US Laws, Codes, Statutes & Cases

From the U.S. Code Online via GPO Access
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[Laws in effect as of January 24, 2002]
[Document not affected by Public Laws enacted between
  January 24, 2002 and December 19, 2002]
[CITE: 21USC360]

 
                        TITLE 21--FOOD AND DRUGS
 
             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
 
                     SUBCHAPTER V--DRUGS AND DEVICES
 
                        Part A--Drugs and Devices
 
Sec. 360. Registration of producers of drugs or devices


(a) Definitions

    As used in this section--
        (1) the term ``manufacture, preparation, propagation, 
    compounding, or processing'' shall include repackaging or otherwise 
    changing the container, wrapper, or labeling of any drug package or 
    device package in furtherance of the distribution of the drug or 
    device from the original place of manufacture to the person who 
    makes final delivery or sale to the ultimate consumer or user; and
        (2) the term ``name'' shall include in the case of a partnership 
    the name of each partner and, in the case of a corporation, the name 
    of each corporate officer and director, and the State of 
    incorporation.

(b) Annual registration

    On or before December 31 of each year every person who owns or 
operates any establishment in any State engaged in the manufacture, 
preparation, propagation, compounding, or processing of a drug or drugs 
or a device or devices shall register with the Secretary his name, 
places of business, and all such establishments.

(c) New producers

    Every person upon first engaging in the manufacture, preparation, 
propagation, compounding, or processing of a drug or drugs or a device 
or devices in any establishment which he owns or operates in any State 
shall immediately register with the Secretary his name, place of 
business, and such establishment.

(d) Additional establishments

    Every person duly registered in accordance with the foregoing 
subsections of this section shall immediately register with the 
Secretary any additional establishment which he owns or operates in any 
State and in which he begins the manufacture, preparation, propagation, 
compounding, or processing of a drug or drugs or a device or devices.

(e) Registration number; uniform system for identification of devices 
        intended for human use

    The Secretary may assign a registration number to any person or any 
establishment registered in accordance with this section. The Secretary 
may also assign a listing number to each drug or class of drugs listed 
under subsection (j) of this section. Any number assigned pursuant to 
the preceding sentence shall be the same as that assigned pursuant to 
the National Drug Code. The Secretary may by regulation prescribe a 
uniform system for the identification of devices intended for human use 
and may require that persons who are required to list such devices 
pursuant to subsection (j) of this section shall list such devices in 
accordance with such system.

(f) Availability of registrations for inspection

    The Secretary shall make available for inspection, to any person so 
requesting, any registration filed pursuant to this section; except that 
any list submitted pursuant to paragraph (3) of subsection (j) of this 
section and the information accompanying any list or notice filed under 
paragraph (1) or (2) of that subsection shall be exempt from such 
inspection unless the Secretary finds that such an exemption would be 
inconsistent with protection of the public health.

(g) Exclusions from application of section

    The foregoing subsections of this section shall not apply to--
        (1) pharmacies which maintain establishments in conformance with 
    any applicable local laws regulating the practice of pharmacy and 
    medicine and which are regularly engaged in dispensing prescription 
    drugs or devices, upon prescriptions of practitioners licensed to 
    administer such drugs or devices to patients under the care of such 
    practitioners in the course of their professional practice, and 
    which do not manufacture, prepare, propagate, compound, or process 
    drugs or devices for sale other than in the regular course of their 
    business of dispensing or selling drugs or devices at retail;
        (2) practitioners licensed by law to prescribe or administer 
    drugs or devices and who manufacture, prepare, propagate, compound, 
    or process drugs or devices solely for use in the course of their 
    professional practice;
        (3) persons who manufacture, prepare, propagate, compound, or 
    process drugs or devices solely for use in research, teaching, or 
    chemical analysis and not for sale;
        (4) any distributor who acts as a wholesale distributor of 
    devices, and who does not manufacture, repackage, process, or 
    relabel a device; or
        (5) such other classes of persons as the Secretary may by 
    regulation exempt from the application of this section upon a 
    finding that registration by such classes of persons in accordance 
    with this section is not necessary for the protection of the public 
    health.

In this subsection, the term ``wholesale distributor'' means any person 
(other than the manufacturer or the initial importer) who distributes a 
device from the original place of manufacture to the person who makes 
the final delivery or sale of the device to the ultimate consumer or 
user.

