This part changes how people sign up to do research with the strictest drugs. Some work can start 30 days after a notice. New researchers get an answer in 45 days. One sign-up can cover a whole team, and can cover more than one site in a town. A second drug in the same class needs no new visit. Work can go on when a drug is newly listed. Small batches can be made for the work itself, but not grown marihuana. The Attorney General must post any special rules for a drug.
The document says “can”Who acts: practitioners conducting researchHow: statuteSec. 3 in the PDF
What the document says
“``(1) In general.--Notwithstanding subsection (g), a practitioner may conduct research described in paragraph (2) of this subsection with 1 or more schedule I substances in accordance with subparagraph (A) or (B) of paragraph (3) of this subsection.”
The opening of a new subsection (n) added to section 303 of the Controlled Substances Act (21 U.S.C. 823). A practitioner may conduct the research described in paragraph (2) with one or more schedule I substances by following either of the two routes in paragraph (3), rather than the route in subsection (g) of that section. What subsection (g) provides is in the amended statute, which is not indexed here.
What the document actually says
“``(1) In general.--Notwithstanding subsection (g), a practitioner may conduct research described in paragraph (2) of this subsection with 1 or more schedule I substances in accordance with subparagraph (A) or (B) of paragraph (3) of this subsection.”
That sentence, in plain words
A researcher can do some work with the strictest drugs. They must follow one of two routes set out below. Those routes come in place of the older one.
What this is about
Schedule I is the strictest list in drug law. Work with those drugs needs the say-so of the government. This adds a faster way to get it.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
The document says “means”Who acts: CongressHow: statuteSec. 3 in the PDF
What the document says
“``(2) Research subject to expedited procedures.--Research described in this paragraph is research that-- ``(A) is with respect to a drug that is the subject of an investigational use exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)); or ``(B) is-- ``(i) conducted by the Department of Health and Human Services, the Department of Defense, or the Department of Veterans Affairs; or”
The research that qualifies for the new subsection. It is research on a drug that is the subject of an investigational use exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act, or research conducted by the Department of Health and Human Services, the Department of Defense or the Department of Veterans Affairs. Clause (ii), not quoted here, adds research funded partly or entirely by a grant, contract, cooperative agreement or other transaction from one of those three departments.
What the document actually says
“``(2) Research subject to expedited procedures.--Research described in this paragraph is research that-- ``(A) is with respect to a drug that is the subject of an investigational use exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)); or ``(B) is-- ``(i) conducted by the Department of Health and Human Services, the Department of Defense, or the Department of Veterans Affairs; or”
That sentence, in plain words
Only some work counts here. It counts if the drug is being tested as a new medicine. It also counts if one of three federal departments does the work.
What this is about
The three are Health and Human Services, Defense, and Veterans Affairs. Work they pay for counts too. Other work must use the older route.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
The document says “can”Who acts: practitioners conducting researchHow: statuteSec. 3 in the PDF
What the document says
“``(i) In general.--If a practitioner is registered to conduct research with a controlled substance in schedule I or II, the practitioner may conduct research under this subsection on and after the date that is 30 days after the date on which the practitioner sends a notice to the Attorney General containing the following information, with respect to each substance with which the practitioner will conduct the research:”
The first of the two routes. A practitioner already registered to research a schedule I or II substance may begin the research 30 days after sending the Attorney General a notice. For each substance the notice must give the chemical name, the quantity to be used, a demonstration that the research falls in the category described in paragraph (2), and a demonstration that the researcher is authorized to conduct the research under the law of the State where it will take place. The demonstration may be satisfied by identifying the sponsoring agency and supplying the number of the grant, contract, cooperative agreement, other transaction or project, or by supplying the application number and the sponsor of record on an application under section 505(i) of the Federal Food, Drug, and Cosmetic Act.
