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26 U.S.C. § 223 — Health savings accounts
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Page 969
TITLE 26—INTERNAL REVENUE CODE
§ 223
EFFECTIVE DATE OF 2004 AMENDMENTS
Amendment by Pub. L. 108–357 applicable to taxable
years beginning after Dec. 31, 2004, see section 102(e) of
Pub. L. 108–357, set out as a note under section 56 of
this title.
Amendment by section 207(20) of Pub. L. 108–311 appli-
cable to taxable years beginning after Dec. 31, 2004, see
section 208 of Pub. L. 108–311, set out as a note under
section 2 of this title.
EFFECTIVE DATE OF 2001 AMENDMENT
Amendment by section 402(b)(2)(B) of Pub. L. 107–16
applicable to taxable years beginning after Dec. 31,
2001, see section 402(h) of Pub. L. 107–16, set out as a
note under section 72 of this title.
Pub. L. 107–16, title IV, § 412(a)(3), June 7, 2001, 115
Stat. 64, provided that: ‘‘The amendments made by this
subsection [amending this section and section 6050S of
this title] shall apply with respect to any loan interest
paid after December 31, 2001, in taxable years ending
after such date.’’
Pub. L. 107–16, title IV, § 412(b)(3), June 7, 2001, 115
Stat. 64, provided that: ‘‘The amendments made by this
subsection [amending this section] shall apply to tax-
able years ending after December 31, 2001.’’
Amendment by section 431(c)(2) of Pub. L. 107–16 ap-
plicable to payments made in taxable years beginning
after Dec. 31, 2001, see section 431(d) of Pub. L. 107–16,
set out as a note under section 62 of this title.
EFFECTIVE DATE OF 1998 AMENDMENTS
Amendment by Pub. L. 105–277 effective as if included
in the provision of the Taxpayer Relief Act of 1997, Pub.
L. 105–34, to which such amendment relates, see section
4003(l) of Pub. L. 105–277, set out as a note under section
86 of this title.
Amendment by Pub. L. 105–206 effective, except as
otherwise provided, as if includ
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Page 969
TITLE 26—INTERNAL REVENUE CODE
§ 223
EFFECTIVE DATE OF 2004 AMENDMENTS
Amendment by Pub. L. 108–357 applicable to taxable
years beginning after Dec. 31, 2004, see section 102(e) of
Pub. L. 108–357, set out as a note under section 56 of
this title.
Amendment by section 207(20) of Pub. L. 108–311 appli-
cable to taxable years beginning after Dec. 31, 2004, see
section 208 of Pub. L. 108–311, set out as a note under
section 2 of this title.
EFFECTIVE DATE OF 2001 AMENDMENT
Amendment by section 402(b)(2)(B) of Pub. L. 107–16
applicable to taxable years beginning after Dec. 31,
2001, see section 402(h) of Pub. L. 107–16, set out as a
note under section 72 of this title.
Pub. L. 107–16, title IV, § 412(a)(3), June 7, 2001, 115
Stat. 64, provided that: ‘‘The amendments made by this
subsection [amending this section and section 6050S of
this title] shall apply with respect to any loan interest
paid after December 31, 2001, in taxable years ending
after such date.’’
Pub. L. 107–16, title IV, § 412(b)(3), June 7, 2001, 115
Stat. 64, provided that: ‘‘The amendments made by this
subsection [amending this section] shall apply to tax-
able years ending after December 31, 2001.’’
Amendment by section 431(c)(2) of Pub. L. 107–16 ap-
plicable to payments made in taxable years beginning
after Dec. 31, 2001, see section 431(d) of Pub. L. 107–16,
set out as a note under section 62 of this title.
EFFECTIVE DATE OF 1998 AMENDMENTS
Amendment by Pub. L. 105–277 effective as if included
in the provision of the Taxpayer Relief Act of 1997, Pub.
L. 105–34, to which such amendment relates, see section
4003(l) of Pub. L. 105–277, set out as a note under section
86 of this title.
Amendment by Pub. L. 105–206 effective, except as
otherwise provided, as if included in the provisions of
the Taxpayer Relief Act of 1997, Pub. L. 105–34, to which
such amendment relates, see section 6024 of Pub. L.
105–206, set out as a note under section 1 of this title.
EFFECTIVE DATE
Section applicable to any qualified education loan (as
defined in subsec. (e)(1) of this section) incurred on, be-
fore, or after Aug. 5, 1997, but only with respect to any
loan interest payment due and paid after Dec. 31, 1997,
and to the portion of the 60-month period referred to in
subsec. (d) of this section after Dec. 31, 1997, see section
202(e) of Pub. L. 105–34, set out as an Effective Date of
1997 Amendment note under section 62 of this title.
[§ 222. Repealed. Pub. L. 116–260, div. EE, title I,
§ 104(b)(1), Dec. 27, 2020, 134 Stat. 3041]
Section, added Pub. L. 107–16, title IV, § 431(a), June 7,
2001, 115 Stat. 66; amended Pub. L. 108–357, title I,
§ 102(d)(3), Oct. 22, 2004, 118 Stat. 1429; Pub. L. 109–432,
div. A, title I, § 101(a), (b), Dec. 20, 2006, 120 Stat. 2933;
Pub. L. 110–343, div. C, title II, § 202(a), Oct. 3, 2008, 122
Stat. 3864; Pub. L. 111–312, title VII, § 724(a), Dec. 17,
2010, 124 Stat. 3316; Pub. L. 112–240, title II, § 207(a), Jan.
2, 2013, 126 Stat. 2324; Pub. L. 113–295, div. A, title I,
§ 107(a), Dec. 19, 2014, 128 Stat. 4013; Pub. L. 114–27, title
VIII, § 804(b), June 29, 2015, 129 Stat. 415; Pub. L. 114–113,
div. Q, title I, § 153(a), Dec. 18, 2015, 129 Stat. 3066; Pub.
L. 115–97, title I, § 13305(b)(1), Dec. 22, 2017, 131 Stat. 2126;
Pub. L. 115–123, div. D, title I, § 40203(a), Feb. 9, 2018, 132
Stat. 145; Pub. L. 116–94, div. Q, title I, § 104(a), Dec. 20,
2019, 133 Stat. 3228; Pub. L. 117–2, title IX, § 9042(b)(7),
Mar. 11, 2021, 135 Stat. 122, related to a deduction for
qualified tuition and related expenses.
A prior section 222 was renumbered section 224 of this
title.
Another prior section 222, added Pub. L. 97–34, title I,
§ 125(a), Aug. 13, 1981, 95 Stat. 201; amended Pub. L.
97–448, title I, § 101(f), Jan. 12, 1983, 96 Stat. 2367, related
to deduction of adoption expenses, prior to repeal by
Pub. L. 99–514, title I, §§ 135(a), 151(a), Oct. 22, 1986, 100
Stat. 2116, 2121, applicable to taxable years beginning
after Dec. 31, 1986.
