Small scale manufacturing for the research needs no manufacturing registration
What the document says“``(1) In general.--Except as provided in paragraph (3), a person who is registered to perform research on a controlled substance may perform manufacturing activities with small quantities of that substance, including activities described in paragraph (2), without being required to obtain a manufacturing registration, if-- ``(A) the activities are performed for the purpose of the research; and”
The opening of a new subsection (i) added at the end of section 302 of the Controlled Substances Act (21 U.S.C. 822). A person registered to research a substance may carry out manufacturing activities with small quantities of it without a manufacturing registration, where the activities are for the purpose of the research and, under subparagraph (B), the activities and the quantities involved are stated in a notification under section 303(n), in a research protocol filed with an application under section 303(g), or in a notification giving the registrant's name and an attestation that the research is consistent with the scope of the research the registration rests on.
What the document actually says“``(1) In general.--Except as provided in paragraph (3), a person who is registered to perform research on a controlled substance may perform manufacturing activities with small quantities of that substance, including activities described in paragraph (2), without being required to obtain a manufacturing registration, if-- ``(A) the activities are performed for the purpose of the research; and”
A researcher can make small batches of the drug they study. They do not need a second sign-up to do it. The work must be for the research itself.
Making a drug needs its own sign-up as a rule. A researcher can skip that for small batches. They must state the work and the amount first.
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