What the document actually says
“``(i) In general.--If a practitioner is registered to conduct research with a controlled substance in schedule I or II, the practitioner may conduct research under this subsection on and after the date that is 30 days after the date on which the practitioner sends a notice to the Attorney General containing the following information, with respect to each substance with which the practitioner will conduct the research:”
That sentence, in plain words
Some researchers are already signed up for these drugs. They send a notice with facts about the work. Thirty days later they can start.
What this is about
The notice goes to the Attorney General. It names the drug and how much is needed. It shows the work is of the right kind. It shows the State allows the work.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
The document says “shall”Who acts: Secretary of Health and Human Services, the Department of Defense, Secretary of Veterans AffairsHow: statuteSec. 3 in the PDF
What the document says
“``(ii) Verification of information by hhs or va.--Upon request from the Attorney General, the Secretary of Health and Human Services, the Department of Defense, or the Secretary of Veterans Affairs, as appropriate, shall verify information submitted by an applicant under clause (i)(III).”
Where the Attorney General asks, the Secretary of Health and Human Services, the Department of Defense or the Secretary of Veterans Affairs, whichever is the right one, must verify what an applicant said to show the research falls in the category described in paragraph (2).
What the document actually says
“``(ii) Verification of information by hhs or va.--Upon request from the Attorney General, the Secretary of Health and Human Services, the Department of Defense, or the Secretary of Veterans Affairs, as appropriate, shall verify information submitted by an applicant under clause (i)(III).”
That sentence, in plain words
The Attorney General can ask a department to check the facts. The department must then check them.
What this is about
The facts are the ones in the notice. They show who pays for the work. The department that pays is the one that checks.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
The document says “shall”Who acts: Attorney GeneralHow: statuteSec. 3 in the PDF
What the document says
“``(ii) Attorney general action.--The Attorney General shall-- ``(I) treat notice received under clause (i) as a sufficient application for a research registration; and ``(II) not later than 45 days of receiving such a notice that contains all information required under subparagraph (A)(i)-- ``(aa) register the applicant; or ``(bb) serve an order to show cause upon the applicant in accordance with section 304(c).”
The second of the two routes. Clause (i) lets a practitioner who is not registered to research a schedule I or II substance send the Attorney General the same notice. The Attorney General must treat that notice as a sufficient application, and within 45 days of a complete notice must either register the applicant or serve an order to show cause under section 304(c) of the Controlled Substances Act. What that section provides is in the amended statute, which is not indexed here.
What the document actually says
“``(ii) Attorney general action.--The Attorney General shall-- ``(I) treat notice received under clause (i) as a sufficient application for a research registration; and ``(II) not later than 45 days of receiving such a notice that contains all information required under subparagraph (A)(i)-- ``(aa) register the applicant; or ``(bb) serve an order to show cause upon the applicant in accordance with section 304(c).”
That sentence, in plain words
A notice from a new researcher counts as an application. The Attorney General has 45 days to act on it. They either sign the person up or send a notice to explain why not.
What this is about
This route is for people not yet signed up for these drugs. They send the same facts as anyone else. Unlike the first route, they must wait for an answer.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
The document says “shall”Who acts: Attorney GeneralHow: statuteSec. 3 in the PDF
What the document says
“``(4) Electronic submissions.--The Attorney General shall provide a means to permit a practitioner to submit a notification under paragraph (3) electronically.”
The Attorney General must provide a way for a practitioner to file a notification under paragraph (3), by either route, in electronic form.
What the document actually says
“``(4) Electronic submissions.--The Attorney General shall provide a means to permit a practitioner to submit a notification under paragraph (3) electronically.”
That sentence, in plain words
The Attorney General must set up a way to file online. Researchers use it to send the notice.
What this is about
The notice starts the work under this rule. The law does not say what the online path must look like. It says that one must exist.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
The document says “may not”Who acts: practitioners conducting researchHow: statuteSec. 3 in the PDF
What the document says
“``(5) Limitation on amounts.--A practitioner conducting research with a schedule I substance under this subsection may only possess the amounts of schedule I substance identified in-- ``(A) the notification to the Attorney General under paragraph (3); or ``(B) a supplemental notification that the practitioner may send if the practitioner needs additional amounts for the research,”
A practitioner working under the new subsection may possess only the amounts identified in the notification, or in a supplemental notification sent when more is needed. The supplemental notification must include the name of the practitioner, the additional quantity needed and an attestation that the research to be conducted with the substance is consistent with the scope of the research covered by the first notification.