Statutory Notes and Related Subsidiaries
EFFECTIVE DATE OF REPEAL
Repeal of section applicable to taxable years begin-
ning after Dec. 31, 2020, see section 104(c) of div. EE of
Pub. L. 116–260, set out as an Effective Date of 2020
Amendment note under section 25A of this title.
§ 223. Health savings accounts
(a) Deduction allowed
In the case of an individual who is an eligible
individual for any month during the taxable
year, there shall be allowed as a deduction for
the taxable year an amount equal to the aggre-
gate amount paid in cash during such taxable
year by or on behalf of such individual to a
health savings account of such individual.
(b) Limitations
(1) In general
The amount allowable as a deduction under
subsection (a) to an individual for the taxable
year shall not exceed the sum of the monthly
limitations for months during such taxable
year that the individual is an eligible indi-
vidual.
(2) Monthly limitation
The monthly limitation for any month is 1⁄12
of—
(A) in the case of an eligible individual
who has self-only coverage under a high de-
ductible health plan as of the first day of
such month, $2,250.
(B) in the case of an eligible individual
who has family coverage under a high de-
ductible health plan as of the first day of
such month, $4,500.
(3) Additional contributions for individuals 55
or older
(A) In general
In the case of an individual who has at-
tained age 55 before the close of the taxable
year, the applicable limitation under sub-
paragraphs (A) and (B) of paragraph (2) shall
be increased by the additional contribution
amount.
(B) Additional contribution amount
For purposes of this section, the additional
contribution amount is the amount deter-
mined in accordance with the following
table:
For taxable years beginning in:
The additional
contribution
amount is:
2004 .............................................
$500
2005 .............................................
$600
2006 .............................................
$700
2007 .............................................
$800
2008 .............................................
$900
2009 and thereafter .....................
$1,000.
(4) Coordination with other contributions
The limitation which would (but for this
paragraph) apply under this subsection to an
individual for any taxable year shall be re-
duced (but not below zero) by the sum of—
Page 970
TITLE 26—INTERNAL REVENUE CODE
§ 223
(A) the aggregate amount paid for such
taxable year to Archer MSAs of such indi-
vidual,
(B) the aggregate amount contributed to
health savings accounts of such individual
which is excludable from the taxpayer’s
gross income for such taxable year under
section 106(d) (and such amount shall not be
allowed as a deduction under subsection (a)),
and
(C) the aggregate amount contributed to
health savings accounts of such individual
for such taxable year under section 408(d)(9)
(and such amount shall not be allowed as a
deduction under subsection (a)).
Subparagraph (A) shall not apply with respect
to any individual to whom paragraph (5) ap-
plies.
(5) Special rule for married individuals
In the case of individuals who are married to
each other, if either spouse has family cov-
erage—
(A) both spouses shall be treated as having
only such family coverage (and if such
spouses each have family coverage under dif-
ferent plans, as having the family coverage
with the lowest annual deductible), and
(B) the limitation under paragraph (1)
(after the application of subparagraph (A)
and without regard to any additional con-
tribution amount under paragraph (3))—
(i) shall be reduced by the aggregate
amount paid to Archer MSAs of such
spouses for the taxable year, and
(ii) after such reduction, shall be divided
equally between them unless they agree on
a different division.
(6) Denial of deduction to dependents
No deduction shall be allowed under this sec-
tion to any individual with respect to whom a
deduction under section 151 is allowable to an-
other taxpayer for a taxable year beginning in
the calendar year in which such individual’s
taxable year begins.
(7) Medicare eligible individuals
The limitation under this subsection for any
month with respect to an individual shall be
zero for the first month such individual is en-
titled to benefits under title XVIII of the So-
cial Security Act and for each month there-
after.
(8) Increase in limit for individuals becoming
eligible individuals after the beginning of
the year
(A) In general
For purposes of computing the limitation
under paragraph (1) for any taxable year, an
individual who is an eligible individual dur-
ing the last month of such taxable year shall
be treated—
(i) as having been an eligible individual
during each of the months in such taxable
year, and
(ii) as having been enrolled, during each
of the months such individual is treated as
an eligible individual solely by reason of
clause (i), in the same high deductible
health plan in which the individual was
enrolled for the last month of such taxable
year.
(B) Failure to maintain high deductible
health plan coverage
(i) In general
If, at any time during the testing period,
the individual is not an eligible individual,
then—
(I) gross income of the individual for
the taxable year in which occurs the
first month in the testing period for
which such individual is not an eligible
individual is increased by the aggregate
amount of all contributions to the
health savings account of the individual
which could not have been made but for
subparagraph (A), and
(II) the tax imposed by this chapter for
any taxable year on the individual shall
be increased by 10 percent of the amount
of such increase.
(ii) Exception for disability or death
Subclauses (I) and (II) of clause (i) shall
not apply if the individual ceased to be an
eligible individual by reason of the death
of the individual or the individual becom-
ing disabled (within the meaning of sec-
tion 72(m)(7)).
(iii) Testing period
The term ‘‘testing period’’ means the pe-
riod beginning with the last month of the
taxable year referred to in subparagraph
(A) and ending on the last day of the 12th
month following such month.
(c) Definitions and special rules
For purposes of this section—
(1) Eligible individual
(A) In general
The term ‘‘eligible individual’’ means,
with respect to any month, any individual
if—
(i) such individual is covered under a
high deductible health plan as of the 1st
day of such month, and
(ii) such individual is not, while covered
under a high deductible health plan, cov-
ered under any health plan—
(I) which is not a high deductible
health plan, and
(II) which provides coverage for any
benefit which is covered under the high
deductible health plan.
(B) Certain coverage disregarded
Subparagraph (A)(ii) shall be applied with-
out regard to—
(i) coverage for any benefit provided by
permitted insurance,
(ii) coverage (whether through insurance
or otherwise) for accidents, disability, den-
tal care, vision care, long-term care, or (in
the case of months or plan years to which
paragraph (2)(E) applies) telehealth and
other remote care, and
(iii) for taxable years beginning after De-
cember 31, 2006, coverage under a health
flexible spending arrangement during any
Page 971
TITLE 26—INTERNAL REVENUE CODE
§ 223
period immediately following the end of a
plan year of such arrangement during
which unused benefits or contributions re-
maining at the end of such plan year may
be paid or reimbursed to plan participants
for qualified benefit expenses incurred dur-
ing such period if—
(I) the balance in such arrangement at
the end of such plan year is zero, or
(II) the individual is making a quali-
fied HSA distribution (as defined in sec-
tion 106(e)) in an amount equal to the re-
maining balance in such arrangement as
of the end of such plan year, in accord-
ance with rules prescribed by the Sec-
retary.
