21 CFR 7.42 - Recall strategy.

§ 7.42 Recall strategy.
(a) General.
(1) A recall strategy that takes into account the following factors will be developed by the agency for a Food and Drug Administration-requested recall and by the recalling firm for a firm-initiated recall to suit the individual circumstances of the particular recall:
(i) Results of health hazard evaluation.
(ii) Ease in identifying the product.
(iii) Degree to which the product's deficiency is obvious to the consumer or user.
(iv) Degree to which the product remains unused in the market-place.
(v) Continued availability of essential products.
(2) The Food and Drug Administration will review the adequacy of a proposed recall strategy developed by a recalling firm and recommend changes as appropriate. A recalling firm should conduct the recall in accordance with an approved recall strategy but need not delay initiation of a recall pending review of its recall strategy.
(b) Elements of a recall strategy. A recall strategy will address the following elements regarding the conduct of the recall:
(1) Depth of recall. Depending on the product's degree of hazard and extent of distribution, the recall strategy will specify the level in the distribution chain to which the recall is to extend, as follows:
(i) Consumer or user level, which may vary with product, including any intermediate wholesale or retail level; or
(ii) Retail level, including any intermediate wholesale level; or
(iii) Wholesale level.
(2) Public warning. The purpose of a public warning is to alert the public that a product being recalled presents a serious hazard to health. It is reserved for urgent situations where other means for preventing use of the recalled product appear inadequate. The Food and Drug Administration in consultation with the recalling firm will ordinarily issue such publicity. The recalling firm that decides to issue its own public warning is requested to submit its proposed public warning and plan for distribution of the warning for review and comment by the Food and Drug Administration. The recall strategy will specify whether a public warning is needed and whether it will issue as:
(i) General public warning through the general news media, either national or local as appropriate, or
(ii) Public warning through specialized news media, e.g., professional or trade press, or to specific segments of the population such as physicians, hospitals, etc.
(3) Effectiveness checks. The purpose of effectiveness checks is to verify that all consignees at the recall depth specified by the strategy have received notification about the recall and have taken appropriate action. The method for contacting consignees may be accomplished by personal visits, telephone calls, letters, or a combination thereof. A guide entitled “Methods for Conducting Recall Effectiveness Checks” that describes the use of these different methods is available upon request from the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. The recalling firm will ordinarily be responsible for conducting effectiveness checks, but the Food and Drug Administration will assist in this task where necessary and appropriate. The recall strategy will specify the method(s) to be used for and the level of effectiveness checks that will be conducted, as follows:
(i) Level A—100 percent of the total number of consignees to be contacted;
(ii) Level B—Some percentage of the total number of consignees to be contacted, which percentage is to be determined on a case-by-case basis, but is greater that 10 percent and less than 100 percent of the total number of consignees;
(iii) Level C—10 percent of the total number of consignees to be contacted;
(iv) Level D—2 percent of the total number of consignees to be contacted; or
(v) Level E—No effectiveness checks.
[43 FR 26218, June 16, 1978, as amended at 46 FR 8455, Jan. 27, 1981; 59 FR 14363, Mar. 28, 1994; 68 FR 24879, May 9, 2003]

Title 21 published on 2013-04-01

no entries appear in the Federal Register after this date.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code
U.S. Code: Title 21 - FOOD AND DRUGS

§ 321 - Definitions; generally

§ 321a - “Butter” defined

§ 321b - “Package” defined

§ 321c - Nonfat dry milk; “milk” defined

§ 321d - Market names for catfish and ginseng

§ 331 - Prohibited acts

§ 332 - Injunction proceedings

§ 333 - Penalties

§ 333a - Repealed.

§ 334 - Seizure

§ 335 - Hearing before report of criminal violation

§ 335a - Debarment, temporary denial of approval, and suspension

§ 335b - Civil penalties

§ 335c - Authority to withdraw approval of abbreviated drug applications

§ 336 - Report of minor violations

§ 337 - Proceedings in name of United States; provision as to subpoenas

§ 341 - Definitions and standards for food

§ 342 - Adulterated food

§ 343 - Misbranded food

21 U.S. Code § 343–1 - National uniform nutrition labeling

21 U.S. Code § 343–2 - Dietary supplement labeling exemptions

21 U.S. Code § 343–3 - Disclosure

§ 343a - Repealed.