What the document actually says
“``(5) Limitation on amounts.--A practitioner conducting research with a schedule I substance under this subsection may only possess the amounts of schedule I substance identified in-- ``(A) the notification to the Attorney General under paragraph (3); or ``(B) a supplemental notification that the practitioner may send if the practitioner needs additional amounts for the research,”
That sentence, in plain words
A researcher can hold only what the notice named. If they need more, they send a second notice. That notice covers the extra amount.
What this is about
The first notice names a quantity. That number sets the cap. The second notice must show the extra is for the same work.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
The document says “shall not”Who acts: CongressHow: statuteSec. 3 in the PDF
What the document says
“``(6) Importation and exportation requirements not affected.--Nothing in this subsection alters the requirements of part A of title III, regarding the importation and exportation of controlled substances.”
A savings clause. The new subsection leaves the requirements of part A of title III, on the importation and exportation of controlled substances, as they stand. Those requirements are in the amended statute, which is not indexed here.
What the document actually says
“``(6) Importation and exportation requirements not affected.--Nothing in this subsection alters the requirements of part A of title III, regarding the importation and exportation of controlled substances.”
That sentence, in plain words
This rule does not touch the rules on bringing drugs in or sending them out. Those rules stay as they are.
What this is about
A researcher may get a drug from abroad. The older rules still cover that step. The faster route here does not change them.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
The document says “shall”Who acts: the Inspector General of the Department of JusticeHow: statuteSec. 3 in the PDF
What the document says
“``(7) Inspector general report.--Not later than 1 year after the date of enactment of the Halt All Lethal Trafficking of Fentanyl Act, the Inspector General of the Department of Justice shall complete a study, and submit to Congress a report thereon, about research described in paragraph (2) of this subsection with fentanyl.''.”
Within one year of the Act's enactment on July 16, 2025, the Inspector General of the Department of Justice must complete a study of research with fentanyl of the kind described in paragraph (2), and report on it to Congress.
What the document actually says
“``(7) Inspector general report.--Not later than 1 year after the date of enactment of the Halt All Lethal Trafficking of Fentanyl Act, the Inspector General of the Department of Justice shall complete a study, and submit to Congress a report thereon, about research described in paragraph (2) of this subsection with fentanyl.''.”
That sentence, in plain words
A watchdog at the Justice Department must study this work. The study covers research with fentanyl. It must be done within a year.
What this is about
The watchdog then sends a report to Congress. The law does not say what the report must find. It only says the study must happen.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
The document says “is amended”Who acts: CongressHow: statuteSec. 3 in the PDF
What the document says
“``(4) An agent or employee of a research institution that is conducting research with a controlled substance if-- ``(A) the agent or employee is acting within the scope of the professional practice of the agent or employee; ``(B) another agent or employee of the institution is registered to conduct research with a controlled substance in the same schedule;”
A paragraph (4) added at the end of section 302(c) of the Controlled Substances Act (21 U.S.C. 822(c)). It covers an agent or employee of a research institution conducting research with a controlled substance, where that person is acting within the scope of their professional practice and another agent or employee of the institution is registered for a substance in the same schedule. Two further conditions, in subparagraphs (C) and (D), are recorded below.
What the document actually says
“``(4) An agent or employee of a research institution that is conducting research with a controlled substance if-- ``(A) the agent or employee is acting within the scope of the professional practice of the agent or employee; ``(B) another agent or employee of the institution is registered to conduct research with a controlled substance in the same schedule;”
That sentence, in plain words
One team member is signed up for the drug. Another team member then does not have to sign up. That second person must be doing their normal job.