(C) Special rule for individuals eligible for
certain veterans benefits
An individual shall not fail to be treated
as an eligible individual for any period mere-
ly because the individual receives hospital
care or medical services under any law ad-
ministered by the Secretary of Veterans Af-
fairs for a service-connected disability (with-
in the meaning of section 101(16) of title 38,
United States Code).
(D) Special rule for individuals receiving
benefits subject to surprise billing stat-
utes
An individual shall not fail to be treated
as an eligible individual for any period mere-
ly because the individual receives benefits
for medical care subject to and in accord-
ance with section 9816 or 9817, section
2799A–1 or 2799A–2 of the Public Health Serv-
ice Act, or section 716 or 717 of the Employee
Retirement Income Security Act of 1974, or
any State law providing similar protections
to such individual.
(2) High deductible health plan
(A) In general
The term ‘‘high deductible health plan’’
means a health plan—
(i) which has an annual deductible which
is not less than—
(I) $1,000 for self-only coverage, and
(II) twice the dollar amount in sub-
clause (I) for family coverage, and
(ii) the sum of the annual deductible and
the other annual out-of-pocket expenses
required to be paid under the plan (other
than for premiums) for covered benefits
does not exceed—
(I) $5,000 for self-only coverage, and
(II) twice the dollar amount in sub-
clause (I) for family coverage.
(B) Exclusion of certain plans
Such term does not include a health plan
if substantially all of its coverage is cov-
erage described in paragraph (1)(B).
(C) Safe harbor for absence of preventive
care deductible
A plan shall not fail to be treated as a high
deductible health plan by reason of failing to
have a deductible for preventive care (within
the meaning of section 1861 of the Social Se-
curity Act, except as otherwise provided by
the Secretary).
(D) Special rules for network plans
In the case of a plan using a network of
providers—
(i) Annual out-of-pocket limitation
Such plan shall not fail to be treated as
a high deductible health plan by reason of
having an out-of-pocket limitation for
services provided outside of such network
which exceeds the applicable limitation
under subparagraph (A)(ii).
(ii) Annual deductible
Such plan’s annual deductible for serv-
ices provided outside of such network shall
not be taken into account for purposes of
subsection (b)(2).
(E) Safe harbor for absence of deductible for
telehealth
In the case of—
(i) months beginning after March 31,
2022, and before January 1, 2023, and
(ii) plan years beginning on or before De-
cember 31, 2021, or after December 31, 2022,
and before January 1, 2025,
a plan shall not fail to be treated as a high
deductible health plan by reason of failing to
have a deductible for telehealth and other
remote care services.
(F) Special rule for surprise billing
A plan shall not fail to be treated as a high
deductible health plan by reason of pro-
viding benefits for medical care in accord-
ance with section 9816 or 9817, section
2799A–1 or 2799A–2 of the Public Health Serv-
ice Act, or section 716 or 717 of the Employee
Retirement Income Security Act of 1974, or
any State law providing similar protections
to individuals, prior to the satisfaction of
the deductible under paragraph (2)(A)(i).
(G) Safe harbor for absence of deductible for
certain insulin products
(i) In general
A plan shall not fail to be treated as a
high deductible health plan by reason of
failing to have a deductible for selected in-
sulin products.
(ii) Selected insulin products
For purposes of this subparagraph—
(I) In general
The term ‘‘selected insulin products’’
means any dosage form (such as vial,
pump, or inhaler dosage forms) of any
different type (such as rapid-acting,
short-acting, intermediate-acting, long-
acting, ultra long-acting, and premixed)
of insulin.
(II) Insulin
The term ‘‘insulin’’ means insulin that
is licensed under subsection (a) or (k) of
section 351 of the Public Health Service
Act (42 U.S.C. 262) and continues to be
marketed under such section, including
any
insulin
product
that
has
been
deemed to be licensed under section
351(a) of such Act pursuant to section
7002(e)(4) of the Biologics Price Competi-
Page 972
TITLE 26—INTERNAL REVENUE CODE
§ 223
tion and Innovation Act of 2009 (Public
Law 111–148) and continues to be mar-
keted pursuant to such licensure.
(3) Permitted insurance
The term ‘‘permitted insurance’’ means—
(A) insurance if substantially all of the
coverage provided under such insurance re-
lates to—
(i) liabilities incurred under workers’
compensation laws,
(ii) tort liabilities,
(iii) liabilities relating to ownership or
use of property, or
(iv) such other similar liabilities as the
Secretary may specify by regulations,
(B) insurance for a specified disease or ill-
ness, and
(C) insurance paying a fixed amount per
day (or other period) of hospitalization.
(4) Family coverage
The term ‘‘family coverage’’ means any cov-
erage other than self-only coverage.
(5) Archer MSA
The term ‘‘Archer MSA’’ has the meaning
given such term in section 220(d).
(d) Health savings account
For purposes of this section—
(1) In general
The term ‘‘health savings account’’ means a
trust created or organized in the United States
as a health savings account exclusively for the
purpose of paying the qualified medical ex-
penses of the account beneficiary, but only if
the written governing instrument creating the
trust meets the following requirements:
(A) Except in the case of a rollover con-
tribution described in subsection (f)(5) or
section 220(f)(5), no contribution will be ac-
cepted—
(i) unless it is in cash, or
(ii) to the extent such contribution,
when added to previous contributions to
the trust for the calendar year, exceeds the
sum of—
(I) the dollar amount in effect under
subsection (b)(2)(B), and
(II) the dollar amount in effect under
subsection (b)(3)(B).
(B) The trustee is a bank (as defined in
section 408(n)), an insurance company (as de-
fined in section 816), or another person who
demonstrates to the satisfaction of the Sec-
retary that the manner in which such person
will administer the trust will be consistent
with the requirements of this section.
(C) No part of the trust assets will be in-
vested in life insurance contracts.
(D) The assets of the trust will not be com-
mingled with other property except in a
common trust fund or common investment
fund.
(E) The interest of an individual in the
balance in his account is nonforfeitable.
(2) Qualified medical expenses
(A) In general
The term ‘‘qualified medical expenses’’
means, with respect to an account bene-
ficiary, amounts paid by such beneficiary for
medical care (as defined in section 213(d)) for
such individual, the spouse of such indi-
vidual, and any dependent (as defined in sec-
tion 152, determined without regard to sub-
sections (b)(1), (b)(2), and (d)(1)(B) thereof) of
such individual, but only to the extent such
amounts are not compensated for by insur-
ance or otherwise. For purposes of this sub-
paragraph, amounts paid for menstrual care
products shall be treated as paid for medical
care.
(B) Health insurance may not be purchased
from account
Subparagraph (A) shall not apply to any
payment for insurance.
