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We track 878 rules from 56 laws and lists for consumer goods here, and 2 changes starting in the next 24 months. Type your product to see which apply.

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Changes

Upcoming changes

2 changes to 2 rules start in the United States in the next 24 months. 1 more change is proposed or on hold.

Industries

Coverage

What we check here for each industry, and from when. Open an industry to see what we cover and what we don't. A law we hold but haven't checked shows as Not checked, with its quote. Anything we don't cover shows as Not covered. Neither is ever clear.

ClaraDB gives a verdict only for PFAS state laws for cookware and bakeware, California Proposition 65 consumer-product warning check for BPA, BPS, formaldehyde, styrene, antimony trioxide, vinyl acetate, lead and cadmium, California Proposition 65 warning check for candles and ceramicware (lead, cadmium, formaldehyde, acetaldehyde, benzene, naphthalene, carbon monoxide, benzo[a]pyrene), US packaging EPR producer size thresholds (California, Colorado, Maryland, Minnesota, Oregon, Washington) for a brand-owning manufacturer, US lead in children's products and furniture (lead paint and total lead content), US lead in toys and child care articles (lead paint and total lead content), US lead in children's products (other) and bags (lead paint and total lead content), US phthalates in children's toys and child care articles (DEHP, DBP, BBP, DINP, DIBP, DPENP, DHEXP, DCHP) and US children's product certificate and tracking label for children's tableware (AI-checked, quotes verified word for word). Every other answer shows the laws and quotes found without saying whether they apply. Not checked: Consumer electronics (FCC equipment authorization, 47 CFR Parts 2 and 15, energy rules). What ClaraDB has checked

Home and kitchen goodsMain sourcesfrom 1 Jan 20257 areas read · 6 not read yet

Federal regulations as published on 6 Oct 2026.

Sources read
  • TSCA section 8(a)(7) PFAS reporting and recordkeeping (40 CFR 705), shown as applying only if the product contains a PFAS
  • FDA food-contact polymers
  • coatings and paper (21 CFR 174-178)
  • decorative ceramicware labelling (21 CFR 109.16)
  • CPSC lead in paint and children's products (16 CFR 1303, 15 U.S.C. 1278a)
  • clothing storage unit tip-over (16 CFR 1261)
  • TSCA Title VI formaldehyde in composite wood (40 CFR 770)
Not read yet
  • FDA guidance on leachable lead/cadmium in ceramicware (CPG 545.450/545.500)
  • CPSC flammability standards other than those listed
  • children's product certificates and tracking labels other than for children's tableware
  • FTC labelling rules
  • upholstered furniture flammability (16 CFR 1640)
  • mattresses
Cosmetics and personal careMain sourcesfrom 1 Jan 20256 areas read · 6 not read yet
Sources read
  • TSCA section 8(a)(7) PFAS reporting and recordkeeping (40 CFR 705), shown as applying only if the product contains a PFAS
  • FD&C Act ch. VI cosmetics as amended by MoCRA (21 U.S.C. 361-364j: adulteration, misbranding, adverse events, GMP, registration and listing, safety substantiation, labelling)
  • 21 CFR 700, 701, 710, 720
  • 740 and color additive parts 73
  • OTC sunscreen: 21 CFR 201.327 labeling, SPF, broad-spectrum and water-resistance tests; 21 CFR 201.66 Drug Facts; 21 CFR part 207 establishment registration, drug listing and NDC
  • 74 and 82 where cosmetics are named
Not read yet
  • OTC drug products other than sunscreen (antiperspirant M019, anti-dandruff, fluoride toothpaste M021)
  • for sunscreen: the M020 list of permitted active ingredients and concentrations, and OMUFA facility fees
  • FPLA and 16 CFR 500 packaging rules
  • FDA GMP and talc-asbestos testing rules until final
  • color additive petition status after ClaraDB's data date
  • state law other than listed US states
Packaged food and beveragesMain sourcesfrom 7 Oct 20267 areas read · 11 not read yet

Federal food regulations as published on 7 Oct 2026.