What this is about
The two must work at the same research body. The drug must be on the same list as the one in the sign-up. Two more conditions come next.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
The document says “shall”Who acts: registered researchersHow: statuteSec. 3 in the PDF
What the document says
“``(iii) affirms that any act taken by that agent or employee involving a controlled substance shall be attributable to the registered researcher, as if the researcher had directly committed the act, for purposes of any proceeding under section 304(a) to suspend or revoke the registration of the registered researcher; and”
The third condition in subparagraph (C). The registered researcher must also inform the Attorney General of the name, position title and employing institution of the agent or employee who is not separately registered, and authorize that person to perform research under the registration. The clause quoted adds that the researcher affirms that the other person's acts count as the researcher's own in a proceeding under section 304(a) of the Controlled Substances Act to suspend or revoke the registration.
What the document actually says
“``(iii) affirms that any act taken by that agent or employee involving a controlled substance shall be attributable to the registered researcher, as if the researcher had directly committed the act, for purposes of any proceeding under section 304(a) to suspend or revoke the registration of the registered researcher; and”
That sentence, in plain words
What the second person does counts as the first person's act. That matters if the sign-up is called into question. It is treated as if the first person did it.
What this is about
The first researcher must also name the second to the Attorney General. They must say the second may work under their sign-up. In return they carry the risk.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
The document says “can”Who acts: Attorney GeneralHow: statuteSec. 3 in the PDF
What the document says
“``(D) the Attorney General does not, within 30 days of receiving the information, authorization, and affirmation described in subparagraph (C), refuse, for a reason listed in section 304(a), to allow the agent or employee to possess the substance without a separate registration.''.”
The last condition. The exemption holds only if the Attorney General does not refuse it within 30 days of receiving the information, authorization and affirmation, and any refusal must rest on a reason listed in section 304(a) of the Controlled Substances Act. What those reasons are is in the amended statute, which is not indexed here.
What the document actually says
“``(D) the Attorney General does not, within 30 days of receiving the information, authorization, and affirmation described in subparagraph (C), refuse, for a reason listed in section 304(a), to allow the agent or employee to possess the substance without a separate registration.''.”
That sentence, in plain words
The Attorney General has 30 days to say no. A no must rest on a reason set out in the older law. If no answer comes, the second person may hold the drug.
What this is about
The clock starts when the papers arrive. The papers are the ones the first researcher sends. Silence means the exemption holds.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
The document says “can”Who acts: persons registered to conduct researchHow: statuteSec. 3 in the PDF
What the document says
“``(4)(A) Notwithstanding paragraph (1), a person registered to conduct research with a controlled substance under section 303(g) may conduct the research under a single registration if-- ``(i) the research occurs exclusively on sites all of which are-- ``(I) within the same city or county; and ``(II) under the control of the same institution, organization, or agency; and”
A paragraph (4) added at the end of section 302(e) of the Controlled Substances Act (21 U.S.C. 822(e)). A person registered under section 303(g) may work under a single registration where every site is in the same city or county and under the control of the same institution, organization or agency, and where, under clause (ii), the researcher notifies the Attorney General before commencing the research of each site where the research will be conducted or the substance stored or administered. Subparagraph (B) adds that a site counts only if it was named in the application for the registration or notified before research, storage or administration there.
What the document actually says
“``(4)(A) Notwithstanding paragraph (1), a person registered to conduct research with a controlled substance under section 303(g) may conduct the research under a single registration if-- ``(i) the research occurs exclusively on sites all of which are-- ``(I) within the same city or county; and ``(II) under the control of the same institution, organization, or agency; and”
That sentence, in plain words
A researcher can use one sign-up for several sites. All the sites must be in the same city or county. They must all be run by the same body.
What this is about
The rule sets aside another rule about places. The researcher must still tell the Attorney General each site. That must happen before work starts there.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
The document says “can”Who acts: Attorney GeneralHow: statuteSec. 3 in the PDF
What the document says
“``(C) The Attorney General may, in consultation with the Secretary, issue regulations addressing, with respect to research sites described in subparagraph (A)-- ``(i) the manner in which controlled substances may be delivered to the research sites; ``(ii) the storage and security of controlled substances at the research sites;”
The Attorney General may, in consultation with the Secretary, issue regulations for sites covered by a single registration. The listed subjects are delivery, storage and security, and, in the two clauses not quoted, the maintenance of records for the sites and any other matters necessary to ensure effective controls against diversion.
