in accordance with title 18, United States Code, or impris-
oned for any term of years or for life, or both.’’. 
(b) NOTIFICATION OF FOOD AND DRUG ADMINIS-
TRATION BY MANUFACTURERS.—Section 505(k) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(k)) 
is amended by adding at the end the following paragraph: 
‘‘(3) A manufacturer of a drug that receives or other-
wise becomes aware of information that reasonably sug-
gests that a violation described in paragraph (3) or (4) 
of section 303(a) may have occurred with respect to the 
drug shall report such information to the Secretary not 
later than 48 hours after first receiving or otherwise be-
coming aware of the information.’’. 
SEC. 3. USE OF TECHNOLOGIES FOR PREVENTING COUN-
TERFEITING OF DRUGS. 
Section 502 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 352) is amended by adding at the end the 
following: 
‘‘(aa) If it is a drug and it is not manufactured in 
accordance with any regulations of the Secretary requiring 
the use of technologies that the Secretary has determined 
are technically feasible and will assist in preventing viola-
tions of this Act to which paragraphs (3) and (4) of sec-
tion 303(a) apply (relating to the knowing adulteration or 
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misbranding of drugs and the knowing misrepresentation 
of drugs).’’. 
SEC. 4. WHOLESALE DISTRIBUTION OF DRUGS; STATE-
MENTS REGARDING PRIOR SALE, PURCHASE, 
OR TRADE. 
(a) STRIKING
OF EXEMPTIONS
FOR AUTHORIZED 
DISTRIBUTORS OF RECORD.—Section 503(e) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 353(e)) 
is amended— 
(1) in paragraph (1)— 
(A) by striking ‘‘and who is not the manu-
facturer or an authorized distributor of record 
of such drug’’; 
(B) by striking ‘‘to an authorized dis-
tributor of record or’’; and 
(C) by striking subparagraph (B) and in-
serting the following: 
‘‘(B) The Secretary shall by regulation establish re-
quirements (referred to in this subparagraph as ‘alter-
native requirements’) that supersede subparagraph (A) to 
identify the chain of custody of a drug subject to sub-
section (b) from the manufacturer of the drug throughout 
the wholesale distribution of the drug to a pharmacist who 
intends to sell the drug at retail if the Secretary deter-
mines that— 
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‘‘(i) the alternative requirements (which may in-
clude standardized anticounterfeiting or track-and- 
trace technologies) will identify such chain of cus-
tody, or the identity of the discrete package of the 
drug from which the drug is dispensed, with equal 
or greater certainty than the requirements of sub-
paragraph (A); and 
‘‘(ii) the alternative requirements are tech-
nically feasible.’’; and 
(2) in paragraph (3), by striking ‘‘and sub-
section (d)—’’ in the matter preceding subparagraph 
(A) and all that follows through ‘‘the term ‘whole-
sale distribution’ means’’ in subparagraph (B) and 
inserting the following: ‘‘and subsection (d), the 
term ‘wholesale distribution’ means’’. 
(b) CONFORMING AMENDMENT.—Section 503(d) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
353(d)) is amended by adding at the end the following: 
‘‘(4) Each manufacturer of a drug subject to sub-
section (b) shall maintain at its corporate offices a current 
list of the authorized distributors of record of such drug. 
‘‘(5) For purposes of this subsection, the term ‘au-
thorized distributors of record’ means any distributor that 
a manufacturer designates as an authorized distributor of 
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record and whose name the manufacturer makes publicly 
available.’’. 
(c) FINAL RULE.—The Secretary shall ensure that, 
not later than 90 days after the date of the enactment 
of this Act, there is in effect a final rule to implement 
section 503(e) of the Federal Food, Drug, and Cosmetic 
Act, including the amendments made by this section. 
SEC. 5. COUNTERFEIT DRUGS; INCREASED FUNDING FOR 
INSPECTIONS, EXAMINATIONS, AND INVES-
TIGATIONS. 
For the purpose of increasing the capacity of the 
Food and Drug Administration to conduct inspections, ex-
aminations, and investigations under the Federal Food, 
Drug, and Cosmetic Act with respect to violations de-
scribed in paragraphs (3) and (4) of section 303(a) of such 
Act, there is authorized to be appropriated $60,000,000 
for each of the fiscal years 2010 through 2014, in addition 
to other authorizations of appropriations that are available 
for such purpose. 
SEC. 6. PUBLIC EDUCATION REGARDING COUNTERFEIT 
DRUGS. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services shall carry out a program to educate the 
public and health care professionals on counterfeit drugs, 
including techniques to identify drugs as counterfeit. 
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(b) AUTHORIZATION OF APPROPRIATIONS.—For the 
purpose of carrying out subsection (a), there is authorized 
to be appropriated $5,000,000 for each of the fiscal years 
2010 through 2014, in addition to other authorizations 
of appropriations that are available for such purpose. 
SEC. 7. RECALL AUTHORITY REGARDING DRUGS. 
Subchapter A of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed by inserting after section 506C the following section: 
‘‘SEC. 506D. RECALL AUTHORITY. 
‘‘(a) ORDER TO CEASE DISTRIBUTION OF DRUG; 
NOTIFICATION OF HEALTH PROFESSIONALS.— 
‘‘(1) IN GENERAL.—If the Secretary finds that 
there is a reasonable probability that a drug in-
tended for human use would cause serious, adverse 
health consequences or death, the Secretary shall 
issue an order requiring the appropriate person (in-
cluding the manufacturers, importers, distributors, 
or retailers of the drug)— 
‘‘(A) to immediately cease distribution of 
the drug; and 
‘‘(B) to immediately notify health profes-
sionals of the order and to instruct such profes-
sionals to cease administering or prescribing the 
drug. 
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