Sources read
  • TSCA section 8(a)(7) PFAS reporting and recordkeeping (40 CFR 705), shown as applying only if the product contains a PFAS
  • 21 CFR 101 food labelling (statement of identity, net quantity, ingredient list, allergen declaration incl. sesame under FALCPA and FASTER, nutrition facts, name and place of business)
  • FD&C Act sec. 403 misbranding (21 U.S.C. 343)
  • 21 CFR 170-189 additive status where listable (172 direct additives, 173, 180, 182 GRAS substances, 184)
  • facility registration (21 CFR 1 subpart H)
  • prior notice (subpart I)
  • FSMA FSVP (21 CFR 1 subpart L)
Not read yet
  • GRAS notices outside the listed 21 CFR parts
  • standards of identity (21 CFR 130-169)
  • Part 117 preventive-control details (only who must comply and the qualified-facility rules are encoded)
  • seafood and juice HACCP
  • FPLA and 16 CFR 500
  • FDA action levels and guidance levels for contaminants (not binding limits)
  • state laws other than listed
  • USDA-regulated meat
  • poultry and egg products
  • dietary supplements
  • infant formula
Consumer electronics and small appliancesMain sourcesfrom 1 Jan 20255 areas read · 6 not read yet
Sources read
  • TSCA section 8(a)(7) PFAS reporting and recordkeeping (40 CFR 705), shown as applying only if the product contains a PFAS
  • FCC Part 15 marking, SDoC and information to the user (47 CFR 15.19, 15.21, 15.105)
  • 47 CFR part 2 subpart J equipment authorization
  • Part 18 for consumer ISM appliances where applicable
  • DOE energy conservation labels for listed consumer products (10 CFR 430 subpart C) and FTC Energy Labeling Rule (16 CFR 305)
Not read yet
  • CPSC product-specific rules for electrical goods
  • UL and NRTL listing (voluntary)
  • state e-waste laws other than California
  • FCC certification of radio modules (TCB process)
  • DOE standards for non-listed products
  • TSCA and PFAS in electronics outside the listed instruments
Batteries, e-bikes and power banksMain sourcesfrom 1 Oct 20267 areas read · 5 not read yet

Federal regulations as published on 1 Oct 2026; US Code from the 2024 edition.

Sources read
  • TSCA section 8(a)(7) PFAS reporting and recordkeeping (40 CFR 705), shown as applying only if the product contains a PFAS
  • CPSC button cell or coin battery safety standard (16 CFR 1263)
  • low-speed electric bicycles (15 U.S.C. 2085; 16 CFR 1512 and 1500.18)
  • Mercury-Containing and Rechargeable Battery Management Act (42 U.S.C. 14301 ff)
  • lithium cell carriage (49 CFR 173.185) and universal waste (40 CFR 273)
  • DOE battery charger standards sit in 10 CFR 430 subpart C (covered under consumer electronics)
  • FCC Part 15 and Part 2 subpart J for power banks and battery chargers (the electronics rules applied to these categories)
Not read yet
  • CPSC rulemaking on lithium-ion batteries in micromobility products (not stored)
  • UL 2849, 2271, 2272, 2054 and 2056 standard texts (paid, voluntary)
  • 49 CFR parts 171-180 beyond 173.185 and IATA/ICAO rules
  • state battery stewardship and labelling laws other than NYC LL39 (not stored)
  • 40 CFR 273 universal-waste duties on handlers (not a seller or manufacturer duty) and 49 CFR 173.185 shipper-side limits other than the manufacturer test record and summary are not covered

Types

Rules by type

What the rules require. Pick a type to filter the laws below; pick it again to show every type.

Laws

Rules by law

13 of 878 rules match the type registrations. Open a law to read its rules.

Type: Registrations. Show every type

21 CFR Part 207 Requirements for foreign and domestic establishment registration and listing for human drugs, including drugs that are regulated under a biologics license application, and animal drugs, and the National Drug Code21 CFR 2077 rulesIn force from: 31 Aug 2016Industries: Cosmetics
Requirement
Applies when
Effective
Source
Registration

Review and update of drug listing information each June and December

Registration required

FDA drug listing: review and update each June and December (new drugs, discontinuations, resumptions, material changes, or a no-changes certification)

Consolidated text (not the authentic legal edition), current to 1 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-01 per the eCFR.