§ 344 - Emergency permit control

§ 345 - Regulations making exemptions

§ 346 - Tolerances for poisonous or deleterious substances in food; regulations

§ 346a - Tolerances and exemptions for pesticide chemical residues

§ 346b - Authorization of appropriations

§ 347 - Intrastate sales of colored oleomargarine

§ 347a - Congressional declaration of policy regarding oleomargarine sales

§ 347b - Contravention of State laws

§ 348 - Food additives

§ 349 - Bottled drinking water standards; publication in Federal Register

§ 350 - Vitamins and minerals

§ 350a - Infant formulas

§ 350b - New dietary ingredients

§ 350c - Maintenance and inspection of records

§ 350d - Registration of food facilities

§ 350e - Sanitary transportation practices

§ 350f - Reportable food registry

§ 350g - Hazard analysis and risk-based preventive controls

§ 350h - Standards for produce safety

§ 350i - Protection against intentional adulteration

§ 350j - Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report

§ 350k - Laboratory accreditation for analyses of foods

21 U.S. Code § -

21 U.S. Code § -

§ 351 - Adulterated drugs and devices

§ 352 - Misbranded drugs and devices

§ 353 - Exemptions and consideration for certain drugs, devices, and biological products

§ 353a - Pharmacy compounding

§ 353b - Outsourcing facilities

§ 354 - Veterinary feed directive drugs

§ 355 - New drugs

21 U.S. Code § 355–1 - Risk evaluation and mitigation strategies

§ 355a - Pediatric studies of drugs

§ 355b - Adverse-event reporting

§ 355c - Research into pediatric uses for drugs and biological products

§ 355d - Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers

§ 355e - Pharmaceutical security

§ 356 - Expedited approval of drugs for serious or life-threatening diseases or conditions

21 U.S. Code § 356–1 - Accelerated approval of priority countermeasures

§ 356a - Manufacturing changes

§ 356b - Reports of postmarketing studies

§ 356c - Discontinuance or interruption in the production of life-saving drugs

§ 357 - Repealed.

§ 358 - Authority to designate official names

§ 359 - Nonapplicability of subchapter to cosmetics

§ 360 - Registration of producers of drugs or devices

§ 360a - Clinical trial guidance for antibiotic drugs

§ 360b - New animal drugs

§ 360c - Classification of devices intended for human use

§ 360d - Performance standards

§ 360e - Premarket approval

21 U.S. Code § 360e–1 - Pediatric uses of devices

§ 360f - Banned devices

§ 360g - Judicial review

§ 360h - Notification and other remedies

§ 360i - Records and reports on devices

§ 360j - General provisions respecting control of devices intended for human use

§ 360k - State and local requirements respecting devices

21 U.S. Code § -

§ 360m - Accredited persons

§ 360n - Priority review to encourage treatments for tropical diseases

§ 360aa - Recommendations for investigations of drugs for rare diseases or conditions

§ 360bb - Designation of drugs for rare diseases or conditions

§ 360cc - Protection for drugs for rare diseases or conditions

§ 360dd - Open protocols for investigations of drugs for rare diseases or conditions

§ 360ee - Grants and contracts for development of drugs for rare diseases and conditions

§ 360hh - Definitions

§ 360ii - Program of control

§ 360jj - Studies by Secretary

§ 360kk - Performance standards for electronic products

21 U.S. Code § -

§ 360mm - Imports

§ 360nn - Inspection, records, and reports

21 U.S. Code § -

§ 360pp - Enforcement

§ 360qq - Repealed.

§ 360rr - Federal-State cooperation

§ 360ss - State standards

§ 360aaa to 360aaa–6 - Omitted

§ 360bbb - Expanded access to unapproved therapies and diagnostics

21 U.S. Code § 360bbb–1 - Dispute resolution

21 U.S. Code § 360bbb–2 - Classification of products

21 U.S. Code § 360bbb–3 - Authorization for medical products for use in emergencies

21 U.S. Code § 360bbb–4 - Countermeasure development, review, and technical assistance

21 U.S. Code § 360bbb–5 - Critical Path Public-Private Partnerships

21 U.S. Code § 360bbb–6 - Risk communication

§ 360ccc - Conditional approval of new animal drugs for minor use and minor species

21 U.S. Code § 360ccc–1 - Index of legally marketed unapproved new animal drugs for minor species

21 U.S. Code § 360ccc–2 - Designated new animal drugs for minor use or minor species

§ 361 - Adulterated cosmetics

§ 362 - Misbranded cosmetics

§ 363 - Regulations making exemptions

§ 364 - Repealed.