(h) Inspection of premises

    Every establishment in any State registered with the Secretary 
pursuant to this section shall be subject to inspection pursuant to 
section 374 of this title and every such establishment engaged in the 
manufacture, propagation, compounding, or processing of a drug or drugs 
or of a device or devices classified in class II or III shall be so 
inspected by one or more officers or employees duly designated by the 
Secretary, or by persons accredited to conduct inspections under section 
374(g) of this title, at least once in the two-year period beginning 
with the date of registration of such establishment pursuant to this 
section and at least once in every successive two-year period 
thereafter.

(i) Registration of foreign establishments

    (1) On or before December 31 of each year, any establishment within 
any foreign country engaged in the manufacture, preparation, 
propagation, compounding, or processing of a drug or a device that is 
imported or offered for import into the United States shall, through 
electronic means in accordance with the criteria of the Secretary, 
register with the Secretary the name and place of business of the 
establishment, the name of the United States agent for the 
establishment, the name of each importer of such drug or device in the 
United States that is known to the establishment, and the name of each 
person who imports or offers for import such drug or device to the 
United States for purposes of importation.
    (2) The establishment shall also provide the information required by 
subsection (j) of this section.
    (3) The Secretary is authorized to enter into cooperative 
arrangements with officials of foreign countries to ensure that adequate 
and effective means are available for purposes of determining, from time 
to time, whether drugs or devices manufactured, prepared, propagated, 
compounded, or processed by an establishment described in paragraph (1), 
if imported or offered for import into the United States, shall be 
refused admission on any of the grounds set forth in section 381(a) of 
this title.

(j) Filing of lists of drugs and devices manufactured, prepared, 
        propagated and compounded by registrants; statements; 
        accompanying disclosures

    (1) Every person who registers with the Secretary under subsection 
(b), (c), (d), or (i) of this section shall, at the time of registration 
under any such subsection, file with the Secretary a list of all drugs 
and a list of all devices and a brief statement of the basis for 
believing that each device included in the list is a device rather than 
a drug (with each drug and device in each list listed by its established 
name (as defined in section 352(e) of this title) and by any proprietary 
name) which are being manufactured, prepared, propagated, compounded, or 
processed by him for commercial distribution and which he has not 
included in any list of drugs or devices filed by him with the Secretary 
under this paragraph or paragraph (2) before such time of registration. 
Such list shall be prepared in such form and manner as the Secretary may 
prescribe and shall be accompanied by--
        (A) in the case of a drug contained in the applicable list and 
    subject to section 355 or 360b of this title, or a device intended 
    for human use contained in the applicable list with respect to which 
    a performance standard has been established under section 360d of 
    this title or which is subject to section 360e of this title, a 
    reference to the authority for the marketing of such drug or device 
    and a copy of all labeling for such drug or device;
        (B) in the case of any other drug or device contained in an 
    applicable list--
            (i) which drug is subject to section 353(b)(1) of this 
        title, or which device is a restricted device, a copy of all 
        labeling for such drug or device, a representative sampling of 
        advertisements for such drug or device, and, upon request made 
        by the Secretary for good cause, a copy of all advertisements 
        for a particular drug product or device, or
            (ii) which drug is not subject to section 353(b)(1) of this 
        title or which device is not a restricted device, the label and 
        package insert for such drug or device and a representative 
        sampling of any other labeling for such drug or device;

        (C) in the case of any drug contained in an applicable list 
    which is described in subparagraph (B), a quantitative listing of 
    its active ingredient or ingredients, except that with respect to a 
    particular drug product the Secretary may require the submission of 
    a quantitative listing of all ingredients if he finds that such 
    submission is necessary to carry out the purposes of this chapter; 
    and
        (D) if the registrant filing a list has determined that a 
    particular drug product or device contained in such list is not 
    subject to section 355 or 360b of this title, or the particular 
    device contained in such list is not subject to a performance 
    standard established under section 360d of this title or to section 
    360e of this title or is not a restricted device a brief statement 
    of the basis upon which the registrant made such determination if 
    the Secretary requests such a statement with respect to that 
    particular drug product or device.

