Preambles are the notes that FDA publishes when it announces a proposed or final rule. They respond to comments submitted by industry and the public, and often reveal the intent and FDA's interpretation of the regulation. All preamble files are in PDF format, and require Adobe Acrobat Reader to view.
- 20 March 2012 (77 FR 16163)
The Food and Drug Administration (FDA) is amending the packaging and labeling control provisions of the current good manufacturing practice (CGMP) regulations for human and veterinary drug products by limiting the application of special control procedures for the use of cut labeling to immediate container labels, individual unit cartons, or multiunit cartons containing immediate containers that are not packaged in individual unit cartons. FDA is also permitting the use of any automated technique, including differentiation by labeling size and shape, that physically prevents incorrect labeling from being processed by labeling and packaging equipment when cut labeling is used. This action is intended to protect consumers from labeling errors more likely to cause adverse health consequences, while eliminating the regulatory burden of applying the rule to labeling unlikely to reach or adversely affect consumers. This action is also intended to permit manufacturers to use a broader range of error prevention and labeling control techniques than permitted by current CGMPs.
- 10 December 2009(74 FR 65431)
FDA is issuing regulations on current good manufacturing practice (CGMP) for positron emission tomography (PET) drugs. The regulations are intended to ensure that PET drugs meet the requirements of the Federal Food, Drug, and Cosmetic Act (the act) regarding safety, identity, strength, quality, and purity. In this final rule, we are establishing CGMP regulations for approved PET drugs. For investigation and research PET drugs, the final rule states that the requirement to follow CGMP may be met by complying with these regulations or by producing PET drugs in accordance with the United States Pharmacopeia (USP) general
chapter on compounding PET radio pharmaceuticals. We are establishing these CGMP requirements for PET drugs under the provisions of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act).
- 8 September 2008 (73 FR 51933)
The Food and Drug Administration (FDA) is amending certain of its regulations on current good manufacturing practice (CGMP) requirements for finished pharmaceuticals as the culmination of the first phase of an incremental approach to modifying the CGMP regulations for these products. This rule revises CGMP requirements primarily concerning aseptic processing, verification of performance of operations by a second individual, and the use of asbestos filters. We are amending the regulations to modernize or clarify some of the requirements as well as to harmonize them with other FDA regulations and international CGMP standards.
- 15 July 2008 (73 FR 40463)
FDA is amending the current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most phase 1 investigational drugs from complying with the regulatory CGMP requirements. FDA will continue to exercise oversight of the manufacture of these drugs under FDA's general statutory CGMP authority and through review of the investigational new drug applications (IND).
- 4 April 2008 (73 FR 18441)
FDA) is withdrawing a direct final rule that published in the Federal Register of December 4, 2007 (72 FR 68064), to amend certain regulations as the first phase of an incremental approach to modernize or clarify some of the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, as well as harmonize some of the CGMP requirements with those of other foreign regulators and other FDA regulations. The comment period closed February 19, 2008. FDA is withdrawing the direct final rule because the agency received significant adverse comments. FDA will consider the comments received under our usual procedures for notice and comment in connection with the notice of proposed rulemaking that was published in the Federal Register of December 4, 2007, as a companion to the direct final rule (72 FR 68113).
- 4 December 2007 (72 FR 68068)
Direct final rule amending certain regulations as the first phase of an incremental approach to modifying the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. We are amending the regulations to modernize or clarify some of the CGMP requirements, as well as harmonize some of the CGMP requirements with those of other foreign regulators and other FDA regulations. These amendments are also consistent with current industry practice.
- 4 December 2007 (72 FR 68111)
Withdrawal of a proposed rule published in the Federal Register of May 3, 1996 (61 FR 20103) .The May 1996 proposed rule would have amended certain requirements of the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. These proposed changes would have clarified certain manufacturing, quality control, and documentation requirements and would have updated the requirements for process and methods validation. In light of more recent scientific and technical advances and evolving quality systems and risk management concepts, FDA concludes that, at this time, it is appropriate to withdraw the May 1996 proposed rule and newly evaluate the issues raised in that proposal.
- 4 December 2007 (72 FR 68113)
Companion proposed rule to the direct final rule, published elsewhere in the same issue of the Federal Register, which is intended to amend certain sections of the regulations as the first phase of an incremental approach to modifying the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.
- 30 March 2007 (72 FR 15080)
The Food and Drug Administration (FDA) is reopening until May 14, 2007, the comment period for the proposed rule published in the Federal Register of January 12, 2007 (72 FR 1582).
- 12 January 2007 (72 FR 1582)
Proposes to prohibit the use of certain cattle material in, or in the manufacture (including processing) of, drugs, biologics, and medical devices intended for use in humans and human cells, tissues, and cellular and tissue-based products (HCT/Ps) (collectively, medical products for humans), and in drugs intended for use in ruminant animals (drugs for ruminants). FDA is also proposing new record keeping requirements for medical products for humans and drugs for ruminants that are manufactured from or otherwise contain material from cattle.
- 2 May 2006 (71 FR 25747)
Withdraws Direct Final Rule of 17 January 2006
- 10 April 2006 (71 FR 18053)
Proposes to amend GMP regulations to include new requirements for the label, colour, dedication, and design of medical gas containers and closures.
