vidual patient, which produces for that patient a sig-
nificant difference, as determined by the prescribing 
practitioner, between the compounded drug and the 
comparable commercially available drug product, 
provided that in the case of a radioactive drug (as 
defined in section 310.3(n) of title 21, Code of Fed-
eral Regulations (or any successor regulations)), the 
reasons for the determination by the prescribing 
practitioner have been documented and such docu-
mentation is maintained by the pharmacy. 
‘‘(3) The term ‘high-risk sterile compounding’ 
means compounding sterile drug products using non-
sterile ingredients, nonsterile devices, or nonsterile 
components.’’. 
(b) MISBRANDING.—Section 502 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amend-
ed by adding at the end the following: 
‘‘(bb) If it is a drug product compounded pursuant 
to section 503A and its labeling does not include the infor-
mation required by section 503A(i). 
‘‘(cc) If it is a drug, and it was manufactured, pre-
pared, propagated, compounded, or processed by a 
compounding manufacturer for which fees have not been 
paid as required by section 503A(k).’’. 
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(c) 
CONFORMING
AMENDMENT.—Section 
704(a)(2)(A) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 374(a)(2)(A)) is amended by inserting 
‘‘subject to section 503A,’’ before ‘‘pharmacies which 
maintain establishments’’. 
(d) REGULATIONS.—Not later than 1 year after the 
date of the enactment of this Act, the Secretary shall pro-
mulgate final regulations for carrying out the amendments 
made by subsections (a), (b), and (c). 
(e) EFFECTIVE DATE.—The amendments made by 
subsections (a), (b), and (c) shall take effect on the date 
that is 1 year after the date of the enactment of this Act. 
SEC. 3. REGISTRATION OF MANUFACTURERS COMPOUND-
ING DRUG PRODUCTS. 
(a) REGISTRATION.—Section 510(g) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360(g)) is 
amended by adding at the end the following: ‘‘With respect 
to compounding drugs, the exemption in paragraph (1) 
does not apply with respect to any pharmacy to the extent 
to which the pharmacy is, in effect, manufacturing such 
drugs, as determined by the Secretary, taking into consid-
eration the extent to which such pharmacy sells the drugs 
across State lines, the quantity of the drugs sold, and any 
other factors determined appropriate by the Secretary.’’. 
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(b) REGULATIONS.—Not later than 1 year after the 
date of the enactment of this Act, the Secretary of Health 
and Human Services shall promulgate regulations for car-
rying out the amendment made by subsection (a). 
(c) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall take effect on the date that is 1 year 
after the date of the enactment of this Act. 
SEC. 4. NO PREEMPTION OF ADDITIONAL NON-FEDERAL 
REQUIREMENTS. 
The requirements of this Act (including the require-
ments of the amendments made by this Act) do not pre-
empt any non-Federal requirement that is in addition to, 
and compatible with, such requirements. 
Æ 
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