    (2) Each person who registers with the Secretary under this section 
shall report to the Secretary once during the month of June of each year 
and once during the month of December of each year the following 
information:
        (A) A list of each drug or device introduced by the registrant 
    for commercial distribution which has not been included in any list 
    previously filed by him with the Secretary under this subparagraph 
    or paragraph (1) of this subsection. A list under this subparagraph 
    shall list a drug or device by its established name (as defined in 
    section 352(e) of this title), and by any proprietary name it may 
    have and shall be accompanied by the other information required by 
    paragraph (1).
        (B) If since the date the registrant last made a report under 
    this paragraph (or if he has not made a report under this paragraph, 
    since February 1, 1973) he has discontinued the manufacture, 
    preparation, propagation, compounding, or processing for commercial 
    distribution of a drug or device included in a list filed by him 
    under subparagraph (A) or paragraph (1); notice of such 
    discontinuance, the date of such discontinuance, and the identity 
    (by established name (as defined in section 352(e) of this title) 
    and by any proprietary name) of such drug or device.
        (C) If since the date the registrant reported pursuant to 
    subparagraph (B) a notice of discontinuance he has resumed the 
    manufacture, preparation, propagation, compounding, or processing 
    for commercial distribution of the drug or device with respect to 
    which such notice of discontinuance was reported; notice of such 
    resumption, the date of such resumption, the identity of such drug 
    or device (each by established name (as defined in section 352(e) of 
    this title) and by any proprietary name), and the other information 
    required by paragraph (1), unless the registrant has previously 
    reported such resumption to the Secretary pursuant to this 
    subparagraph.
        (D) Any material change in any information previously submitted 
    pursuant to this paragraph or paragraph (1).

    (3) The Secretary may also require each registrant under this 
section to submit a list of each drug product which (A) the registrant 
is manufacturing, preparing, propagating, compounding, or processing for 
commercial distribution, and (B) contains a particular ingredient. The 
Secretary may not require the submission of such a list unless he has 
made a finding that the submission of such a list is necessary to carry 
out the purposes of this chapter.

(k) Report preceding introduction of devices into interstate commerce

    Each person who is required to register under this section and who 
proposes to begin the introduction or delivery for introduction into 
interstate commerce for commercial distribution of a device intended for 
human use shall, at least ninety days before making such introduction or 
delivery, report to the Secretary or person who is accredited under 
section 360m(a) of this title (in such form and manner as the Secretary 
shall by regulation prescribe)--
        (1) the class in which the device is classified under section 
    360c of this title or if such person determines that the device is 
    not classified under such section, a statement of that determination 
    and the basis for such person's determination that the device is or 
    is not so classified, and
        (2) action taken by such person to comply with requirements 
    under section 360d or 360e of this title which are applicable to the 
    device.

(l) Exemption from reporting requirements

    A report under subsection (k) of this section is not required for a 
device intended for human use that is exempted from the requirements of 
this subsection under subsection (m) of this section or is within a type 
that has been classified into class I under section 360c of this title. 
The exception established in the preceding sentence does not apply to 
any class I device that is intended for a use which is of substantial 
importance in preventing impairment of human health, or to any class I 
device that presents a potential unreasonable risk of illness or injury.

(m) List of exempt class II devices; determination by Secretary; 
        publication in Federal Register

    (1) Not later than 60 days after November 21, 1997, the Secretary 
shall publish in the Federal Register a list of each type of class II 
device that does not require a report under subsection (k) of this 
section to provide reasonable assurance of safety and effectiveness. 
Each type of class II device identified by the Secretary as not 
requiring the report shall be exempt from the requirement to provide a 
report under subsection (k) of this section as of the date of the 
publication of the list in the Federal Register. The Secretary shall 
publish such list on the Internet site of the Food and Drug 
Administration. The list so published shall be updated not later than 30 
days after each revision of the list by the Secretary.
    (2) Beginning on the date that is 1 day after the date of the 
publication of a list under this subsection, the Secretary may exempt a 
class II device from the requirement to submit a report under subsection 
(k) of this section, upon the Secretary's own initiative or a petition 
of an interested person, if the Secretary determines that such report is 
not necessary to assure the safety and effectiveness of the device. The 
Secretary shall publish in the Federal Register notice of the intent of 
the Secretary to exempt the device, or of the petition, and provide a 
30-day period for public comment. Within 120 days after the issuance of 
the notice in the Federal Register, the Secretary shall publish an order 
in the Federal Register that sets forth the final determination of the 
Secretary regarding the exemption of the device that was the subject of 
the notice. If the Secretary fails to respond to a petition within 180 
days of receiving it, the petition shall be deemed to be granted.

(n) Review of report; time for determination by Secretary

    The Secretary shall review the report required in subsection (k) of 
this section and make a determination under section 360c(f)(1) of this 
title not later than 90 days after receiving the report.