- 17 January 2006 (71 FR 25747)
Direct Final Rule exempting most investigational Phase 1 drugs from complying with requirements in FDA’s regulations
- 8 November 2005 (70 FR 67651)
Change of Name; Technical Amendment
- 25 May 2004 (69 FR 29828)
Preamble to final rule requiring human cell, tissue, and cellular and tissue based products (HCT/P)establishments to screen and test donors for risk factors, and clinical evidence of communicable disease agents and disease. The rule clarifies the role of new donor eligibility regulations in relation to existing GMP regulations.
- 31 March 2003 (68 FR 15355)
Withdraws the interim final rule published February 4, 2002, and publishes a final rule in its place. The only change made to part 211 by the interim final rule is preserved with minor wording changes in the new final rule.
- 31 July 2002 (67 FR 49568)
Indefinitely delays the effective date of the changes made on 4 February 2002.
- 26 June 2002 (67 FR 43068)
Corrects two date errors from the notice published on 18 June 2002.
- 18 June 2002 (67 FR 41360)
Announced a public meeting to solicit comments for the development of a regulation on bar code labeling for human drug products, including biological products.
- 4 February 2002 (67 FR 5056)
Interim final rule amending which more clearly defines the kinds of information to be maintained and submitted.
- 6 November 2001 (66 FR 56035)
Changes the address listed for the Center for Food Safety and Applied Nutrition.
- 10 April 2000 (65 FR 18889)
Corrects a footnote which had been incorrectly numbered.
- 30 September 1999 (64 FR 52718)
Proposed to amend the current good manufacturing practice (CGMP) regulations that apply to human cellular and tissue-based products regulated as drugs, medical devices, and/or biological products to incorporate the new donor-suitability procedures into existing good manufacturing practice (GMP) regulations.
- 4 November 1998 (63 FR 59463)
Amended tamper-resistant requirements for OTC to read “tamper-evident” instead of “tamper-resistant.” Modified other tamper-evident requirements.
- 25 March 1998 (63 FR 14355)
Corrected typographical error.
- 19 December 1997 (62 FR 66522)
Revoked regulation (issued 22 April 1997 — see below) on PET radiopharmaceutical drug products which permitted FDA to approve requests from manufacturers of PET drugs for exceptions or alternatives to provisions of the CGMP regulations
- 22 April 1997 (62 FR 19493)
Permitted FDA to approve requests from manufacturers of PET radiopharmaceutical drug products for exceptions or alternatives to provisions of the CGMP regulation. This was later revoked on 19 December 1997 (see above.)
- 20 January 1995 (60 FR 4087)
Clarified the degree of discretion provided to manufacturers to determine whether separate or defined areas of production and storage are necessary, clarified the standard used to determine the degree of scrutiny necessary to check the accuracy of the input to and output from computer systems, exempted investigational new drug products from bearing an expiration date, permitted the use of a representative sampling plan for the examination of reserve samples, and clarified the manufacturer’s responsibilities regarding batch records during the annual evaluation of drug product quality standards.
- 3 August 1993 (58 FR 41348)
Revised labeling requirements with regard to “gang-printed labeling.”
- 29 March 1990 (55 FR 11575)
Updated titles, mailing symbols, and addresses, and made minor editorial changes.
- 12 June 1989 (54 FR 24890)
Corrected cross references, typographical errors, titles and mailing symbols
- 2 February1989 (54 FR 5227)
Increased tamper-resistant requirements for OTC drug products.
- 3 July 1986 (51 FR 24476)
Required manufacturers, packers, and distributors of marketed prescription drug products that are not the subject of approved new drug or abbreviated new drug applications to report to FDA whenever the manufacturer, packer, or distributor receives information about any adverse event that is both serious and unexpected and that is associated with the use of any of its marketed drug products. 3 March1986 (51 FR 7389)
- Part 1 Part 2 Revised procedures and requirements concerning conditions of approval for the manufacture of animal feeds containing new animal drugs.
- 6 March 1985 (50 FR 8993)
Updated organizational references.
- 16 March 1984 (49 FR 9864)
Exempted compressed medical gas products from the requirement that lot or control numbers of the drug product be recorded on distribution records.
- 29 March 1983 (48 FR 13025)
Reduced the time that reserve samples of radioactive drugs containing radio nuclides are required to be retained by manufacturers and exempted reserve samples of these drug products from the annual visual examination requirement.
- 18 March 1983 (48 FR 11429)
Updated §211.48 to include that potable water must meet standards prescribed by EPA in 40 CFR Part 141.
- 5 March 1982 (47 FR 9395)
Updated language in certain references to clearly indicate that an incorporation by reference is intended to provide a complete citation of the material incorporated, and provide a statement about the availability of the incorporated material
- 17 November 1981 (46 FR 56411)
Exempted certain allergenic products from the requirements for expiration dating and stability tests. 29 September 1978 (43 FR 45014)
- Original Final Rule
- Part 1
- Part 2
- Part 3
- Part 4
- Part 5
- Part 6
- 14 February 1963 (28 FR 1447)
Original Proposed Rule