Document ID: chunk:federal_register_of_legislation:F2020C00810:reg:40
Version: federal_register_of_legislation:F2020C00810
Segment Type: reg
Provision Reference: reg 40
Character Range: 46076–47022

40  Information for active constituents
  If the application relates to an active constituent, the application must contain, or be accompanied by, the following information:
 (a) the name of the relevant chemical product for the active constituent;
 (b) the following names of the constituent:
 (i) the common name;
 (ii) the IUPAC name (if applicable);
 (iii) the chemical abstracts name (if applicable);
 (c) the CAS number of the constituent (if applicable);
 (d) the minimum purity or pharmacopoeial standard of the constituent;
 (e) the following information about the manufacturer of the constituent:
 (i) the manufacturer's name;
 (ii) if the manufacturer has an ACN—the ACN;
 (iii) if the manufacturer is an overseas company and has a number equivalent to an ACN—that number;
 (iv) the name and street address of the site at which the active constituent is manufactured;
 (v) the country in which the active constituent is manufactured.