Subjects of Research, incorporated by reference herein, as amended and supplemented and with the Rowan University Guidance on Human Subjects Research, which is incorporated herein by reference, as amended and supplemented, and which is available at http://www.rowan.edu/som/hsp/guidance/index.html.

(c) No pharmacy or pharmacist shall compound products prohibited by the FDA or use ingredients that are restricted by the FDA.

N.J. Admin. Code § 13:39-7.5

Amended by 49 N.J.R. 3761(a), effective 12/4/2017