21 CFR Part 201, Subpart C - Labeling Requirements for Over-the-Counter Drugs

The Food and Drug Administration (FDA or we) is further delaying the effective date of a final rule published in the Federal Register of January 9, 2017. In the Federal Register of February 7, 2017, we delayed until March 21, 2017, the effective date of the final rule. This action further delays the effective date of the rule until March 19, 2018. FDA has received a petition from affected parties which raises questions about the amendments to the regulations regarding “intended uses” and requests that FDA reconsider these amendments. FDA is further delaying the effective date to invite public comment on the important substantive issues raised by the petition and to allow additional time to fully evaluate these issues and any other issues raised in response to this request for comments. FDA is seeking input on some specific questions, and is also interested in any other pertinent information or comments stakeholders would like to provide regarding any aspect of the final rule, or with respect to issues relating to “intended uses” generally.

In accordance with the memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled “Regulatory Freeze Pending Review,” this action delays the effective date of the final rule (“Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding `Intended Uses' ”), which published on January 9, 2017, from February 8, 2017, until March 21, 2017.

The Food and Drug Administration (FDA) is issuing this final rule to describe the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This action is intended to provide direction to regulated industry and to help avoid consumer confusion.

The Food and Drug Administration (FDA) is correcting a final rule entitled “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” that appeared in the Federal Register of August 31, 2016 (81 FR 60169). That final rule amended current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products, and animal drugs. The final rule was published with an incorrect statement in the preamble about the rule's effect on establishments at which investigational drugs are manufactured. This document corrects that error.

The Food and Drug Administration (FDA or the Agency) is amending its current good manufacturing practice (CGMP) and labeling regulations regarding medical gases. FDA is requiring that portable cryogenic medical gas containers not manufactured with permanent gas use outlet connections have gas-specific use outlet connections that cannot be readily removed or replaced except by the manufacturer. FDA is also requiring that portable cryogenic medical gas containers and high-pressure medical gas cylinders meet certain labeling, naming, and color requirements. These requirements are intended to increase the likelihood that the contents of medical gas containers are accurately identified and reduce the likelihood of the wrong gas being connected to a gas supply system or container. FDA is also revising an existing regulation that conditionally exempts certain medical gases from certain otherwise-applicable labeling requirements in order to add oxygen and nitrogen to the list of gases subject to the exemption, and to remove cyclopropane and ethylene from the list.

The Food and Drug Administration (FDA) is amending its regulations governing drug establishment registration and drug listing. These amendments reorganize, modify, and clarify current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products, and animal drugs. The final rule requires electronic submission, unless waived in certain circumstances, of registration and listing information. This rulemaking pertains to finished drug products and to active pharmaceutical ingredients (APIs) alone or together with one or more other ingredients. The final rule describes how and when owners or operators of establishments at which drugs are manufactured or processed must register their establishments with FDA and list the drugs they manufacture or process. In addition, the rule makes certain changes to the National Drug Code (NDC) system. We are taking this action to improve management of drug establishment registration and drug listing requirements and make these processes more efficient and effective for industry and for us. This action also supports implementation of the electronic prescribing provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) and the availability of current drug labeling information through DailyMed, a computerized repository of drug information maintained by the National Library of Medicine.

The Food and Drug Administration (FDA) is reopening the comment period for the notice of proposed rulemaking (NPRM) that appeared in the Federal Register of September 25, 2015. In the NPRM, FDA requested comments on the proposed regulation that describes the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). 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) is proposing regulations to describe the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This action is intended to provide direction to regulated industry and to help avoid consumer confusion.

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 amending its regulations governing the content and format of the “Pregnancy,” “Labor and delivery,” and “Nursing mothers” subsections of the “Use in Specific Populations” section of the labeling for human prescription drug and biological products. The final rule requires the removal of the pregnancy categories A, B, C, D, and X from all human prescription drug and biological product labeling. For human prescription drug and biological products subject to the Agency's 2006 Physician Labeling Rule, the final rule requires that the labeling include a summary of the risks of using a drug during pregnancy and lactation, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy and lactation. The final rule eliminates the “Labor and delivery” subsection because information about labor and delivery is included in the “Pregnancy” subsection. The final rule requires that the labeling include relevant information about pregnancy testing, contraception, and infertility for health care providers prescribing for females and males of reproductive potential. The final rule creates a consistent format for providing information about the risks and benefits of prescription drug and/or biological product use during pregnancy and lactation and by females and males of reproductive potential. These revisions will facilitate prescriber counseling for these populations.

The Food and Drug Administration (FDA) is announcing the establishment of a docket to receive comments on the proposed implementation of FDA's Prescription Drug Labeling Improvement and Enhancement Initiative and on a proposed pilot project relating to the voluntary conversion of labeling to the “Physician Labeling Rule (PLR)” format described in the 2006 FDA final rule, “Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products.” The purpose of the initiative and the pilot project is to enhance the safe and effective use of prescription drugs by facilitating optimal communication through labeling. FDA is seeking public comment on this initiative, and the pilot project, particularly from stakeholders who develop and use prescription drug labeling. Comments received from stakeholders will assist the Agency in identifying and addressing feasibility and implementation issues associated with this initiative.

The Food and Drug Administration (FDA) is delaying the compliance dates for the final rule for over-the-counter (OTC) sunscreen drug products that published in the Federal Register of June 17, 2011 (76 FR 35620). The final rule establishes labeling and effectiveness testing for certain OTC sunscreen products containing specified active ingredients and marketed without approved applications. It also amends labeling claims that are not currently supported by data and lifts the previously-published delay of implementation of the Drug Facts labeling requirements for OTC sunscreens. The 2011 final rule's compliance dates are being delayed because information received after publication of the 2011 final rule indicates that full implementation of the 2011 final rule's requirements for all affected products will require an additional 6 months. This final rule is part of FDA's ongoing review of OTC drug products.