256 
‘‘(i) patients with serious or life- 
threatening diseases or conditions; and 
‘‘(ii) patients who have difficulty ac-
cessing health care (such as patients in 
rural or medically underserved areas); and 
‘‘(D) to the extent practicable, so as to 
minimize the burden on the health care delivery 
system— 
‘‘(i) conform with elements to assure 
safe use for other drugs with similar, seri-
ous risks; and 
‘‘(ii) be designed to be compatible 
with established distribution, procurement, 
and dispensing systems for drugs. 
‘‘(3) ELEMENTS.—The restrictions on distribu-
tion or use described in paragraph (1) shall include 
1 or more goals to evaluate or mitigate a serious 
risk listed in the labeling of the drug, and may re-
quire that— 
‘‘(A) health care providers that prescribe 
the drug have special training or experience, or 
are specially certified, which training or certifi-
cation with respect to the drug is available to 
any willing provider from a frontier area; 
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‘‘(B) pharmacies, practitioners, or health 
care settings that dispense the drug are spe-
cially certified, which training or certification 
with respect to the drug is available to any will-
ing provider from a frontier area; 
‘‘(C) the drug be dispensed to patients only 
in certain health care settings, such as hos-
pitals; 
‘‘(D) the drug be dispensed to patients 
with evidence or other documentation of safe- 
use conditions, such as laboratory test results; 
‘‘(E) each patient using the drug be sub-
ject to certain monitoring; or 
‘‘(F) each patient using the drug be en-
rolled in a registry. 
‘‘(4) IMPLEMENTATION SYSTEM.—The restric-
tions on distribution or use described in paragraph 
(1) may require a system through which the respon-
sible person is able to— 
‘‘(A) monitor and evaluate implementation 
of the restrictions by health care providers, 
pharmacists, patients, and other parties in the 
health care system who are responsible for im-
plementing the restrictions; 
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258 
‘‘(B) work to improve implementation of 
the restrictions by health care providers, phar-
macists, patients, and other parties in the 
health care system who are responsible for im-
plementing the restrictions; and 
‘‘(C) notify wholesalers of the drug of 
those health care providers— 
‘‘(i) who are responsible for imple-
menting the restrictions; and 
‘‘(ii) whom the responsible person 
knows have failed to meet their responsibil-
ities for implementing the restrictions, 
after the responsible person has informed 
such party of such failure and such party 
has not remedied such failure. 
‘‘(5) LIMITATION.—No holder of an approved 
application shall use any restriction on distribution 
required by the Secretary as necessary to assure safe 
use of the drug to block or delay approval of an ap-
plication under section 505(b)(2) or (j) or to prevent 
application of such restriction under subsection 
(i)(1)(B) to a drug that is the subject of an abbre-
viated new drug application. 
‘‘(6) 
BIOEQUIVALENCE
TESTING.—Notwith-
standing any other provisions in this subsection, the 
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259 
holder of an approved application that is subject to 
distribution restrictions required under this sub-
section that limit the ability of a sponsor seeking ap-
proval of an application under subsection 505(b)(2) 
or (j) to purchase on the open market a sufficient 
quantity of drug to conduct bioequivalence testing 
shall provide to such a sponsor a sufficient amount 
of drug to conduct bioequivalence testing if the spon-
sor seeking approval under section 505(b)(2) or 
(j)— 
‘‘(A) agrees to such restrictions on dis-
tribution as the Secretary finds necessary to as-
sure safe use of the drug during bioequivalence 
testing; and 
‘‘(B) pays the holder of the approved appli-
cation the fair market value of the drug pur-
chased for bioequivalence testing. 
‘‘(7) LETTER BY SECRETARY.—Upon a showing 
by the sponsor seeking approval under section 
505(b)(2) or (j) that the sponsor has agreed to such 
restrictions necessary to assure safe use of the drug 
during bioequivalence testing, the Secretary shall 
issue to the sponsor seeking to conduct bioequiva-
lence testing a letter that describes the Secretary’s 
finding which shall serve as proof that the sponsor 
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