(o) Reprocessed single-use devices

    (1) With respect to reprocessed single-use devices for which reports 
are required under subsection (k) of this section:
        (A) The Secretary shall identify such devices or types of 
    devices for which reports under such subsection must, in order to 
    ensure that the device is substantially equivalent to a predicate 
    device, include validation data, the types of which shall be 
    specified by the Secretary, regarding cleaning and sterilization, 
    and functional performance demonstrating that the single-use device 
    will remain substantially equivalent to its predicate device after 
    the maximum number of times the device is reprocessed as intended by 
    the person submitting the premarket notification. Within six months 
    after October 26, 2002, the Secretary shall publish in the Federal 
    Register a list of the types so identified, and shall revise the 
    list as appropriate. Reports under subsection (k) of this section 
    for devices or types of devices within a type included on the list 
    are, upon publication of the list, required to include such 
    validation data.
        (B) In the case of each report under subsection (k) of this 
    section that was submitted to the Secretary before the publication 
    of the initial list under subparagraph (A), or any revision thereof, 
    and was for a device or type of device included on such list, the 
    person who submitted the report under subsection (k) of this section 
    shall submit validation data as described in subparagraph (A) to the 
    Secretary not later than nine months after the publication of the 
    list. During such nine-month period, the Secretary may not take any 
    action under this chapter against such device solely on the basis 
    that the validation data for the device have not been submitted to 
    the Secretary. After the submission of the validation data to the 
    Secretary, the Secretary may not determine that the device is 
    misbranded under section 352(o) of this title, adulterated under 
    section 351(f)(1)(B) of this title, or take action against the 
    device under section 331(p) of this title for failure to provide any 
    information required by subsection (k) of this section until (i) the 
    review is terminated by withdrawal of the submission of the report 
    under subsection (k) of this section; (ii) the Secretary finds the 
    data to be acceptable and issues a letter; or (iii) the Secretary 
    determines that the device is not substantially equivalent to a 
    predicate device. Upon a determination that a device is not 
    substantially equivalent to a predicate device, or if such 
    submission is withdrawn, the device can no longer be legally 
    marketed.
        (C) In the case of a report under subsection (k) of this section 
    for a device identified under subparagraph (A) that is of a type for 
    which the Secretary has not previously received a report under such 
    subsection, the Secretary may, in advance of revising the list under 
    subparagraph (A) to include such type, require that the report 
    include the validation data specified in subparagraph (A).
        (D) Section 352(o) of this title applies with respect to the 
    failure of a report under subsection (k) of this section to include 
    validation data required under subparagraph (A).

    (2) With respect to critical or semi-critical reprocessed single-use 
devices that, under subsection (l) or (m) of this section, are exempt 
from the requirement of submitting reports under subsection (k) of this 
section:
        (A) The Secretary shall identify such devices or types of 
    devices for which such exemptions should be terminated in order to 
    provide a reasonable assurance of the safety and effectiveness of 
    the devices. The Secretary shall publish in the Federal Register a 
    list of the devices or types of devices so identified, and shall 
    revise the list as appropriate. The exemption for each device or 
    type included on the list is terminated upon the publication of the 
    list. For each report under subsection (k) of this section submitted 
    pursuant to this subparagraph the Secretary shall require the 
    validation data described in paragraph (1)(A).
        (B) For each device or type of device included on the list under 
    subparagraph (A), a report under subsection (k) of this section 
    shall be submitted to the Secretary not later than 15 months after 
    the publication of the initial list, or a revision of the list, 
    whichever terminates the exemption for the device. During such 15-
    month period, the Secretary may not take any action under this 
    chapter against such device solely on the basis that such report has 
    not been submitted to the Secretary. After the submission of the 
    report to the Secretary the Secretary may not determine that the 
    device is misbranded under section 352(o) of this title, adulterated 
    under section 351(f)(1)(B) of this title, or take action against the 
    device under section 331(p) of this title for failure to provide any 
    information required by subsection (k) of this section until (i) the 
    review is terminated by withdrawal of the submission; (ii) the 
    Secretary determines by order that the device is substantially 
    equivalent to a predicate device; or (iii) the Secretary determines 
    by order that the device is not substantially equivalent to a 
    predicate device. Upon a determination that a device is not 
    substantially equivalent to a predicate device, the device can no 
    longer be legally marketed.
        (C) In the case of semi-critical devices, the initial list under 
    subparagraph (A) shall be published not later than 18 months after 
    the effective date of this subsection. In the case of critical 
    devices, the initial list under such subparagraph shall be published 
    not later than six months after such effective date.
        (D) Section 352(o) of this title applies with respect to the 
    failure to submit a report under subsection (k) of this section that 
    is required pursuant to subparagraph (A), including a failure of the 
    report to include validation data required in such subparagraph.
        (E) The termination under subparagraph (A) of an exemption under 
    subsection (l) or (m) of this section for a critical or semicritical 
    reprocessed single-use device does not terminate the exemption under 
    subsection (l) or (m) of this section for the original device.