(C) Exceptions
Subparagraph (B) shall not apply to any
expense for coverage under—
(i) a health plan during any period of
continuation coverage required under any
Federal law,
(ii) a qualified long-term care insurance
contract (as defined in section 7702B(b)),
(iii) a health plan during a period in
which the individual is receiving unem-
ployment compensation under any Federal
or State law, or
(iv) in the case of an account beneficiary
who has attained the age specified in sec-
tion 1811 of the Social Security Act, any
health insurance other than a medicare
supplemental policy (as defined in section
1882 of the Social Security Act).
(D) Menstrual care product
For purposes of this paragraph, the term
‘‘menstrual care product’’ means a tampon,
pad, liner, cup, sponge, or similar product
used by individuals with respect to men-
struation or other genital-tract secretions.
(3) Account beneficiary
The term ‘‘account beneficiary’’ means the
individual on whose behalf the health savings
account was established.
(4) Certain rules to apply
Rules similar to the following rules shall
apply for purposes of this section:
(A) Section 219(d)(2) (relating to no deduc-
tion for rollovers).
(B) Section 219(f)(3) (relating to time when
contributions deemed made).
(C) Except as provided in section 106(d),
section 219(f)(5) (relating to employer pay-
ments).
(D) Section 408(g) (relating to community
property laws).
(E) Section 408(h) (relating to custodial ac-
counts).
(e) Tax treatment of accounts
(1) In general
A health savings account is exempt from
taxation under this subtitle unless such ac-
count has ceased to be a health savings ac-
count. Notwithstanding the preceding sen-
tence, any such account is subject to the taxes
imposed by section 511 (relating to imposition
of tax on unrelated business income of chari-
table, etc. organizations).
Page 973
TITLE 26—INTERNAL REVENUE CODE
§ 223
(2) Account terminations
Rules similar to the rules of paragraphs (2)
and (4) of section 408(e) shall apply to health
savings accounts, and any amount treated as
distributed under such rules shall be treated
as not used to pay qualified medical expenses.
(f) Tax treatment of distributions
(1) Amounts used for qualified medical ex-
penses
Any amount paid or distributed out of a
health savings account which is used exclu-
sively to pay qualified medical expenses of any
account beneficiary shall not be includible in
gross income.
(2) Inclusion of amounts not used for qualified
medical expenses
Any amount paid or distributed out of a
health savings account which is not used ex-
clusively to pay the qualified medical ex-
penses of the account beneficiary shall be in-
cluded in the gross income of such beneficiary.
(3) Excess contributions returned before due
date of return
(A) In general
If any excess contribution is contributed
for a taxable year to any health savings ac-
count of an individual, paragraph (2) shall
not apply to distributions from the health
savings accounts of such individual (to the
extent such distributions do not exceed the
aggregate excess contributions to all such
accounts of such individual for such year)
if—
(i) such distribution is received by the
individual on or before the last day pre-
scribed by law (including extensions of
time) for filing such individual’s return for
such taxable year, and
(ii) such distribution is accompanied by
the amount of net income attributable to
such excess contribution.
Any net income described in clause (ii) shall
be included in the gross income of the indi-
vidual for the taxable year in which it is re-
ceived.
(B) Excess contribution
For purposes of subparagraph (A), the term
‘‘excess contribution’’ means any contribu-
tion (other than a rollover contribution de-
scribed in paragraph (5) or section 220(f)(5))
which is neither excludable from gross in-
come under section 106(d) nor deductible
under this section.
(4) Additional tax on distributions not used for
qualified medical expenses
(A) In general
The tax imposed by this chapter on the ac-
count beneficiary for any taxable year in
which there is a payment or distribution
from a health savings account of such bene-
ficiary which is includible in gross income
under paragraph (2) shall be increased by 20
percent of the amount which is so includible.
(B) Exception for disability or death
Subparagraph (A) shall not apply if the
payment or distribution is made after the
account beneficiary becomes disabled within
the meaning of section 72(m)(7) or dies.
(C) Exception for distributions after medi-
care eligibility
Subparagraph (A) shall not apply to any
payment or distribution after the date on
which the account beneficiary attains the
age specified in section 1811 of the Social Se-
curity Act.
(5) Rollover contribution
An amount is described in this paragraph as
a rollover contribution if it meets the require-
ments of subparagraphs (A) and (B).
(A) In general
Paragraph (2) shall not apply to any
amount paid or distributed from a health
savings account to the account beneficiary
to the extent the amount received is paid
into a health savings account for the benefit
of such beneficiary not later than the 60th
day after the day on which the beneficiary
receives the payment or distribution.
(B) Limitation
This paragraph shall not apply to any
amount described in subparagraph (A) re-
ceived by an individual from a health sav-
ings account if, at any time during the 1-
year period ending on the day of such re-
ceipt, such individual received any other
amount described in subparagraph (A) from
a health savings account which was not in-
cludible in the individual’s gross income be-
cause of the application of this paragraph.
(6) Coordination with medical expense deduc-
tion
For purposes of determining the amount of
the deduction under section 213, any payment
or distribution out of a health savings account
for qualified medical expenses shall not be
treated as an expense paid for medical care.
(7) Transfer of account incident to divorce
The transfer of an individual’s interest in a
health savings account to an individual’s
spouse or former spouse under a divorce or
separation instrument described in clause (i)
of section 121(d)(3)(C) shall not be considered a
taxable transfer made by such individual not-
withstanding any other provision of this sub-
title, and such interest shall, after such trans-
fer, be treated as a health savings account
with respect to which such spouse is the ac-
count beneficiary.
(8) Treatment after death of account bene-
ficiary
(A) Treatment if designated beneficiary is
spouse
If the account beneficiary’s surviving
spouse acquires such beneficiary’s interest
in a health savings account by reason of
being the designated beneficiary of such ac-
count at the death of the account bene-
ficiary, such health savings account shall be
treated as if the spouse were the account
beneficiary.
(B) Other cases
(i) In general
If, by reason of the death of the account
beneficiary, any person acquires the ac-
Page 974
TITLE 26—INTERNAL REVENUE CODE
§ 223
count beneficiary’s interest in a health
savings account in a case to which sub-
paragraph (A) does not apply—
(I) such account shall cease to be a
health savings account as of the date of
death, and
(II) an amount equal to the fair market
value of the assets in such account on
such date shall be includible if such per-
son is not the estate of such beneficiary,
in such person’s gross income for the
taxable year which includes such date, or
if such person is the estate of such bene-
ficiary, in such beneficiary’s gross in-
come for the last taxable year of such
beneficiary.
(ii) Special rules
(I) Reduction of inclusion for predeath
expenses
The amount includible in gross income
under clause (i) by any person (other
than the estate) shall be reduced by the
amount of qualified medical expenses
which were incurred by the decedent be-
fore the date of the decedent’s death and
paid by such person within 1 year after
such date.
(II) Deduction for estate taxes
An appropriate deduction shall be al-
lowed under section 691(c) to any person
(other than the decedent or the dece-
dent’s spouse) with respect to amounts
included in gross income under clause (i)
by such person.