  • Your role: Manufacturer
  • Makes a drug claim (for example sunscreen or anti-dandruff)

Depends on: economic operator role, otc drug claim

In force since 31 Aug 2016

Applies to products distributed on or after 31 Aug 2016

In force from 2016-08-31: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

“Registrants must review and update their drug listing information each June and December.”
21 CFR 207.57(b) · fetched 2026-10-11US National Archives / Office of the Federal Register (eCFR): 21 CFR 207(opens in a new tab)
Registration

Drug listing with FDA for each drug you manufacture, repack, relabel or salvage

Registration required

FDA drug listing: each registrant lists each drug it manufactures, repacks, relabels or salvages for commercial distribution, no later than 3 calendar days after initial registration of the establishment (for drugs made there at that time); a drug made for a private label distributor is listed under an NDC with that distributor's labeler code and, for human drugs, also under the registrant's own labeler code

Exemptions (1)

A foreign establishment need not register and list if its drugs enter a foreign trade zone and are re-exported without entering U.S. commerce, or are imported under FD&C Act section 801(d)(3).

“Their drugs enter a foreign trade zone and are re-exported without having entered U.S. commerce, or”
21 CFR 207.13(j) (excerpt) · fetched 2026-10-11US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 207(opens in a new tab)

Consolidated text (not the authentic legal edition), current to 1 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-01 per the eCFR.

  • Your role: Manufacturer
  • Makes a drug claim (for example sunscreen or anti-dandruff)

Depends on: economic operator role, otc drug claim

In force since 31 Aug 2016

Applies to products manufactured on or after 31 Aug 2016

In force from 2016-08-31: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

“Each registrant must list each drug that it manufactures, repacks, relabels, or salvages for commercial distribution.”
21 CFR 207.41(a); 207.45 · fetched 2026-10-11US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 207(opens in a new tab)
Registration

Annual review and update of establishment registration information

Registration required

FDA drug establishment registration: annual review and update between October 1 and December 31 of each calendar year (certify no changes if none)

Exemptions (1)

Private label distributors who do not also manufacture, repack, relabel, or salvage drugs are not required to register.

“Private label distributors who do not also manufacture, repack, relabel, or salvage drugs are not required to register under this part.”
21 CFR 207.17(b) · fetched 2026-10-11US National Archives / Office of the Federal Register (eCFR): 21 CFR 207(opens in a new tab)

Consolidated text (not the authentic legal edition), current to 1 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-01 per the eCFR.

  • Your role: Manufacturer
  • Makes a drug claim (for example sunscreen or anti-dandruff)

Depends on: economic operator role, otc drug claim

In force since 31 Aug 2016

Applies to products manufactured on or after 31 Aug 2016

In force from 2016-08-31: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

“Subsequent reviews and updates must occur annually, during the period beginning on October 1 and ending December 31 of each calendar year.”
21 CFR 207.29(b)(1) · fetched 2026-10-11US National Archives / Office of the Federal Register (eCFR): 21 CFR 207(opens in a new tab)
Registration

Register each establishment that manufactures, repacks or relabels the drug with FDA

Registration required

FDA drug establishment registration (electronic drug registration and listing system): each domestic establishment that manufactures, repacks, relabels or salvages the drug, no later than 5 calendar days after beginning those operations there

Exemptions (1)

Private label distributors who do not also manufacture, repack, relabel or salvage drugs are not required to register.

“Private label distributors who do not also manufacture, repack, relabel, or salvage drugs are not required to register under this part.”
21 CFR 207.17(b) · fetched 2026-10-11US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 207(opens in a new tab)

Consolidated text (not the authentic legal edition), current to 1 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-01 per the eCFR.