(p) Electronic registration

    Registrations under subsections (b), (c), (d), and (i) of this 
section (including the submission of updated information) shall be 
submitted to the Secretary by electronic means, upon a finding by the 
Secretary that the electronic receipt of such registrations is feasible, 
unless the Secretary grants a request for waiver of such requirement 
because use of electronic means is not reasonable for the person 
requesting such waiver.

(June 25, 1938, ch. 675, Sec. 510, as added Pub. L. 87-781, title III, 
Sec. 302, Oct. 10, 1962, 76 Stat. 794; amended Pub. L. 89-74, Sec. 4, 
July 15, 1965, 79 Stat. 231; Pub. L. 91-513, title II, Sec. 701(e), Oct. 
27, 1970, 84 Stat. 1282; Pub. L. 92-387, Secs. 3, 4(a)-(c), Aug. 16, 
1972, 86 Stat. 560-562; Pub. L. 94-295, Sec. 4(a), May 28, 1976, 90 
Stat. 579; Pub. L. 105-115, title I, Sec. 125(a)(2)(C), title II, 
Secs. 206(a), 209(a), 213(b), title IV, Sec. 417, Nov. 21, 1997, 111 
Stat. 2325, 2338, 2341, 2347, 2379; Pub. L. 107-188, title III, 
Sec. 321(a), June 12, 2002, 116 Stat. 675; Pub. L. 107-250, title II, 
Secs. 201(e), 207, 211, title III, Sec. 302(b), Oct. 26, 2002, 116 Stat. 
1609, 1613, 1614, 1616.)

                       References in Text

    The effective date of this subsection, referred to in subsec. 
(o)(2)(C), probably means the date of the enactment of Pub. L. 107-250, 
which enacted subsec. (o) of this section and was approved Oct. 26, 
2002.


