21 U.S.C. § 360 : US Code - Section 360: Registration of producers of drugs or devices

Search 21 U.S.C. § 360 : US Code - Section 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 or 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 or 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
semi-critical 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.