What the document actually says
“``(C) The Attorney General may, in consultation with the Secretary, issue regulations addressing, with respect to research sites described in subparagraph (A)-- ``(i) the manner in which controlled substances may be delivered to the research sites; ``(ii) the storage and security of controlled substances at the research sites;”
That sentence, in plain words
The Attorney General can write rules for these sites. The rules can cover how a drug gets there. They can cover how it is kept safe.
What this is about
Rules like these fill in the details of a law. This one is a choice, not a duty. The Secretary of Health and Human Services is asked first.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
The document says “is amended”Who acts: CongressHow: statuteSec. 3 in the PDF
What the document says
“``(2)(A) If a person is registered to conduct research with a controlled substance and applies for a registration, or for a modification of a registration, to conduct research with a second controlled substance that is in the same schedule as the first controlled substance, or is in a schedule with a higher numerical designation than the schedule of the first controlled substance, a new inspection by the Attorney General of the registered location is not required.”
A paragraph added at the end of section 302(f) of the Controlled Substances Act (21 U.S.C. 822(f)). Where a registered researcher applies to add a second substance in the same schedule as the first, or in a schedule with a higher number, no new inspection of the registered location is required.
What the document actually says
“``(2)(A) If a person is registered to conduct research with a controlled substance and applies for a registration, or for a modification of a registration, to conduct research with a second controlled substance that is in the same schedule as the first controlled substance, or is in a schedule with a higher numerical designation than the schedule of the first controlled substance, a new inspection by the Attorney General of the registered location is not required.”
That sentence, in plain words
A researcher is signed up for one drug. They ask to add a second drug on the same list or a lower one. The site does not have to be checked again.
What this is about
Schedule I is the first list. A higher number means a later list. The rule saves a second check of the same place.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
The document says “shall not”Who acts: Attorney GeneralHow: statuteSec. 3 in the PDF
What the document says
“``(B) Nothing in subparagraph (A) shall prohibit the Attorney General from conducting an inspection that the Attorney General determines necessary to ensure that a registrant maintains effective controls against diversion.''.”
The paragraph above does not stop the Attorney General from inspecting where the Attorney General determines an inspection is necessary to ensure that a registrant maintains effective controls against diversion.
What the document actually says
“``(B) Nothing in subparagraph (A) shall prohibit the Attorney General from conducting an inspection that the Attorney General determines necessary to ensure that a registrant maintains effective controls against diversion.''.”
That sentence, in plain words
The Attorney General can still check a site. That happens when a check is thought to be needed. The point is to stop drugs going astray.
What this is about
The rule before this one drops a required check. It does not take away the power to check. The choice stays with the Attorney General.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
The document says “shall”Who acts: persons registered to conduct researchHow: statuteSec. 3 in the PDF
What the document says
“If a person is conducting research on a substance when the substance is added to schedule I, and the person is already registered to conduct research with a controlled substance in schedule I-- ``(1) not later than 90 days after the scheduling of the newly scheduled substance, the person shall submit a completed application for registration or modification of existing registration, to conduct research on the substance, in accordance with regulations issued by the Attorney General for purposes of this paragraph;”
The opening of a new subsection (h) added at the end of section 302 of the Controlled Substances Act (21 U.S.C. 822). Where a substance a person is already researching is added to schedule I, and that person is already registered for a schedule I substance, they must apply within 90 days for registration or for a modification of an existing registration covering the substance.