§ 371 - Regulations and hearings

§ 372 - Examinations and investigations

§ 372a - Transferred

§ 373 - Records

§ 374 - Inspection

§ 374a - Inspections relating to food allergens

§ 375 - Publicity

§ 376 - Examination of sea food on request of packer; marking food with results; fees; penalties

§ 377 - Revision of United States Pharmacopoeia; development of analysis and mechanical and physical tests

§ 378 - Advertising of foods

§ 379 - Confidential information

§ 379a - Presumption of existence of jurisdiction

§ 379b - Consolidated administrative and laboratory facility

§ 379c - Transferred

§ 379d - Automation of Food and Drug Administration

21 U.S. Code § 379d–1 - Conflicts of interest

21 U.S. Code § 379d–2 - Policy on the review and clearance of scientific articles published by FDA employees

§ 379e - Listing and certification of color additives for foods, drugs, devices, and cosmetics

§ 379f - Recovery and retention of fees for freedom of information requests

§ 379g - Definitions

§ 379h - Authority to assess and use drug fees

21 U.S. Code § 379h–1 - Fees relating to advisory review of prescription-drug television advertising

21 U.S. Code § 379h–2 - Reauthorization; reporting requirements

§ 379i - Definitions

§ 379j - Authority to assess and use device fees

21 U.S. Code § 379j–1 - Reauthorization; reporting requirements

21 U.S. Code § 379j–11 - Definitions

21 U.S. Code § 379j–12 - Authority to assess and use animal drug fees

21 U.S. Code § 379j–13 - Reauthorization; reporting requirements

21 U.S. Code § 379j–21 - Authority to assess and use generic new animal drug fees

21 U.S. Code § 379j–22 - Reauthorization; reporting requirements

21 U.S. Code § 379j–31 - Authority to collect and use fees

§ 379k - Information system

21 U.S. Code § -

21 U.S. Code § -

§ 379r - National uniformity for nonprescription drugs

§ 379s - Preemption for labeling or packaging of cosmetics

§ 379v - Safety report disclaimers

§ 379aa - Serious adverse event reporting for nonprescription drugs

21 U.S. Code § 379aa–1 - Serious adverse event reporting for dietary supplements

§ 379dd - Establishment and functions of the Foundation

21 U.S. Code § 379dd–1 - Location of Foundation

21 U.S. Code § 379dd–2 - Activities of the Food and Drug Administration

§ 381 - Imports and exports

§ 382 - Exports of certain unapproved products

§ 383 - Office of International Relations

§ 384 - Importation of prescription drugs

§ 384a - Foreign supplier verification program

§ 384b - Voluntary qualified importer program

§ 384c - Inspection of foreign food facilities

§ 384d - Accreditation of third-party auditors

§ 387 - Definitions

§ 387a - FDA authority over tobacco products

21 U.S. Code § 387a–1 - Final rule

§ 387b - Adulterated tobacco products

§ 387c - Misbranded tobacco products

§ 387d - Submission of health information to the Secretary

§ 387e - Annual registration

§ 387f - General provisions respecting control of tobacco products

21 U.S. Code § 387f–1 - Enforcement action plan for advertising and promotion restrictions

§ 387g - Tobacco product standards

§ 387h - Notification and other remedies

§ 387i - Records and reports on tobacco products

§ 387j - Application for review of certain tobacco products

§ 387k - Modified risk tobacco products

21 U.S. Code § -

§ 387m - Equal treatment of retail outlets

§ 387n - Jurisdiction of and coordination with the Federal Trade Commission

21 U.S. Code § -

§ 387p - Preservation of State and local authority

§ 387q - Tobacco Products Scientific Advisory Committee

§ 387r - Drug products used to treat tobacco dependence

§ 387s - User fees

§ 387t - Labeling, recordkeeping, records inspection

§ 387u - Studies of progress and effectiveness

§ 391 - Separability clause

§ 392 - Exemption of meats and meat food products

§ 393 - Food and Drug Administration

U.S. Code: Title 42 - THE PUBLIC HEALTH AND WELFARE