  • Your role: Manufacturer
  • Makes a drug claim (for example sunscreen or anti-dandruff)

Depends on: economic operator role, otc drug claim

In force since 31 Aug 2016

Applies to products manufactured on or after 31 Aug 2016

In force from 2016-08-31: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

“Registrants must register each domestic establishment no later than 5 calendar days after beginning to manufacture, repack, relabel, or salvage a drug”
21 CFR 207.17(a); 207.21(a) (excerpt) · fetched 2026-10-11US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 207(opens in a new tab)
Registration

NDC labeler code from FDA

Registration required

FDA NDC labeler code: each person who manufactures, repacks, relabels or is the private label distributor of a drug subject to listing applies for a labeler code (electronically) and updates the information within 30 calendar days of any change

Consolidated text (not the authentic legal edition), current to 1 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-01 per the eCFR.

  • Your role: Manufacturer
  • Makes a drug claim (for example sunscreen or anti-dandruff)

Depends on: economic operator role, otc drug claim

In force since 31 Aug 2016

Applies to products manufactured on or after 31 Aug 2016

In force from 2016-08-31: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

“Each person who engages in manufacturing, repacking, relabeling, or private label distribution of a drug subject to listing under this part must apply for an NDC labeler code”
21 CFR 207.33(c)(1) (excerpt) · fetched 2026-10-11US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 207(opens in a new tab)
Registration

Foreign drug establishment registration

Registration required

FDA drug establishment registration (electronic drug registration and listing system): each foreign establishment that manufactures, repacks, relabels or salvages the drug, before the drug is imported or offered for import into the United States

Exemptions (2)

Private label distributors who do not also manufacture, repack, relabel or salvage drugs are not required to register.

“Private label distributors who do not also manufacture, repack, relabel, or salvage drugs are not required to register under this part.”
21 CFR 207.17(b) · fetched 2026-10-11US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 207(opens in a new tab)

A foreign establishment need not register and list if its drugs enter a foreign trade zone and are re-exported without entering U.S. commerce, or are imported under FD&C Act section 801(d)(3).

“Their drugs enter a foreign trade zone and are re-exported without having entered U.S. commerce, or”
21 CFR 207.13(j) (excerpt) · fetched 2026-10-11US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 207(opens in a new tab)

Consolidated text (not the authentic legal edition), current to 1 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-01 per the eCFR.

  • Your role: Manufacturer
  • Imported into the market of sale
  • Makes a drug claim (for example sunscreen or anti-dandruff)

Depends on: economic operator role, imported, otc drug claim

In force since 31 Aug 2016

Applies to products imported on or after 31 Aug 2016

In force from 2016-08-31: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

“Registrants must register each foreign establishment before a drug or an animal feed bearing or containing a new animal drug manufactured, repacked, relabeled, or salvaged at the establishment is imported or offered for import into the United States.”
21 CFR 207.17(a); 207.21(b) · fetched 2026-10-11US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 207(opens in a new tab)
Registration

Unique National Drug Code (NDC) for each listed finished drug product

Registration required

National Drug Code (NDC): unique 10- or 11-digit code identifying labeler, product, and package size and type, proposed with the listing and assigned by FDA

Consolidated text (not the authentic legal edition), current to 1 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-01 per the eCFR.

  • Makes a drug claim (for example sunscreen or anti-dandruff)

Depends on: otc drug claim

In force since 31 Aug 2016

Applies to products distributed on or after 31 Aug 2016

In force from 2016-08-31: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

“Each finished drug product or unfinished drug subject to the listing requirements of this part must have a unique NDC to identify its labeler, product, and package size and type.”
21 CFR 207.33(a) · fetched 2026-10-11US National Archives / Office of the Federal Register (eCFR): 21 CFR 207(opens in a new tab)
  • Registration

    Review and update of drug listing information each June and December

    Registration required

    FDA drug listing: review and update each June and December (new drugs, discontinuations, resumptions, material changes, or a no-changes certification)

    Consolidated text (not the authentic legal edition), current to 1 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-01 per the eCFR.

