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(a) Labeling operations shall be separated physically or spatially from other operations in a manner adequate to prevent mixups.
(b) The labeling operation shall include the following labeling controls:
(1) Labels shall be held upon receipt, pending review and proofing against an approved final copy, to ensure accuracy regarding identity, content, and conformity with the approved copy.
(2) Each type of label representing different products shall be stored and maintained in a manner to prevent mixups, and stocks of obsolete labels shall be destroyed.
(3) All necessary checks in labeling procedures shall be utilized to prevent errors in translating test results to container labels.
(c) All labeling shall be clear and legible.
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.
§ 553 - Rule making
§ 702 - Right of review
§ 703 - Form and venue of proceeding
§ 704 - Actions reviewable
§ 331 to 374 - Omitted
§ 321 - Definitions; generally
§ 331 - Prohibited acts
§ 351 - Adulterated drugs and devices
§ 352 - Misbranded drugs and devices
§ 355 - New drugs
§ 360 - Registration of producers of drugs or devices
§ 360j - General provisions respecting control of devices intended for human use
§ 360 note - Registration of producers of drugs or devices
§ 371 - Regulations and hearings
§ 374 - Inspection
§ 216 - Regulations
§ 262 - Regulation of biological products
§ 263 - Preparation of biological products by Service
§ 263a - Certification of laboratories
§ 264 - Regulations to control communicable diseases
Title 21 published on 10-May-2017 03:43
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 606 after this date.
The Food and Drug Administration (FDA) is amending the biologics regulations by removing the Hepatitis C Virus (HCV) “lookback” requirements regarding review of historical testing records. FDA is taking this action because the HCV “lookback” regulations based on review of historical testing records expired on August 24, 2015, due to the sunset provision provided under the regulation.
The Food and Drug Administration (FDA) is amending the regulations applicable to blood and blood components, including Source Plasma, to make the donor eligibility and testing requirements more consistent with current practices in the blood industry, to more closely align the regulations with current FDA recommendations, and to provide flexibility to accommodate advancing technology. In order to better assure the safety of the nation's blood supply and to help protect donor health, FDA is revising the requirements for blood establishments to test donors for infectious disease, and to determine that donors are eligible to donate and that donations are suitable for transfusion or further manufacture. FDA is also requiring establishments to evaluate donors for factors that may adversely affect the safety, purity, and potency of blood and blood components or the health of a donor during the donation process. Accordingly, these regulations establish requirements for donor education, donor history, and donor testing. These regulations also implement a flexible framework to help both FDA and industry to more effectively respond to new or emerging infectious agents that may affect blood product safety.
The Food and Drug Administration (FDA) is amending its regulations to update address information for the Center for Biologics Evaluation and Research (CBER) as a result of the recent relocation of CBER offices and laboratories to the FDA White Oak campus in Silver Spring, MD, as well as make other related technical revisions. These changes are being made to ensure the accuracy of the Agency's regulations.
The Food and Drug Administration (FDA) is extending the comment period for the proposed rule that appeared in the Federal Register of December 18, 2014. In the proposed rule, FDA requested comments on its proposal to amend its labeling regulations for human prescription drugs and biological products to require that the prescribing information intended for health care professionals that is on or within the package from which the product is dispensed be distributed electronically and not in paper form, except as provided by the proposed rule. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
The Food and Drug Administration (FDA or the Agency) is proposing to amend its prescription drug and biological product labeling regulations to require electronic distribution of the prescribing information intended for health care professionals, which is currently distributed in paper form on or within the package from which a prescription drug or biological product is dispensed. FDA is also proposing that prescribing information intended for health care professionals will no longer be permitted to be distributed in paper form with the package from which a prescription drug or biological product is dispensed, except as provided by this regulation. We are proposing these actions to help ensure that the most current prescribing information is publicly accessible for the safe and effective use of human prescription drugs.
The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of January 3, 2012. In the Federal Register of January 3, 2012, FDA published a final rule entitled “Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma,” which provided incorrect publication information regarding a 60-day notice that announced the availability of an opportunity for public comment on the proposed collection of certain information by FDA pertaining to the final rule. This document corrects this error. Elsewhere in this issue of the Federal Register, FDA is publishing a companion 60-day correction notice.
The Food and Drug Administration (FDA) is revising the labeling requirements for blood and blood components intended for use in transfusion or for further manufacture by combining, simplifying, and updating specific regulations applicable to labeling and circulars of information. These requirements will facilitate the use of a labeling system using machine-readable information that would be acceptable as a replacement for the “ABC Codabar” system for the labeling of blood and blood components. FDA is taking this action as a part of its efforts to comprehensively review and, as necessary, revise its regulations, policies, guidances, and procedures related to the regulation of blood and blood components. This final rule is intended to help ensure the continued safety of the blood supply and facilitate consistency in labeling.