                               Amendments

    2002--Subsec. (h). Pub. L. 107-250, Sec. 201(e), inserted ``, or by 
persons accredited to conduct inspections under section 374(g) of this 
title,'' after ``duly designated by the Secretary''.
    Subsec. (i)(1). Pub. L. 107-188, Sec. 321(a)(1), substituted ``On or 
before December 31 of each year, any establishment'' for ``Any 
establishment'' and ``shall, through electronic means in accordance with 
the criteria of the Secretary, register with the Secretary the name and 
place of business of the establishment, the name of the United States 
agent for the establishment, the name of each importer of such drug or 
device in the United States that is known to the establishment, and the 
name of each person who imports or offers for import such drug or device 
to the United States for purposes of importation'' for ``shall register 
with the Secretary the name and place of business of the establishment 
and the name of the United States agent for the establishment''.
    Subsec. (j)(1). Pub. L. 107-188, Sec. 321(a)(2), substituted 
``subsection (b), (c), (d), or (i)'' for ``subsection (b), (c), or (d)'' 
in first sentence.
    Subsec. (m)(1). Pub. L. 107-250, Sec. 211, inserted at end ``The 
Secretary shall publish such list on the Internet site of the Food and 
Drug Administration. The list so published shall be updated not later 
than 30 days after each revision of the list by the Secretary.''
    Subsec. (o). Pub. L. 107-250, Sec. 302(b), added subsec. (o).
    Subsec. (p). Pub. L. 107-250, Sec. 207, added subsec. (p).
    1997--Subsec. (g). Pub. L. 105-115, Sec. 213(b)(3), inserted at end 
``In this subsection, the term `wholesale distributor' means any person 
(other than the manufacturer or the initial importer) who distributes a 
device from the original place of manufacture to the person who makes 
the final delivery or sale of the device to the ultimate consumer or 
user.''
    Subsec. (g)(4), (5). Pub. L. 105-115, Sec. 213(b)(1), (2), added 
par. (4) and redesignated former par. (4) as (5).
    Subsec. (i). Pub. L. 105-115, Sec. 417, amended subsec. (i) 
generally. Prior to amendment, subsec. (i) read as follows: ``Any 
establishment within any foreign country engaged in the manufacture, 
preparation, propagation, compounding, or processing of a drug or drugs, 
or a device or devices, shall be permitted to register under this 
section pursuant to regulations promulgated by the Secretary. Such 
regulations shall require such establishment to provide the information 
required by subsection (j) of this section and shall require such 
establishment to provide the information required by subsection (j) of 
this section in the case of a device or devices and shall include 
provisions for registration of any such establishment upon condition 
that adequate and effective means are available, by arrangement with the 
government of such foreign country or otherwise, to enable the Secretary 
to determine from time to time whether drugs or devices manufactured, 
prepared, propagated, compounded, or processed in such establishment, if 
imported or offered for import into the United States, shall be refused 
admission on any of the grounds set forth in section 381(a) of this 
title.''
    Subsec. (j)(1)(A), (D). Pub. L. 105-115, Sec. 125(a)(2)(C), struck 
out ``, 356, 357,'' before ``or 360b of this title''.
    Subsec. (k). Pub. L. 105-115, Sec. 206(a)(1), inserted ``or person 
who is accredited under section 360m(a) of this title'' after ``report 
to the Secretary''.
    Subsecs. (l), (m). Pub. L. 105-115, Sec. 206(a)(2), added subsecs. 
(l) and (m).
    Subsec. (n). Pub. L. 105-115, Sec. 209(a), added subsec. (n).
    1976--Subsec. (a)(1). Pub. L. 94-295, Sec. 4(a)(2), substituted 
``drug package or device package'' for ``drug package'', ``distribution 
of the drug or device'' for ``distribution of the drug'', and ``ultimate 
consumer or user'' for ``ultimate consumer''.
    Subsecs. (b) to (d). Pub. L. 94-295, Sec. 4(a)(3), inserted ``or a 
device or devices'' after ``drug or drugs''.
    Subsec. (e). Pub. L. 94-295, Sec. 4(a)(4), authorized the Secretary 
to prescribe by regulation a uniform system for the identification of 
devices intended for human use and authorized him, in addition, to 
require that persons who are required to list devices pursuant to 
subsec. (j) also list such devices in accordance with the system.
    Subsec. (g)(1) to (3). Pub. L. 94-295, Sec. 4(a)(5), substituted 
``drugs or devices'' for ``drugs''.
    Subsec. (h). Pub. L. 94-295, Sec. 4(a)(6), inserted reference to 
establishments engaged in the manufacture, propagation, compounding, or 
processing of a drug or drugs or of a device or devices classified in 
class II or III.
    Subsec. (i). Pub. L. 94-295, Sec. 4(a)(7), inserted reference to 
devices and inserted requirement that regulations require establishments 
to provide the information required by subsection (j) of this section in 
the case of a device or devices.
    Subsec. (j)(1). Pub. L. 94-295, Sec. 4(a)(8)(A), in introductory 
provisions substituted ``a list of all drugs and a list of all devices 
and a brief statement of the basis for believing that each device 
included in the list is a device rather than a drug (with each drug and 
device in each list listed by its established name'' for ``a list of all 