    Applies when
    • Your role: Manufacturer
    • Makes a drug claim (for example sunscreen or anti-dandruff)

    Depends on: economic operator role, otc drug claim

    Effective

    In force since 31 Aug 2016

    Applies to products distributed on or after 31 Aug 2016

    In force from 2016-08-31: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

    Source
    “Registrants must review and update their drug listing information each June and December.”
    21 CFR 207.57(b) · fetched 2026-10-11US National Archives / Office of the Federal Register (eCFR): 21 CFR 207(opens in a new tab)
  • Registration

    Drug listing with FDA for each drug you manufacture, repack, relabel or salvage

    Registration required

    FDA drug listing: each registrant lists each drug it manufactures, repacks, relabels or salvages for commercial distribution, no later than 3 calendar days after initial registration of the establishment (for drugs made there at that time); a drug made for a private label distributor is listed under an NDC with that distributor's labeler code and, for human drugs, also under the registrant's own labeler code

    Exemptions (1)

    A foreign establishment need not register and list if its drugs enter a foreign trade zone and are re-exported without entering U.S. commerce, or are imported under FD&C Act section 801(d)(3).

    “Their drugs enter a foreign trade zone and are re-exported without having entered U.S. commerce, or”
    21 CFR 207.13(j) (excerpt) · fetched 2026-10-11US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 207(opens in a new tab)

    Consolidated text (not the authentic legal edition), current to 1 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-01 per the eCFR.

    Applies when
    • Your role: Manufacturer
    • Makes a drug claim (for example sunscreen or anti-dandruff)

    Depends on: economic operator role, otc drug claim

    Effective

    In force since 31 Aug 2016

    Applies to products manufactured on or after 31 Aug 2016

    In force from 2016-08-31: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

    Source
    “Each registrant must list each drug that it manufactures, repacks, relabels, or salvages for commercial distribution.”
    21 CFR 207.41(a); 207.45 · fetched 2026-10-11US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 207(opens in a new tab)
  • Registration

    Annual review and update of establishment registration information

    Registration required

    FDA drug establishment registration: annual review and update between October 1 and December 31 of each calendar year (certify no changes if none)

    Exemptions (1)

    Private label distributors who do not also manufacture, repack, relabel, or salvage drugs are not required to register.

    “Private label distributors who do not also manufacture, repack, relabel, or salvage drugs are not required to register under this part.”
    21 CFR 207.17(b) · fetched 2026-10-11US National Archives / Office of the Federal Register (eCFR): 21 CFR 207(opens in a new tab)

    Consolidated text (not the authentic legal edition), current to 1 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-01 per the eCFR.

    Applies when
    • Your role: Manufacturer
    • Makes a drug claim (for example sunscreen or anti-dandruff)

    Depends on: economic operator role, otc drug claim

    Effective

    In force since 31 Aug 2016

    Applies to products manufactured on or after 31 Aug 2016

    In force from 2016-08-31: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

    Source
    “Subsequent reviews and updates must occur annually, during the period beginning on October 1 and ending December 31 of each calendar year.”
    21 CFR 207.29(b)(1) · fetched 2026-10-11US National Archives / Office of the Federal Register (eCFR): 21 CFR 207(opens in a new tab)
  • Registration

    Register each establishment that manufactures, repacks or relabels the drug with FDA

    Registration required

    FDA drug establishment registration (electronic drug registration and listing system): each domestic establishment that manufactures, repacks, relabels or salvages the drug, no later than 5 calendar days after beginning those operations there

    Exemptions (1)

    Private label distributors who do not also manufacture, repack, relabel or salvage drugs are not required to register.

    “Private label distributors who do not also manufacture, repack, relabel, or salvage drugs are not required to register under this part.”
    21 CFR 207.17(b) · fetched 2026-10-11US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 207(opens in a new tab)

    Consolidated text (not the authentic legal edition), current to 1 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-01 per the eCFR.

