Prescription Drug Amendments of 1992
PL 102-353 (S.3163), enacted 08/26/1992

PUBLIC LAW 102-353—AUG. 26, 1992 
106 STAT. 941 
Public Law 102-353 
102d Congress 
An Act 
To amend the Federal Food, Drug, and Cosmetic Act to coordinate Federal and 
Aug. 26, 1992 
State regulation of wholesale drug distribution, and for other purposes. 
[S. 3163] 
Be it enacted by the Senate and House of Representatives of 
the United States of 
America in Congress assembled, 
Prescription 
SECTION 1. SHORT TITLE AND REFERENCE. 
A
.
'
V
^
S
o
™
®
"
*
® 
of 1992. 
(a) SHORT TITLE.—This Act may be cited as the "Prescription 21 use 30i note. 
Drug Amendments of 1992". 
(b) REFERENCE.—^Whenever in this Act an amendment or repeal 
is expressed in terms of an amendment to, or repeal of, a section 
or otiier provision, the reference shall be considered to be made 
to a section or other provision of the Federal Food, Drug, and 
Cosmetic Act. 
SEC. 2. DISTRIBUTOR REGISTRATION. 
(a) REQUIREMENT.—Section 503(e)(2)(A) (21 U.S.C. 353(e)(2)(A)) 
is amended by inserting before the period the following: "or has 
registered with the Secretary in accordance with paragraph (3)". 
(b) REGISTRATION.—Section 503(e) (21 U.S.C. 353(e)) is amended 
by redesignating paragraph (3) as paragraph (4) and by inserting 
after paragraph (2) the following: 
"(3) Any person who engages in the wholesale distribution in 
interstate commerce of drugs that are subject to subsection (b) 
in a State that does not have a program that meets the guidelines 
established under paragraph (2)(B) shall register with the Secretary 
the following: 
"(A) llie person's name and place of business. 
"(B) The name of each establishment the person owns or 
operates that is engaged in the wholesale distribution of drugs 
in a State that does not have a program to license persons 
engaged in such distribution.". 
(c) TECHNICAL.—Section 503(f)(1)(B) (21 U.S.C. 353(f)(1)(B)) is 
amended by striking out "and order" and inserting in lieu thereof 
"an order". 
(d) SUNSET.—Effective September 14, 1994, the amendments 
made by subsections (a) and (b) shall no longer be in effect. 
SEC 3. PENALTY CLARIFICATION. 
(a) SCIENTER.—Paragraph (1) of section 303(b) (21 U.S.C. 333(b)) 21 use 353 note, 
is amended to read as follows: 
"(b)(1) Notwithstanding subsection (a), any person who violates 
section 301(t) by— 
"(A) knowingly importing a drug in violation of section 
801(d)(1), 
"(B) knowingly selling, purchasing, or trading a drug or drug 
sample or knowingly offering to sell, purchase, or trade a drug 
or drug sample, in violation of section 503(c)(1), 
106 STAT. 942 
PUBLIC LAW 102-353—AUG. 26, 1992 
''(C) knowingly selling, purchasing, or trading a coupon, 
knowingly offering to sell, purchase, or trade such a coupon, 
or knowingly counterfeiting such a coupon, in violation of sec-
tion 503(c)(2), or 
"(D) knowingly distributing drugs in violation of section 
503(eX2XA), 
shall be imprisoned for not more than 10 years or fined not more 
than $250,000, or both.", 
(b) CLARIFICATION.—Section 303 (21 U.S.C. 333) is amended— 
(1) in subparagraphs (A) and (B)(i) of subsection (b)(4), by 
striking out **the arrest and conviction of each time it occurs 
and inserting in lieu thereof "the institution of a criminal 
proceeding against, and conviction of,"; 
(2) in subparagraph (B)(i) of subsection (b)(4), by striking 
out "the arrest of and inserting in lieu thereof "the institution 
of a criminal proceeding against"; 
(3) in subsection (b)(5), by striking out "the arrest and convic-
tion of and inserting in Ueu thereof "the institution of a crimi-
nal proceeding against, and conviction of,"; 
(4) in subsections (c) and (d), by striking out "subsection 
(a) of this section" and inserting in lieu thereof "subsection 
(a)(1) of this section"; and 
(5) in subsection (d), by striking out ", and no person" and 
all that follows through "mislead". 
SEC. 4. DRUG SAMPLES. 
Section 503 (21 U.S.C. 353) is amended— 
(1) in subsection (d), by sunending paragraph (1) to read 
as follows: 
"(d)(1) Except as provided in psuragraphs (2) and (3), no person 
may distribute any drug sample. For purposes of this subsection, 
the term 'distribute* does not include the providing of a drug sample 
to a patient by a— 
"(A) practitioner licensed to prescribe such drug, 
"(B) health care professional acting at the direction and under 
the supervision of such a practitioner, or 
"(C) pharmacy of a hospital or of another health care entity 
that is acting at the direction of such a practitioner and that 
received such sample pursuant to paragraph (2) or (3).". 
(2) in paragraphs (2) and (3) of subsection (d), by striking 
out "distributor" each place it occxirs and inserting in lieu 
thereof "authorized distributor of record" and in subsection 
(d)(3) by striking out "distributors" each place it occurs and 
inserting in Ueu thereof "authorized distributors of record"; 
(3) in subsection (e), by amending paragraph (1) to read 
as follows: 
"(e)(1)(A) Each person who is engaged in the wholesale dis-
tribution of a drug subject to subsection (b) and who is not the 
manufacturer or an aumorized distributor of record of such drug 
shall, before each wholessde distribution of such drug (including 
each distribution to an authorized distributor of record or to a 
retail pharmacy), provide to the person who receives the drug 
a statement (in such form and containing such information as 
the Secretary may require) identifying each prior sale, purchase, 
or trade of such drug (including the date of the transaction and 
the names and addresses of all p^*ties to the transaction). 
PUBLIC LAW 102-353—AUG. 26, 1992 
106 STAT. 943 
**(B) Each mamifacturer of a drug subject to subsection (b) shall 
maintain at its corporate offices a ciirrent list of the authorized 
distributors of record of such drug."; and 
(4) in subsection (e)(4) (as so redesignated by section 2(c)), 
by inserting before the dash the following: "and subsection 
(d)". 
SEC. 6. TECHNICAL AMENDMENT. 
Section 801(dXl) (21 U.S.C. 381(d)(1)) is amended by striking 
out "person who manufactured" and inserting in Heu thereof "manu-
facturer of. 
Approved August 26, 1992. 
LEGISLATIVE HISTORY—S. 3163: 
CONGRESSIONAL RECORD, Vol. 138 (1992): 
Aug. 11, considered and passed Senate. 
Aug. 12, considered and passed House.