drugs (by established name'' and ``drugs or devices filed'' for ``drugs 
filed''.
    Subsec. (j)(1)(A). Pub. L. 94-295, Sec. 4(a)(8)(B), substituted 
``the applicable list'' for ``such list'', inserted ``or a device 
intended for human use contained in the applicable list with respect to 
which a performance standard has been established under section 360d of 
this title or which is subject to section 360e of this title,'' after 
``360b of this title,'', and substituted ``such drug or device'' for 
``such drug'' wherever appearing.
    Subsec. (j)(1)(B). Pub. L. 94-295, Sec. 4(a)(8)(C), in introductory 
provisions substituted ``drug or device contained in an applicable 
list'' for ``drug contained in such list''.
    Subsec. (j)(1)(B)(i). Pub. L. 94-295, Sec. 4(a)(8)(D), substituted 
``which drug is subject to section 353(b)(1) of this title, or which 
device is a restricted device, a copy of all labeling for such drug or 
device, a representative sampling of advertisements for such drug or 
device, and, upon request made by the Secretary for good cause, a copy 
of all advertisements for a particular drug product or device, or'' for 
``which is subject to section 353(b)(1) of this title, a copy of all 
labeling for such drug, a representative sampling of advertisements for 
such drug, and, upon request made by the Secretary for good cause, a 
copy of all advertisements for a particular drug product, or''.
    Subsec. (j)(1)(B)(ii). Pub. L. 94-295, Sec. 4(a)(8)(E), substituted 
``which drug is not subject to section 353(b)(1) of this title or which 
device is not a restricted device, the label and package insert for such 
drug or device and a representative sampling of any other labeling for 
such drug or device'' for ``which is not subject to section 353(b)(1) of 
this title, the label and package insert for such drug and a 
representative sampling of any other labeling for such drug''.
    Subsec. (j)(1)(C). Pub. L. 94-295, Sec. 4(a)(8)(F), substituted ``an 
applicable list'' for ``such list''.
    Subsec. (j)(1)(D). Pub. L. 94-295, Sec. 4(a)(8)(G), substituted ``a 
list'' for ``the list'', inserted ``or the particular device contained 
in such list is not subject to a performance standard established under 
section 360d of this title or to section 360e of this title or is not a 
restricted device'' after ``or 360b of this title,'', and substituted 
``particular drug product or device'' for ``particular drug product'' 
wherever appearing.
    Subsec. (j)(2). Pub. L. 94-295, Sec. 4(a)(8)(H), substituted ``drug 
or ``device'' for ``drug'' in subpars. (A), (B), and (C), and 
substituted ``(each by established name'' for ``(by established name'' 
in subpar. (C).
    Subsec. (k). Pub. L. 94-295, Sec. 4(a)(9), added subsec. (k).
    1972--Subsec. (e). Pub. L. 92-387, Sec. 4(a), inserted provision 
that the Secretary may assign a listing number to each drug or class of 
drugs listed under subsec. (j).
    Subsec. (f). Pub. L. 92-387, Sec. 4(b), inserted exception that the 
list submitted under subsec. (j)(3) and information submitted under 
subsec. (j)(1), (2) shall be exempt from inspection unless the Secretary 
determines otherwise.
    Subsec. (i). Pub. L. 92-387, Sec. 4(c), inserted provision that the 
regulations shall require such establishment to provide the information 
required by subsec. (j).
    Subsec. (j). Pub. L. 92-387, Sec. 3, added subsec. (j).
    1970--Subsec. (a). Pub. L. 91-513 struck out provisions defining the 
wholesaling, jobbing, or distributing of depressant or stimulant drugs.
    Subsec. (b). Pub. L. 91-513 struck out provisions covering 
establishments engaged in the wholesaling, jobbing, or distributing of 
depressant or stimulant drugs and the inclusion of the fact of such 
activity in the annual registration.
    Subsec. (c). Pub. L. 91-513 struck out provisions covering new 
registrations of persons first engaging in the wholesaling, jobbing, or 
distributing of depressant or stimulant drugs and the inclusion of the 
fact of such activity in the registration.
    Subsec. (d). Pub. L. 91-513 struck out number designation ``(1)'' 
preceding first sentence, struck out portion of such redesignated 
provisions covering the wholesaling, jobbing, or distributing of 
depressant or stimulant drugs, and struck out par. (2) covering the 
filing of supplemental registration whenever a person not previously 
engaged or involved with depressant or stimulant drugs goes into the 
manufacturing, preparation, or processing thereof.
    1965--Pub. L. 89-74, Sec. 4(e), included certain wholesalers in 
section catchline.
    Subsec. (a)(2), (3). Pub. L. 89-74, Sec. 4(a), added par. (2) and 
redesignated former par. (2) as (3).
    Subsecs. (b), (c). Pub. L. 89-74, Sec. 4(b), (c), inserted ``or in 
the wholesaling, jobbing, or distributing of any depressant or stimulant 
drug'' after ``drug or drugs'' and inserted requirement that 
establishment indicate activity in depressant or stimulant drugs at time 
of registration.
    Subsec. (d). Pub. L. 89-74 Sec. 4(d), designated existing provisions 
as par. (1), inserted ``or the wholesaling, jobbing, or distributing of 
any depressant or stimulant drug'' and the requirement that the 
additional establishment indicate activity in depressant or stimulant 
drugs at time of registration, and added par. (2).


