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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 2015-04-01
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 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.