(g) Cost-of-living adjustment
(1) In general
Each dollar amount in subsections (b)(2) and
(c)(2)(A) shall be increased by an amount equal
to—
(A) such dollar amount, multiplied by
(B) the cost-of-living adjustment deter-
mined under section 1(f)(3) for the calendar
year in which such taxable year begins de-
termined by substituting for ‘‘calendar year
2016’’ in subparagraph (A)(ii) thereof—
(i) except as provided in clause (ii), ‘‘cal-
endar year 1997’’, and
(ii) in the case of each dollar amount in
subsection (c)(2)(A), ‘‘calendar year 2003’’.
In the case of adjustments made for any tax-
able year beginning after 2007, section 1(f)(4)
shall be applied for purposes of this paragraph
by substituting ‘‘March 31’’ for ‘‘August 31’’,
and the Secretary shall publish the adjusted
amounts under subsections (b)(2) and (c)(2)(A)
for taxable years beginning in any calendar
year no later than June 1 of the preceding cal-
endar year.
(2) Rounding
If any increase under paragraph (1) is not a
multiple of $50, such increase shall be rounded
to the nearest multiple of $50.
(h) Reports
The Secretary may require—
(1) the trustee of a health savings account to
make such reports regarding such account to
the Secretary and to the account beneficiary
with respect to contributions, distributions,
the return of excess contributions, and such
other matters as the Secretary determines ap-
propriate, and
(2) any person who provides an individual
with a high deductible health plan to make
such reports to the Secretary and to the ac-
count beneficiary with respect to such plan as
the Secretary determines appropriate.
The reports required by this subsection shall be
filed at such time and in such manner and fur-
nished to such individuals at such time and in
such manner as may be required by the Sec-
retary.
(Added Pub. L. 108–173, title XII, § 1201(a), Dec. 8,
2003, 117 Stat. 2469; amended Pub. L. 109–135, title
IV, § 404(c), Dec. 21, 2005, 119 Stat. 2634; Pub. L.
109–432, div. A, title III, §§ 302(b), 303(a), (b), 304,
305(a), 307(b), Dec. 20, 2006, 120 Stat. 2949, 2950,
2953; Pub. L. 111–148, title IX, §§ 9003(a), 9004(a),
Mar. 23, 2010, 124 Stat. 854; Pub. L. 114–41, title
IV, § 4007(b)(1), July 31, 2015, 129 Stat. 466; Pub. L.
115–97, title I, §§ 11002(d)(1)(V), 11051(b)(3)(E), Dec.
22, 2017, 131 Stat. 2060, 2090; Pub. L. 115–141, div.
U, title IV, § 401(a)(57), (58), Mar. 23, 2018, 132
Stat. 1186, 1187; Pub. L. 116–136, div. A, title III,
§§ 3701(a), (b), 3702(a), Mar. 27, 2020, 134 Stat. 415,
416; Pub. L. 116–260, div. BB, title I, § 102(c)(4)(A),
Dec. 27, 2020, 134 Stat. 2796; Pub. L. 117–103, div.
P, title II, § 307(a), (b), Mar. 15, 2022, 136 Stat. 807;
Pub. L. 117–169, title I, § 11408(a), Aug. 16, 2022,
136 Stat. 1905; Pub. L. 117–328, div. FF, title IV,
§ 4151(a), (b), Dec. 29, 2022, 136 Stat. 5931.)
INFLATION ADJUSTED ITEMS FOR CERTAIN YEARS
For inflation adjustment of certain items in
this section, see Revenue Procedures listed in a
table below and under section 1 of this title.
Editorial Notes
REFERENCES IN TEXT
The Social Security Act, referred to in subsecs. (b)(7),
(c)(2)(C), (d)(2)(C)(iv), and (f)(4)(C), is act Aug. 14, 1935,
ch. 531, 49 Stat. 620. Title XVIII of the Act is classified
generally to subchapter XVIII (§ 1395 et seq.) of chapter
7 of Title 42, The Public Health and Welfare. Sections
1811, 1861, and 1882 of the Act are classified to sections
1395c, 1395x, and 1395ss, respectively, of Title 42. For
complete classification of this Act to the Code, see sec-
tion 1305 of Title 42 and Tables.
Sections 2799A–1 and 2799A–2 of the Public Health
Service Act, referred to in subsec. (c)(1)(D), (2)(F), are
classified to sections 300gg–111 and 300gg–112, respec-
tively, of Title 42, The Public Health and Welfare.
Sections 716 and 717 of the Employee Retirement In-
come Security Act of 1974, referred to in subsec.
(c)(1)(D), (2)(F), are classified to sections 1185e and
1185f, respectively, of Title 29, Labor.
Section 7002(e)(4) of the Biologics Price Competition
and Innovation Act of 2009, referred to in subsec.
(c)(2)(G)(ii)(II), is section 7002(e)(4) of Pub. L. 111–148,
which is set out in a note under section 262 of Title 42,
The Public Health and Welfare.
PRIOR PROVISIONS
A prior section 223 was renumbered section 224 of this
title.
AMENDMENTS
2022—Subsec. (c)(1)(B)(ii). Pub. L. 117–328, § 4151(b),
which directed the substitution of ‘‘(in the case of
months or plan years to which paragraph (2)(E) ap-
Page 975
TITLE 26—INTERNAL REVENUE CODE
§ 223
plies)’’ for ‘‘(in the case of plan years beginning on or
before December 31, 2021, or in the case of months be-
ginning after March 31, 2022, and before January 1,
2023)’’, was executed by making the substitution for
‘‘(in the case of plan years beginning on or before De-
cember 31, 2021, or in the case of months beginning
after March 31, 2022, and before January 1, 2023,)’’, to re-
flect the probable intent of Congress.
Pub. L. 117–103, § 307(b), inserted ‘‘, or in the case of
months beginning after March 31, 2022, and before Janu-
ary 1, 2023,’’ after ‘‘December 31, 2021’’.
Subsec. (c)(2)(E). Pub. L. 117–328, § 4151(a), substituted
‘‘In the case of—’’ and cls. (i) and (ii) for ‘‘In the case
of plan years beginning on or before December 31, 2021,
or in the case of months beginning after March 31, 2022,
and before January 1, 2023,’’.
Pub. L. 117–103, § 307(a), inserted ‘‘or in the case of
months beginning after March 31, 2022, and before Janu-
ary 1, 2023,’’ after ‘‘December 31, 2021,’’.
Subsec. (c)(2)(G). Pub. L. 117–169 added subpar. (G).
2020—Subsec. (c)(1)(B)(ii). Pub. L. 116–136, § 3701(b),
substituted ‘‘long-term care, or (in the case of plan
years beginning on or before December 31, 2021) tele-
health and other remote care’’ for ‘‘or long-term care’’.
Subsec. (c)(1)(D). Pub. L. 116–260, § 102(c)(4)(A)(i),
added subpar. (D).