    Applies when
    • Your role: Manufacturer
    • Makes a drug claim (for example sunscreen or anti-dandruff)

    Depends on: economic operator role, otc drug claim

    Effective

    In force since 31 Aug 2016

    Applies to products manufactured on or after 31 Aug 2016

    In force from 2016-08-31: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

    Source
    “Registrants must register each domestic establishment no later than 5 calendar days after beginning to manufacture, repack, relabel, or salvage a drug”
    21 CFR 207.17(a); 207.21(a) (excerpt) · fetched 2026-10-11US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 207(opens in a new tab)
  • Registration

    NDC labeler code from FDA

    Registration required

    FDA NDC labeler code: each person who manufactures, repacks, relabels or is the private label distributor of a drug subject to listing applies for a labeler code (electronically) and updates the information within 30 calendar days of any change

    Consolidated text (not the authentic legal edition), current to 1 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-01 per the eCFR.

    Applies when
    • Your role: Manufacturer
    • Makes a drug claim (for example sunscreen or anti-dandruff)

    Depends on: economic operator role, otc drug claim

    Effective

    In force since 31 Aug 2016

    Applies to products manufactured on or after 31 Aug 2016

    In force from 2016-08-31: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

    Source
    “Each person who engages in manufacturing, repacking, relabeling, or private label distribution of a drug subject to listing under this part must apply for an NDC labeler code”
    21 CFR 207.33(c)(1) (excerpt) · fetched 2026-10-11US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 207(opens in a new tab)
  • Registration

    Foreign drug establishment registration

    Registration required

    FDA drug establishment registration (electronic drug registration and listing system): each foreign establishment that manufactures, repacks, relabels or salvages the drug, before the drug is imported or offered for import into the United States

    Exemptions (2)

    Private label distributors who do not also manufacture, repack, relabel or salvage drugs are not required to register.

    “Private label distributors who do not also manufacture, repack, relabel, or salvage drugs are not required to register under this part.”
    21 CFR 207.17(b) · fetched 2026-10-11US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 207(opens in a new tab)

    A foreign establishment need not register and list if its drugs enter a foreign trade zone and are re-exported without entering U.S. commerce, or are imported under FD&C Act section 801(d)(3).

    “Their drugs enter a foreign trade zone and are re-exported without having entered U.S. commerce, or”
    21 CFR 207.13(j) (excerpt) · fetched 2026-10-11US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 207(opens in a new tab)

    Consolidated text (not the authentic legal edition), current to 1 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-01 per the eCFR.

    Applies when
    • Your role: Manufacturer
    • Imported into the market of sale
    • Makes a drug claim (for example sunscreen or anti-dandruff)

    Depends on: economic operator role, imported, otc drug claim

    Effective

    In force since 31 Aug 2016

    Applies to products imported on or after 31 Aug 2016

    In force from 2016-08-31: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

    Source
    “Registrants must register each foreign establishment before a drug or an animal feed bearing or containing a new animal drug manufactured, repacked, relabeled, or salvaged at the establishment is imported or offered for import into the United States.”
    21 CFR 207.17(a); 207.21(b) · fetched 2026-10-11US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 207(opens in a new tab)
  • Registration

    Unique National Drug Code (NDC) for each listed finished drug product

    Registration required

    National Drug Code (NDC): unique 10- or 11-digit code identifying labeler, product, and package size and type, proposed with the listing and assigned by FDA

    Consolidated text (not the authentic legal edition), current to 1 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-01 per the eCFR.

    Applies when
    • Makes a drug claim (for example sunscreen or anti-dandruff)

    Depends on: otc drug claim

    Effective

    In force since 31 Aug 2016

    Applies to products distributed on or after 31 Aug 2016

    In force from 2016-08-31: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

    Source
    “Each finished drug product or unfinished drug subject to the listing requirements of this part must have a unique NDC to identify its labeler, product, and package size and type.”
    21 CFR 207.33(a) · fetched 2026-10-11US National Archives / Office of the Federal Register (eCFR): 21 CFR 207(opens in a new tab)

Categories

Categories with rules

The product categories with the most rules here, sub-categories included.

Sources

Sources

Where the rules come from, and when we last checked each source.

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