                    Effective Date of 2002 Amendment

    Amendment by Pub. L. 107-188 effective upon the expiration of the 
180-day period beginning June 12, 2002, see section 321(c) of Pub. L. 
107-188, set out as a note under section 331 of this title.


                    Effective Date of 1997 Amendment

    Amendment by sections 206(a), 209(a), 213(b), and 417 of Pub. L. 
105-115 effective 90 days after Nov. 21, 1997, except as otherwise 
provided, see section 501 of Pub. L. 105-115, set out as a note under 
section 321 of this title.


                    Effective Date of 1972 Amendment

    Section 5 of Pub. L. 92-387 provided that: ``The amendments made by 
this Act [amending this section and sections 331 and 335 of this title 
and enacting provisions set out below] shall take effect on the first 
day of the sixth month beginning after the date of enactment of this Act 
[Aug. 16, 1972].''


                    Effective Date of 1970 Amendment

    Amendment by Pub. L. 91-513 effective on first day of seventh 
calendar month that begins after Oct. 26, 1970, see section 704 of Pub. 
L. 91-513, set out as an Effective Date note under section 801 of this 
title.


                    Effective Date of 1965 Amendment

    Amendment by Pub. L. 89-74 effective Feb. 1, 1966, subject to 
registration with Secretary of names, places of business, 
establishments, and other prescribed information prior to Feb. 1, 1966, 
see section 11 of Pub. L. 89-74, set out as a note under section 321 of 
this title.


                            Savings Provision

    Amendment by Pub. L. 91-513 not to affect or abate any prosecutions 
for any violation of law or any civil seizures or forfeitures and 
injunctive proceedings commenced prior to the effective date of such 
amendment, and all administrative proceedings pending before the Bureau 
of Narcotics and Dangerous Drugs [now the Drug Enforcement 
Administration] on Oct. 27, 1970, to be continued and brought to final 
determination in accord with laws and regulations in effect prior to 
Oct. 27, 1970, see section 702 of Pub. L. 91-513, set out as a note 
under section 321 of this title.


  Congressional Declaration of Need for Registration and Inspection of 
                           Drug Establishments

    Section 301 of Pub. L. 87-781 provided that: ``The Congress hereby 
finds and declares that in order to make regulation of interstate 
commerce in drugs effective, it is necessary to provide for registration 
and inspection of all establishments in which drugs are manufactured, 
prepared, propagated, compounded, or processed; that the products of all 
such establishments are likely to enter the channels of interstate 
commerce and directly affect such commerce; and that the regulation of 
interstate commerce in drugs without provision for registration and 
inspection of establishments that may be engaged only in intrastate 
commerce in such drugs would discriminate against and depress interstate 
commerce in such drugs, and adversely burden, obstruct, and affect such 
interstate commerce.''


            Declaration of Policy of Drug Listing Act of 1972

    Section 2 of Pub. L. 92-387 provided that: ``The Federal Government 
which is responsible for regulating drugs has no ready means of 
determining what drugs are actually being manufactured or packed by 
establishments registered under the Federal Food, Drug, and Cosmetic Act 
[this chapter] except by periodic inspection of such registered 
establishments. Knowledge of which particular drugs are being 
manufactured or packed by each registered establishment would 
substantially assist in the enforcement of Federal laws requiring that 
such drugs be pure, safe, effective, and properly labeled. Information 
on the discontinuance of a particular drug could serve to alleviate the 
burden of reviewing and implementing enforcement actions against drugs 
which, although commercially discontinued, remain active for regulatory 
purposes. Information on the type and number of different drugs being 
manufactured or packed by drug establishments could permit more 
effective and timely regulation by the agencies of the Federal 
Government responsible for regulating drugs, including identification of 
which drugs in interstate commerce are subject to section 505 or 507 
[section 355 or 357 of this title], or to other provisions of the 
Federal Food, Drug, and Cosmetic Act.''


Registration of Certain Persons Owning or Operating Drug Establishments 
                         Prior to Oct. 10, 1962

    Section 303 of Pub. L. 87-781 provided that any person who, on the 
day immediately preceding Oct. 10, 1962, owned or operated an 
establishment which manufactured or processed drugs, registered before 
the first day of the seventh month following October, 1962, would be 
deemed to be registered in accordance with subsec. (b) of this section 
for the calendar year 1962 and if registered within this period and 
effected in 1963, be deemed in compliance for that calendar year.

                  Section Referred to in Other Sections

    This section is referred to in sections 331, 352, 353a, 355, 360c, 
360e, 360i, 360j, 360m, 374, 379h, 379i, 381, 1602, 1604, 1605 of this 
title; title 42 section 1395l.