What the document actually says
“If a person is conducting research on a substance when the substance is added to schedule I, and the person is already registered to conduct research with a controlled substance in schedule I-- ``(1) not later than 90 days after the scheduling of the newly scheduled substance, the person shall submit a completed application for registration or modification of existing registration, to conduct research on the substance, in accordance with regulations issued by the Attorney General for purposes of this paragraph;”
That sentence, in plain words
A drug can be added to the strictest list while work on it goes on. The researcher then has 90 days to file papers. The papers ask to keep working with it.
What this is about
This law adds a whole group of drugs to that list at once. Some of them were being studied already. This rule is about that gap.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
The document says “can”Who acts: persons registered to conduct researchHow: statuteSec. 3 in the PDF
What the document says
“``(2) the person may, notwithstanding subsections (a) and (b), continue to conduct the research on the substance until-- ``(A) the person withdraws the application described in paragraph (1) of this subsection; or ``(B) the Attorney General serves on the person an order to show cause proposing the denial of the application under section 304(c);”
While the application is pending the person may keep conducting the research, whatever subsections (a) and (b) of section 302 require, until they withdraw the application or the Attorney General serves an order to show cause proposing to deny it under section 304(c) of the Controlled Substances Act.
What the document actually says
“``(2) the person may, notwithstanding subsections (a) and (b), continue to conduct the research on the substance until-- ``(A) the person withdraws the application described in paragraph (1) of this subsection; or ``(B) the Attorney General serves on the person an order to show cause proposing the denial of the application under section 304(c);”
That sentence, in plain words
The work does not have to stop while the papers are read. It goes on until the researcher drops the request. It also stops if the Attorney General moves to say no.
What this is about
An order to show cause is a notice. It says the request may be turned down. It gives the researcher a chance to answer.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
The document says “shall”Who acts: Attorney GeneralHow: statuteSec. 3 in the PDF
What the document says
“``(3) if the Attorney General serves an order to show cause as described in paragraph (2)(B) and the person requests a hearing, the hearing shall be held on an expedited basis and not later than 45 days after the request is made, except that the hearing may be held at a later time if so requested by the person; and”
Where an order to show cause is served and the person asks for a hearing, the hearing must be held on an expedited basis and no later than 45 days after the request, unless the person asks for a later date.
What the document actually says
“``(3) if the Attorney General serves an order to show cause as described in paragraph (2)(B) and the person requests a hearing, the hearing shall be held on an expedited basis and not later than 45 days after the request is made, except that the hearing may be held at a later time if so requested by the person; and”
That sentence, in plain words
The researcher can ask for a hearing. It must be held within 45 days. It can be later only if the researcher asks for that.
What this is about
A hearing is a chance to make the case. The clock here is short. That keeps the work from being held up for long.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
The document says “shall”Who acts: CongressHow: statuteSec. 3 in the PDF
What the document says
“``(4) if the person sends a copy of the application described in paragraph (1) to a manufacturer or distributor of the substance, receipt of the copy by the manufacturer or distributor shall constitute sufficient evidence that the person is authorized to receive the substance.''.”
Where the person sends a copy of the application to a manufacturer or distributor of the substance, receipt of that copy counts as sufficient evidence that the person is authorized to receive it.
What the document actually says
“``(4) if the person sends a copy of the application described in paragraph (1) to a manufacturer or distributor of the substance, receipt of the copy by the manufacturer or distributor shall constitute sufficient evidence that the person is authorized to receive the substance.''.”
That sentence, in plain words
The researcher can send a copy of the papers to a supplier. Getting that copy is proof enough for the supplier. It shows the researcher may take the drug.
What this is about
The papers are not yet approved at this stage. The rule says the copy counts as proof. The supplier can then hand over the drug.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
The document says “can”Who acts: persons registered to conduct researchHow: statuteSec. 3 in the PDF
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”
That sentence, in plain words
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.
What this is about
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.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
The document says “means”Who acts: CongressHow: statuteSec. 3 in the PDF
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)).”
That sentence, in plain words
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.
What this is about
This is a list of what counts. It is not the whole list. Other small batch work can count too.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
The document says “may not”Who acts: persons registered to conduct researchHow: statuteSec. 3 in the PDF
What the document says
“``(3) Exception regarding marihuana.--The authority under paragraph (1) to manufacture substances does not include the authority to grow marihuana.''.”
