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U.S. Department of Health and Human
Services
Food and Drug Administration
Office of Policy
Office of Regulatory Affairs
Office of Enforcement
Division of Compliance
Policy
At any time, interested persons may submit written comments regarding this document to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. The comments are to be identified with the title of this guidance document. Such comments will be considered when determining whether to amend the current guidance. For questions regarding the use or interpretation of this guidance, contact the Office of Policy, Paul Rudolf, M.D., J.D. 301-827-3360.
Additional Copies:
Submit written request for a single copy of this guidance to the Division of Compliance Policy (HFC-230), Office of Regulatory Affairs, Food and Drug Administration, 5600 Fishers Lane , Rockville , MD 20857 -001, or FAX your request to 240-632-6861. A copy of the guidance may also be downloaded to a personal computer with access to the Internet. The Office of Regulatory Affairs' home page includes the guidance and may be accessed at http://www.fda.gov/ora/compliance_ref/cpg/default.htm.
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. |
Recently, FDA has received inquiries focusing on whether certain regulatory requirements, including those related to labeling,1 electronic records, and product quality, apply to pharmaceutical manufacturers, repackagers, relabelers, distributors, retailers, or others who participate in feasibility studies and pilot programs (collectively "a study" or "studies") using Radiofrequency Identification (RFID) tags for drugs. This Compliance Policy Guide (CPG) describes how we intend to exercise our enforcement discretion regarding certain regulatory requirements that might otherwise be applicable to such studies. The goal of this CPG is to facilitate the performance of RFID studies and allow industry to gain experience with the use of RFID. As we explained in our report "Combating Counterfeit Drugs" published on February 18, 2004 (which is available on our website at http://www.fda.gov/oc/initiatives/counterfeit/) w e believe that use of RFID technology is critical to ensuring the long-term safety and integrity of the U.S. drug supply.
To the extent that it may be necessary, FDA intends to exercise enforcement discretion as described below for studies that fall within all of the following parameters:
If a study is in compliance with all of the parameters listed above, FDA intends to exercise enforcement discretion by not initiating a regulatory action on the basis that the study fails to comply with any of the following regulatory or statutory requirements (to the extent they apply) of the Federal Food, Drug, and Cosmetic Act (the Act) when those requirements are triggered by the use of RFID in the study. The agency intends to limit its exercise of enforcement discretion to those regulatory issues that are specifically triggered by RFID (that is, triggered by the use of RFID readers, the addition of RFID tags, or the placement of seals):
FDA expects that all of the drugs included in these studies will comply with all applicable provisions of the Act in all other respects, and we are prepared to initiate regulatory action if they do not.
This policy expires automatically
on December 31, 2007, although we may change our policy sooner or deviate
from it in particular cases in order to protect the public health. The December
2007 date should provide sufficient time for industry to gain experience with
RFID technology. Furthermore, in our report "Combating
Counterfeit Drugs" we
stated that we expect RFID technology to be in widespread commercial use in
2007. When RFID is used outside of the parameters described above, we expect
full compliance with all applicable FDA requirements. If RFID technology is
used outside of those parameters and does not comply with applicable requirements,
we do not expect to exercise enforcement discretion.7
Issued: November, 2004
Expires: 12/31/2007
1 Sections 201(k) and 201(m) of the Federal Food, Drug, and Cosmetic Act define "label" and "labeling" respectively. RFID tags may fall within these statutory definitions in certain instances, but we decline to make a definitive pronouncement on that issue for purposes of this guidance.
2At this time the agency does not have the necessary scientific data to extend its exercise of enforcement discretion to RFID studies for all products. We are in the planning phase of scientific collaborative studies with industry and academic institutes to evaluate the potential impact of the exposure to RFID associated electromagnetic energy on the quality of a variety of pharmaceutical products.
3A passive tag draws all of its power from the radio waves transmitted by an RFID reader. A semi-active tag uses a battery to run the microchip's circuitry, but not to communicate with the RFID reader. An active tag is powered entirely by battery to send and receive RFID information.
4Writing to a tag before it is affixed to a container increases the risk of product mix-ups. We suggest that industry and other interested parties explore the feasibility of writing to the tag after it is affixed to the container.
5We believe it is unlikely that studies described in this guidance will trigger any Part 11 requirements. Nevertheless, we intend to exercise enforcement discretion to the extent that Part 11 is triggered. This enforcement discretion policy includes those Part 11 requirements for maintaining the security of electronic records. However, we recommend that parties using "read-write" tags take precautions to ensure the unique serial number and any other information contained in the tag cannot be deleted from the tag or modified in any way (e.g., that the tags be locked).
6All other adulteration requirements relating to product quality continue to apply, including sections 501(b) and (c) of the Act. Therefore, sponsors and participants in RFID studies should make a determination as to what, if any, product quality testing should be performed to assess the effects, if any, of the electromagnetic energy associated with RFID on the drug products used in the study.
7In order to decide whether to exercise enforcement discretion for studies that do not fall within the parameters of this guidance, we would need to review such studies on a case-by-case basis. The Agency is currently reviewing the regulatory requirements that apply to the use of RFID outside of the study context.