‘‘(j) STATUTE OF LIMITATIONS.— 
‘‘(1) IN GENERAL.—No proceeding for the sus-
pension or revocation of a permit for violation of any 
condition thereof relating to compliance with Federal 
law shall be instituted by the Secretary more than 
18 months after conviction of the violation of Fed-
eral law, or, if no conviction has been had, more 
than 3 years after the violation occurred. 
‘‘(2) COMPROMISE.—No permit shall be sus-
pended or revoked for a violation of any such condi-
tion thereof if the alleged violation of Federal law 
has been compromised by any officer of the Govern-
ment authorized to compromise such violation. 
‘‘(k) PERMIT APPLICATION.— 
‘‘(1) IN GENERAL.—Applications for permits to 
engage in any of the operations set forth in this sec-
tion must be made on the required form. The appli-
cation will include all data, written statements, affi-
davits, documents, or other evidence submitted in 
support of the application, or upon a hearing. 
‘‘(2) CONFIDENTIALITY.—All financial informa-
tion submitted by a permit applicant in connection 
with an application shall be deemed confidential 
business information and exempt from disclosure 
under the Freedom of Information Act. 
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‘‘(3) INCOMPLETE OR INCORRECTLY EXECUTED 
APPLICATIONS.—Incomplete or incorrectly executed 
applications will not be acted upon, but the applicant 
shall be entitled to file a new application without 
prejudice, or to complete the application already 
filed. The Secretary shall notify the applicant of 
such defects in the application within 90 days of ap-
plication or within 10 days of the discovery of the 
defect after the first 30 days following the filing of 
the application. 
‘‘(4) CHANGE
IN
OWNERSHIP, MANAGEMENT, 
OR CONTROL OF THE APPLICANT.—In the event of 
any change in the ownership, management, or con-
trol of the applicant (in case of a corporation, any 
change in the officers, directors, or persons holding 
more than 10 percent of the corporate stock), after 
the date of filing of any application for a permit and 
prior to final action on such application, the appli-
cant shall notify the appropriate officer immediately 
of such change. 
‘‘(5) INDIVIDUAL PLANT OR PREMISES.—An ap-
plication for a basic permit must be filed, and per-
mit issued, to cover each individual plant or prem-
ises where any of the businesses specified in this sec-
tion is engaged in. 
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‘‘(6) DEADLINE.—Within 90 days of receipt of 
an application, the Secretary or their designee must 
notify the applicant whether the application has been 
approved or denied. This 90-day period may be ex-
tended once, by an additional 90 days, if the Sec-
retary or their designee finds that unusual cir-
cumstances require additional time to consider the 
issues presented by an application. If the Secretary 
or the appropriate designee extends the period, he or 
she must notify the applicant by letter, along with 
a brief explanation of the unusual circumstances 
causing the time period for consideration of the ap-
plication to be extended. If the applicant receives no 
decision from the Secretary or their designee within 
the time periods set forth in this paragraph, the ap-
plicant may file a mandamus action as provided for 
in this section. 
‘‘SEC. 303. DEFINITIONS. 
‘‘In this title— 
‘‘(1) the term ‘marijuana’ or ‘cannabis’ has the 
same meaning given the term ‘marihuana’ in section 
102 of the Controlled Substances Act (21 U.S.C. 
121); and 
‘‘(2) the term ‘State’ includes the District of 
Columbia, Puerto Rico, and any commonwealth, ter-
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ritory, enclave, Indian Tribe, or possession of the 
United States.’’. 
TITLE III—DESIGNATED STATE 
MEDICAL 
CANNABIS 
PROD-
UCT SAFETY ACT 
SEC. 301. GRANDFATHERING OF STATE MEDICAL CANNABIS 
PRODUCTS INTO INTERSTATE COMMERCE. 
Subchapter V of chapter 9 of title 21 of the United 
States Code (the Federal Food, Drug, and Cosmetic Act) 
is amended by adding at the end the following new part: 
‘‘PART J—DESIGNATED STATE MEDICAL 
CANNABIS PRODUCTS 
‘‘Sec. 360ggg. Definitions. 
‘‘Sec. 360ggg–1. Regulation of medical cannabis products. 
‘‘Sec. 360ggg–2. Cannabis-infused foods, beverages, and supplements. 
‘‘Sec. 360ggg–3. Cannabis cosmetics. 
‘‘Sec. 360ggg–4. Liability and method of payment. 
‘‘Sec. 360ggg–5. Private right of action and administrative remedy. 
‘‘SEC. 360ggg. DEFINITIONS. 
‘‘In this part: 
‘‘(1) The term ‘designated State medical can-
nabis product’— 
‘‘(A) means an article that is produced by 
a State and federally licensed or permitted med-
ical cannabis business, pursuant to a State 
medical cannabis program and contains ‘mari-
huana’, as defined in section 102(16) of the 
Controlled Substances Act; 
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‘‘(B) means any other article that contains 
either ‘marihuana’, as defined in section 102 of 
the Controlled Substances Act, deemed appro-
priate by the Secretary, after taking into ac-
count any investigational new drug application 
or investigational new animal drug application 
for the same medical cannabis product sub-
mitted in accordance with regulations applicable 
to such applications in title 21 of the Code of 
Federal Regulations, unless any period of exclu-
sivity 
for 
a 
new 
drug 
under 
section 
355(c)(3)(E)(ii) 
of 
this 
title 
or 
section 
355(j)(5)(F)(ii) of this title, or the extension of 
any such period under section 355a of this title, 
or any period of exclusivity for a new animal 
drug under section 360b(c)(2)(F) of this title, 
applicable to such medical cannabis product has 
not expired; 
‘‘(C) means any article that contains either 
‘marihuana’, as defined in section 102(16) of 
the Controlled Substances Act, that also meets 
the standards set forth in an official compen-
dium; and 
‘‘(D) does not mean articles or cannabis 
products produced and intended for nonmedical 
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