The one exception to the manufacturing permission. It does not extend to growing marihuana. The Act spells the word as the Controlled Substances Act spells it.
What the document actually says
“``(3) Exception regarding marihuana.--The authority under paragraph (1) to manufacture substances does not include the authority to grow marihuana.''.”
That sentence, in plain words
This rule does not let a researcher grow marihuana. That is left out on purpose.
What this is about
The rule before this one covers making small batches. Growing a plant is not part of it. A researcher who wants to grow must look elsewhere.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
The document says “shall”Who acts: Attorney GeneralHow: statuteSec. 3 in the PDF
What the document says
“``(1) In general.--If the Attorney General determines, with respect to a controlled substance, that an application by a practitioner to conduct research with the substance should be considered under a process, or subject to criteria, different from the process or criteria applicable to applications to conduct research with other controlled substances in the same schedule, the Attorney General shall make public, including by posting on the website of the Drug Enforcement Administration--”
A new subsection (o) added at the end of section 303 of the Controlled Substances Act (21 U.S.C. 823). Where the Attorney General decides that research applications for a substance go through a different process, or meet different criteria, from those for other substances in the same schedule, the Attorney General must make that public, including on the website of the Drug Enforcement Administration. The three items to be published are the identities of all substances for which such a determination has been made, the process and criteria that apply to them, and how those differ from the process and criteria for other substances in the same schedule.
What the document actually says
“``(1) In general.--If the Attorney General determines, with respect to a controlled substance, that an application by a practitioner to conduct research with the substance should be considered under a process, or subject to criteria, different from the process or criteria applicable to applications to conduct research with other controlled substances in the same schedule, the Attorney General shall make public, including by posting on the website of the Drug Enforcement Administration--”
That sentence, in plain words
One drug can have its own rules for research requests. If the Attorney General sets those rules, they must be posted. The DEA website is one place they go.
What this is about
The DEA is the drug agency of the Justice Department. Three things must be posted. They are the drugs, the special rules, and how those rules differ.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
The document says “shall”Who acts: Attorney GeneralHow: statuteSec. 3 in the PDF
What the document says
“``(2) Timing of posting.--The Attorney General shall make information described in paragraph (1) public upon making a determination described in that paragraph, regardless of whether a practitioner has submitted such an application at that time.''.”
The information must be published as soon as the determination is made, whether or not any practitioner has applied to research the substance by then.
What the document actually says
“``(2) Timing of posting.--The Attorney General shall make information described in paragraph (1) public upon making a determination described in that paragraph, regardless of whether a practitioner has submitted such an application at that time.''.”
That sentence, in plain words
The facts go up as soon as the choice is made. It does not matter if nobody has asked to do the research yet.
What this is about
This sets the timing for the rule before it. A researcher can see the rules first. They do not have to file to find out.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
Each distinct thing the section requires or permits, across its seven subsections: the alternative process for schedule I research and the research it covers, the 30 day notice route and the 45 day answer, electronic filing, the cap on amounts held, the savings clause for import and export, the Inspector General study, the exemption for a second researcher in the same institution and its conditions, the single registration for related sites and the regulations that may govern them, the inspection that is not required and the one the Attorney General may still make, the continuation of research on a newly scheduled substance, the manufacturing treated as part of research, and the duty to publish special procedures.
Purely mechanical amendments. The redesignation of the second subsection (l) of section 303 as subsection (m), and the striking of ``(25)'' and insertion of ``(27)'' in section 302(c)(3), change no duty and are noted here rather than recorded as entries of their own.
The section works by amending sections 302 and 303 of the Controlled Substances Act (21 U.S.C. 822 and 823), which are not indexed here, so nothing recorded says what those sections said before this Act or read as now: only the words this Act inserts are recorded. Section 304 of that Act, section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) and part A of title III of the Controlled Substances Import and Export Act are cited and not indexed.
