Which activities count as manufacturing coincident to research
What the document says“``(A) processing the substance to create extracts, tinctures, oils, solutions, derivatives, or other forms of the substance consistent with-- ``(i) the information provided as part of a notification submitted to the Attorney General under section 303(n); or ``(ii) a research protocol filed with an application for registration approval under section 303(g); and ``(B) dosage form development studies performed for the purpose of requesting an investigational new drug exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)).”
The activities the paragraph above permits include processing the substance into extracts, tinctures, oils, solutions, derivatives or other forms, so long as that is consistent with the notification or research protocol on file, and dosage form development studies performed to request an investigational new drug exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act.
What the document actually says“``(A) processing the substance to create extracts, tinctures, oils, solutions, derivatives, or other forms of the substance consistent with-- ``(i) the information provided as part of a notification submitted to the Attorney General under section 303(n); or ``(ii) a research protocol filed with an application for registration approval under section 303(g); and ``(B) dosage form development studies performed for the purpose of requesting an investigational new drug exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)).”
The work can turn the drug into other forms, such as an oil or a liquid. It must match the papers already on file. The work can also test doses for a new medicine.
This is a list of what counts. It is not the whole list. Other small batch work can count too.
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