Subsec. (c)(2)(E). Pub. L. 116–136, § 3701(a), added sub-
par. (E).
Subsec. (c)(2)(F). Pub. L. 116–260, § 102(c)(4)(A)(ii),
added subpar. (F).
Subsec. (d)(2)(A). Pub. L. 116–136, § 3702(a)(1), sub-
stituted ‘‘For purposes of this subparagraph, amounts
paid for menstrual care products shall be treated as
paid for medical care.’’ for ‘‘Such term shall include an
amount paid for medicine or a drug only if such medi-
cine or drug is a prescribed drug (determined without
regard to whether such drug is available without a pre-
scription) or is insulin.’’
Subsec. (d)(2)(D). Pub. L. 116–136, § 3702(a)(2), added
subpar. (D).
2018—Subsec. (c)(2)(C). Pub. L. 115–141, § 401(a)(57),
substituted ‘‘section 1861’’ for ‘‘section 1871’’.
Subsec. (d)(2)(A). Pub. L. 115–141, § 401(a)(58), sub-
stituted ‘‘section 213(d))’’ for ‘‘section 213(d)’’.
2017—Subsec. (f)(7). Pub. L. 115–97, § 11051(b)(3)(E), sub-
stituted ‘‘clause (i) of section 121(d)(3)(C)’’ for ‘‘sub-
paragraph (A) of section 71(b)(2)’’.
Subsec. (g)(1)(B). Pub. L. 115–97, § 11002(d)(1)(V), sub-
stituted ‘‘for ‘calendar year 2016’ in subparagraph
(A)(ii)’’ for ‘‘for ‘calendar year 1992’ in subparagraph
(B)’’ in introductory provisions.
2015—Subsec. (c)(1)(C). Pub. L. 114–41 added subpar.
(C).
2010—Subsec. (d)(2)(A). Pub. L. 111–148, § 9003(a), in-
serted at end ‘‘Such term shall include an amount paid
for medicine or a drug only if such medicine or drug is
a prescribed drug (determined without regard to wheth-
er such drug is available without a prescription) or is
insulin.’’
Subsec. (f)(4)(A). Pub. L. 111–148, § 9004(a), substituted
‘‘20 percent’’ for ‘‘10 percent’’.
2006—Subsec. (b)(2)(A). Pub. L. 109–432, § 303(a)(1), sub-
stituted ‘‘$2,250.’’ for ‘‘the lesser of—
‘‘(i) the annual deductible under such coverage, or
‘‘(ii) $2,250, or’’.
Subsec. (b)(2)(B). Pub. L. 109–432, § 303(a)(2), sub-
stituted ‘‘$4,500.’’ for ‘‘the lesser of—
‘‘(i) the annual deductible under such coverage, or
‘‘(ii) $4,500.’’
Subsec. (b)(4)(C). Pub. L. 109–432, § 307(b), added sub-
par. (C).
Subsec. (b)(8). Pub. L. 109–432, § 305(a), added par. (8).
Subsec. (c)(1)(B)(iii). Pub. L. 109–432, § 302(b), added cl.
(iii).
Subsec. (d)(1)(A)(ii)(I). Pub. L. 109–432, § 303(b), sub-
stituted
‘‘subsection
(b)(2)(B)’’
for
‘‘subsection
(b)(2)(B)(ii)’’.
Subsec. (g)(1). Pub. L. 109–432, § 304, inserted con-
cluding provisions.
2005—Subsec. (d)(2)(A). Pub. L. 109–135 inserted
‘‘, determined without regard to subsections (b)(1),
(b)(2), and (d)(1)(B) thereof’’ after ‘‘section 152’’.
Statutory Notes and Related Subsidiaries
EFFECTIVE DATE OF 2022 AMENDMENT
Pub. L. 117–328, div. FF, title IV, § 4151(c), Dec. 29,
2022, 136 Stat. 5931, provided that: ‘‘The amendments
made by this section [amending this section] shall
apply to plan years beginning after December 31, 2022.’’
Pub. L. 117–169, title I, § 11408(b), Aug. 16, 2022, 136
Stat. 1905, provided that: ‘‘The amendment made by
this section [amending this section] shall apply to plan
years beginning after December 31, 2022.’’
Pub. L. 117–103, div. P, title II, § 307(c), Mar. 15, 2022,
136 Stat. 807, provided that: ‘‘The amendments made by
this section [amending this section] shall take effect on
the date of the enactment of this Act [Mar. 15, 2022].’’
EFFECTIVE DATE OF 2020 AMENDMENT
Pub. L. 116–260, div. BB, title I, § 102(c)(4)(B), Dec. 27,
2020, 134 Stat. 2796, provided that: ‘‘The amendments
made by subparagraph (A) [amending this section] shall
apply for plan years beginning on or after January 1,
2022.’’
Pub. L. 116–136, div. A, title III, § 3701(c), Mar. 27, 2020,
134 Stat. 415, provided that: ‘‘The amendments made by
this section [amending this section] shall take effect on
the date of the enactment of this Act [Mar. 27, 2020].’’
Amendment by section 3702(a) of Pub. L. 116–136 ap-
plicable to amounts paid after Dec. 31, 2019, see section
3702(d)(1) of Pub. L. 116–136, set out as a note under sec-
tion 220 of this title.
EFFECTIVE DATE OF 2017 AMENDMENT
Amendment by section 11002(d)(1)(V) of Pub. L. 115–97
applicable to taxable years beginning after Dec. 31,
2017, see section 11002(e) of Pub. L. 115–97, set out as a
note under section 1 of this title.
Amendment by section 11051(b)(3)(E) of Pub. L. 115–97
applicable to any divorce or separation instrument (as
defined in former section 71(b)(2) of this title as in ef-
fect before Dec. 22, 2017) executed after Dec. 31, 2018,
and to such instruments executed on or before Dec. 31,
2018, and modified after Dec. 31, 2018, if the modifica-
tion expressly provides that the amendment made by
section 11051 of Pub. L. 115–97 applies to such modifica-
tion, see section 11051(c) of Pub. L. 115–97, set out as a
note under section 61 of this title.
EFFECTIVE DATE OF 2015 AMENDMENT
Pub. L. 114–41, title IV, § 4007(b)(2), July 31, 2015, 129
Stat. 466, provided that: ‘‘The amendment made by this
subsection [amending this section] shall apply to
months beginning after December 31, 2015.’’
EFFECTIVE DATE OF 2010 AMENDMENT
Amendment by section 9003(a) of Pub. L. 111–148 ap-
plicable to amounts paid with respect to taxable years
beginning after Dec. 31, 2010, see section 9003(d)(1) of
Pub. L. 111–148, set out as a note under section 220 of
this title.
