
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC360cc]

 
                        TITLE 21--FOOD AND DRUGS
 
             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
 
                     SUBCHAPTER V--DRUGS AND DEVICES
 
              Part B--Drugs for Rare Diseases or Conditions
 
Sec. 360cc. Protection for drugs for rare diseases or conditions


(a) Exclusive approval, certification, or license

    Except as provided in subsection (b) of this section, if the 
Secretary--
        (1) approves an application filed pursuant to section 355 of 
    this title, or
        (2) issues a license under section 262 of title 42

for a drug designated under section 360bb of this title for a rare 
disease or condition, the Secretary may not approve another application 
under section 355 of this title or issue another license under section 
262 of title 42 for such drug for such disease or condition for a person 
who is not the holder of such approved application, of such 
certification, or of such license until the expiration of seven years 
from the date of the approval of the approved application, the issuance 
of the certification, or the issuance of the license. Section 355(c)(2) 
of this title does not apply to the refusal to approve an application 
under the preceding sentence.

(b) Exceptions

    If an application filed pursuant to section 355 of this title is 
approved for a drug designated under section 360bb of this title for a 
rare disease or condition or if a license is issued under section 262 of 
title 42 for such a drug, the Secretary may, during the seven-year 
period beginning on the date of the application approval or of the 
issuance of the license, approve another application under section 355 
of this title or issue a license under section 262 of title 42, for such 
drug for such disease or condition for a person who is not the holder of 
such approved application or of such license if--
        (1) the Secretary finds, after providing the holder notice and 
    opportunity for the submission of views, that in such period the 
    holder of the approved application or of the license cannot assure 
    the availability of sufficient quantities of the drug to meet the 
    needs of persons with the disease or condition for which the drug 
    was designated; or
        (2) such holder provides the Secretary in writing the consent of 
    such holder for the approval of other applications or the issuance 
    of other licenses before the expiration of such seven-year period.

(June 25, 1938, ch. 675, Sec. 527, as added Pub. L. 97-414, Sec. 2(a), 
Jan. 4, 1983, 96 Stat. 2050; amended Pub. L. 98-417, title I, 
Sec. 102(b)(6), Sept. 24, 1984, 98 Stat. 1593; Pub. L. 99-91, Secs. 2, 
3(a)(3), Aug. 15, 1985, 99 Stat. 387, 388; Pub. L. 103-80, Sec. 3(v), 
Aug. 13, 1993, 107 Stat. 778; Pub. L. 105-115, title I, 
Sec. 125(b)(2)(J), (K), Nov. 21, 1997, 111 Stat. 2326.)


                               Amendments

    1997--Subsec. (a). Pub. L. 105-115, Sec. 125(b)(2)(J), struck out 
``, issue another certification under section 357 of this title,'' 
before ``or issue another license'' in closing provisions, inserted 
``or'' at end of par. (1), redesignated par. (3) as (2), and struck out 
former par. (2) which read as follows: ``issues a certification under 
section 357 of this title, or''.
    Subsec. (b). Pub. L. 105-115, Sec. 125(b)(2)(K), in introductory 
provisions, struck out ``, if a certification is issued under section 
357 of this title for such a drug,'' after ``rare disease or 
condition'', ``, of the issuance of the certification under section 357 
of this title,'' after ``application approval'', ``, issue another 
certification under section 357 of this title,'' after ``application 
under section 355 of this title'', and ``, of such certification,'' 
after ``approved application''.
    Subsec. (b)(1). Pub. L. 105-115, Sec. 125(b)(2)(K), struck out ``, 
of the certification,'' after ``holder of the approved application''.
    Subsec. (b)(2). Pub. L. 105-115, Sec. 125(b)(2)(K), struck out ``, 
issuance of other certifications,'' after ``approval of other 
applications''.
    1993--Subsec. (b). Pub. L. 103-80 struck out extraneous comma before 
``or issue a license under section 262'' in introductory provisions and 
substituted ``the'' for ``The'' at beginning of par. (1).
    1985--Pub. L. 99-91, Sec. 2(3), struck out ``unpatented'' before 
``drugs'' in section catchline.
    Subsec. (a). Pub. L. 99-91, Secs. 2(1), 3(a)(3)(A)-(D), struck out 
``or'' at end of par. (1), added par. (2), redesignated former par. (2) 
as (3), struck out ``and for which a United States Letter of Patent may 
not be issued'' after ``rare disease or condition'', inserted in first 
sentence ``, issue another certification under section 357 of this 
title,'' after ``section 355 of this title'' the second time it 
appeared, inserted ``, of such certification,'' after ``holder of such 
approved application'', and inserted ``, the issuance of the 
certification,'' after ``approval of the approved application''.
    Subsec. (b). Pub. L. 99-91, Secs. 2(2), 3(a)(3)(E)-(K), struck out 
``and if a United States Letter of Patent may not be issued for the 
drug'' after ``such a drug'', substituted ``, if a certification is 
issued under section 357 of this title for such a drug, or if a 
license'' for ``or a license'', inserted ``, of the issuance of the 
certification under section 357 of this title,'' after ``application 
approval'', struck out ``, if the drug is a biological product,'' before 
``issue a license'', inserted ``, issue another certification under 
section 357 of this title,'' after ``section 355 of this title'', 
inserted ``, of such certification,'' after ``holder of such approved 
application'', inserted ``, of such certification,'' after 
``application'' in par. (1), and inserted ``, issuance of other 
certifications,'' after ``other applications'' in par. (2).
    1984--Subsecs. (a), (b). Pub. L. 98-417 substituted ``section 355'' 
for ``section 355(b)'' wherever appearing.


                    Effective Date of 1985 Amendment

    Amendment by Pub. L. 99-91 effective Aug. 15, 1985, see section 8(b) 
of Pub. L. 99-91, set out as a note under section 360aa of this title.

                  Section Referred to in Other Sections

    This section is referred to in section 355a of this title.