Amendment by section 9004(a) of Pub. L. 111–148 ap-
plicable to distributions made after Dec. 31, 2010, see
section 9004(c) of Pub. L. 111–148, set out as a note under
section 220 of this title.
EFFECTIVE DATE OF 2006 AMENDMENT
Pub. L. 109–432, div. A, title III, § 302(c)(2), Dec. 20,
2006, 120 Stat. 2949, provided that: ‘‘The amendment
made by subsection (b) [amending this section] shall
take effect on the date of the enactment of this Act
[Dec. 20, 2006].’’
Pub. L. 109–432, div. A, title III, § 303(c), Dec. 20, 2006,
120 Stat. 2950, provided that: ‘‘The amendments made
by this section [amending this section] shall apply to
taxable years beginning after December 31, 2006.’’
Pub. L. 109–432, div. A, title III, § 305(b), Dec. 20, 2006,
120 Stat. 2951, provided that: ‘‘The amendments made
by this section [amending this section] shall apply to
taxable years beginning after December 31, 2006.’’
Page 976
TITLE 26—INTERNAL REVENUE CODE
§ 224
1 So in original. Does not conform to section catchline.
Pub. L. 109–432, div. A, title III, § 307(c), Dec. 20, 2006,
120 Stat. 2953, provided that: ‘‘The amendments made
by this section [amending this section and section 408
of this title] shall apply to taxable years beginning
after December 31, 2006.’’
EFFECTIVE DATE OF 2005 AMENDMENT
Amendment by Pub. L. 109–135 effective as if included
in the provisions of the Working Families Tax Relief
Act of 2004, Pub. L. 108–311, to which such amendment
relates, see section 404(d) of Pub. L. 109–135, set out as
a note under section 21 of this title.
EFFECTIVE DATE
Section applicable to taxable years beginning after
Dec. 31, 2003, see section 1201(k) of Pub. L. 108–173, set
out as an Effective Date of 2003 Amendment note under
section 62 of this title.
INFLATION ADJUSTED ITEMS FOR CERTAIN YEARS
Provisions relating to inflation adjustment of items
in this section for certain years were contained in the
following:
2023—Revenue Procedure 2022–24.
2022—Revenue Procedure 2021–25.
2021—Revenue Procedure 2020–32.
2020—Revenue Procedure 2019–25.
2019—Revenue Procedure 2018–30.
2018—Revenue Procedure 2017–37.
2017—Revenue Procedure 2016–28.
2016—Revenue Procedure 2015–30.
2015—Revenue Procedure 2014–30.
2014—Revenue Procedure 2013–25.
2013—Revenue Procedure 2012–26.
2012—Revenue Procedure 2011–32.
2011—Revenue Procedure 2010–22.
2010—Revenue Procedure 2009–29.
2009—Revenue Procedure 2008–29.
2008—Revenue Procedure 2007–36.
§ 224. Cross reference
For deductions in respect of a decedent, see sec-
tion 691.
(Aug. 16, 1954, ch. 736, 68A Stat. 72, § 217; renum-
bered § 218, Pub. L. 88–272, title II, § 213(a)(1), Feb.
26, 1964, 78 Stat. 50; renumbered § 219, Pub. L.
92–178, title VII, § 702(a), Dec. 10, 1971, 85 Stat.
561; renumbered § 220, Pub. L. 93–406, title II,
§ 2002(a)(1), Sept. 2, 1974, 88 Stat. 958; renumbered
§ 221, Pub. L. 94–455, title XV, § 1501(a), Oct. 4,
1976, 90 Stat. 1734; renumbered § 222, renumbered
§ 223, Pub. L. 97–34, title I, §§ 103(a), 125(a), Aug.
13, 1981, 95 Stat. 187, 201; renumbered § 220 and
amended Pub. L. 99–514, title I, § 135(b)(1), title
III, § 301(b)(5)(A), Oct. 22, 1986, 100 Stat. 2116, 2217;
renumbered § 221, Pub. L. 100–647, title VI,
§ 6007(a), Nov. 10, 1988, 102 Stat. 3687; renumbered
§ 220, Pub. L. 101–508, title XI, § 11802(e)(2), Nov. 5,
1990, 104 Stat. 1388–530; renumbered § 221, Pub. L.
104–191, title III, § 301(a), Aug. 21, 1996, 110 Stat.
2037; renumbered § 222, Pub. L. 105–34, title II,
§ 202(a), Aug. 5, 1997, 111 Stat. 806; renumbered
§ 223, Pub. L. 107–16, title IV, § 431(a), June 7, 2001,
115 Stat. 66; renumbered § 224, Pub. L. 108–173,
title XII, § 1201(a), Dec. 8, 2003, 117 Stat. 2469.)
Editorial Notes
AMENDMENTS
2003—Pub. L. 108–173 renumbered section 223 of this
title as this section.
2001—Pub. L. 107–16 renumbered section 222 of this
title as this section.
1997—Pub. L. 105–34 renumbered section 221 of this
title as this section.
1996—Pub. L. 104–191 renumbered section 220 of this
title as this section.
1990—Pub. L. 101–508 renumbered section 221 of this
title as this section.
1986—Pub. L. 99–514, § 135(b)(1), renumbered section 223
of this title as this section.
Pub. L. 99–514, § 301(b)(5)(A), amended section gen-
erally, substituting ‘‘reference’’ for ‘‘references’’ in sec-
tion catchline, striking out par. (1) which referred to
section 1202 for deduction for long-term capital gains in
the case of a taxpayer other than a corporation, and
striking out par. (2) designation.
1981—Pub. L. 97–34 successively renumbered sections
221 and 222 of this title as this section.
1976—Pub. L. 94–455 renumbered section 220 of this
title as this section.
1974—Pub. L. 93–406 renumbered section 219 of this
title as this section.
1971—Pub. L. 92–178 renumbered section 218 of this
title as this section.
1964—Pub. L. 88–272 renumbered section 217 of this
title as this section.
Statutory Notes and Related Subsidiaries
EFFECTIVE DATE OF 2003 AMENDMENT
Amendment by Pub. L. 108–173 applicable to taxable
years beginning after Dec. 31, 2003, see section 1201(k) of
Pub. L. 108–173, set out as a note under section 62 of
this title.
EFFECTIVE DATE OF 2001 AMENDMENT
Amendment by Pub. L. 107–16 applicable to payments
made in taxable years beginning after Dec. 31, 2001, see
section 431(d) of Pub. L. 107–16, set out as a note under
section 62 of this title.
EFFECTIVE DATE OF 1986 AMENDMENT
Amendment by section 301(b)(5)(A) of Pub. L. 99–514
applicable to taxable years beginning after Dec. 31,
1986, see section 301(c) of Pub. L. 99–514, set out as a
note under section 62 of this title.
SAVINGS PROVISION
For provisions that nothing in amendment by section
11802(e)(2) of Pub. L. 101–508 be construed to affect
treatment of certain transactions occurring, property
acquired, or items of income, loss, deduction, or credit
taken into account prior to Nov. 5, 1990, for purposes of
determining liability for tax for periods ending after
Nov. 5, 1990, see section 11821(b) of Pub. L. 101–508, set
out as a note under section 45K of this title.
PART VIII—SPECIAL DEDUCTIONS FOR
CORPORATIONS
Sec.
241.
Allowance of special deductions.
[242.
Repealed.]
243.
Dividends received by corporations.
[244.
Repealed.]
245.
Dividends received from certain foreign cor-
porations.
245A.
Deduction for foreign source-portion of divi-
dends received by domestic corporations
from certain 10-percent owned foreign cor-
porations.1
246.
Rules applying to deductions for dividends re-
ceived.
246A.
Dividends received deduction reduced where
portfolio stock is debt financed.
247.
Contributions to Alaska Native Settlement
Trusts.
248.
Organizational expenditures.
249.
Limitation on deduction of bond premium on
repurchase.
Cross-references
Connections may be documented source relationships, shared citations or nearby passages. Each explains its basis; a connection alone does not establish applicability to your situation.
Federal law — U.S. Code and appendices · legal_authorities
**(a) Deduction allowed** In the case of an individual who is an eligible individual for any month during the taxable year, there shall be allowed as a deduction for the taxable year an amount equal to the aggregate amount paid in cash during such taxable year by or on behalf of such individual to a health savings account of such individual.
**(b) Limitations**
(1) **In general** — The amount allowable as a deduction under subsection (a) to an individual for the taxable year shall not exceed the sum of the monthly limitations for months during such taxable year that the individual is an eligible individual.
(2) **Monthly limitation** — The monthly limitation for any month is 1⁄12 of—
(A) in the case of an eligible individual who has self-only coverage under a high deductible health plan as of the first day of such month, $2,250.
(B) in the case of an eligible individual who has family coverage under a high deductible health plan as of the first day of such month, $4,500.
(3) **Additional contributions for individuals 55 or older**
(A) *In general* — In the case of an individual who has attained age 55 before the close of the taxable year, the applicable limitation under subparagraphs (A) and (B) of paragraph (2) shall be increased by the additional contribution amount.
(B) *Additional contribution amount* — For purposes of this section, the additional contribution amount is the amount determined in accordance with the following table: For taxable years beginning in:The additional contribution amount is: 2004$500 2005$600 2006$700 2007$800 2008$900 2009 and thereafter$1,000.
(4) **Coordination with other contributions** — The limitation which would (but for this paragraph) apply under this subsection to an individual for any taxable year shall be reduced
Source: Supplied U.S. Code snapshot — release unconfirmed · 26 U.S.C. § 223
Stored review status: release_metadata_unconfirmed. Same stored citation; legal effect and authority still require review.
Federal law — U.S. Code and appendices · legal_authorities
**(a) Biologics license**
(1) No person shall introduce or deliver for introduction into interstate commerce any biological product unless—
(A) a biologics license under this subsection or subsection (k) is in effect for the biological product; and
(B) each package of the biological product is plainly marked with—
(i) the proper name of the biological product contained in the package;
(ii) the name, address, and applicable license number of the manufacturer of the biological product; and
(iii) the expiration date of the biological product.
(2)
(A) The Secretary shall establish, by regulation, requirements for the approval, suspension, and revocation of biologics licenses.
(B) *Pediatric studies.—* — A person that submits an application for a license under this paragraph shall submit to the Secretary as part of the application any assessments required under section 505B of the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 355c](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim)].
(C) The Secretary shall approve a biologics license application—
(i) on the basis of a demonstration that—
(I) the biological product that is the subject of the application is safe, pure, and potent; and
(II) the facility in which the biological product is manufactured, processed, packed, or held meets standards designed to assure that the biological product continues to be safe, pure, and potent; and
(ii) if the applicant (or other appropriate person) consents to the inspection of the facility that is the subject of the application, in accordance with subsection (c).
(D) *Postmarket studies and clinical trials; labeling; risk evaluation and mitigation strategy.—* — A person that sub
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 262
Stored review status: release_metadata_unconfirmed. The source passage cites 42 U.S.C. § 262. This identifies an authority to review, not proof of applicability.
Federal law — U.S. Code and appendices · legal_authorities
Page 456
TITLE 42—THE PUBLIC HEALTH AND WELFARE
§ 258a
§ 258a. Transferred
Editorial Notes
CODIFICATION
Section, act July 8, 1947, ch. 210, title II, § 201, 61 Stat.
269, which related to transfer of balances in working
capital fund, narcotic hospitals, to surplus fund, was
transferred and is set out as a note under section 290aa
of this title.
§§ 259 to 261a. Repealed. Pub. L. 106–310, div. B,
title XXXIV, § 3405(a), Oct. 17, 2000, 114 Stat.
1221, as amended by Pub. L. 114–198, title I,
§ 110(b), July 22, 2016, 130 Stat. 710
Section 259, acts July 1, 1944, ch. 373, title III, § 343, 58
Stat. 699; Pub. L. 91–513, title I, § 2(a)(2)(A), (3), (4), Oct.
27, 1970, 84 Stat. 1240; Pub. L. 92–293, § 3, May 11, 1972, 86
Stat. 136; Pub. L. 98–473, title II, § 232(b), Oct. 12, 1984, 98
Stat. 2031, related to convict addicts or other persons
with drug abuse or drug dependence problems.
Section 260, acts July 1, 1944, ch. 373, title III, § 344, 58
Stat. 701; June 25, 1948, ch. 654, § 5, 62 Stat. 1018; July 24,
1956, ch. 676, title III, § 302(b), 70 Stat. 622; Pub. L. 91–513,
title I, § 2(a)(2)(A), (3), (4), Oct. 27, 1970, 84 Stat. 1240, re-
lated to addicts and persons with drug abuse or drug
dependence problems.
Section 260a, act July 1, 1944, ch. 373, title III, § 345, as
added May 8, 1954, ch. 195, § 2, 68 Stat. 79; amended July
24, 1956, ch. 676, title III, § 302(c), 70 Stat. 622; Pub. L.
91–358, title I, § 155(c)(32), July 29, 1970, 84 Stat. 572, re-
lated to admission of addicts committed from District
of Columbia.
Section 261, acts July 1, 1944, ch. 373, title III, § 346,
formerly § 345, 58 Stat. 701; renumbered § 346, May 8,
1954, ch. 195, § 2, 68 Stat. 79; amended Pub. L. 91–513,
title I, § 2(a)(2)(A), (5), Oct. 27, 1970, 84 Stat. 1240, relate
Source: Supplied 2024 U.S. Code historical extraction · 42 U.S.C. § 262
Stored review status: historical_2024_not_currentness_verified. The source passage cites 42 U.S.C. § 262. This identifies an authority to review, not proof of applicability.