Radiofrequency Identification Feasibility Studies and Pilot Programs for
Guidance for FDA Staff and Industry
Compliance Policy Guides
Radiofrequency Identification Feasibility
Pilot Programs for Drugs
U.S. Department of Health and Human Services
Food and Drug
Office of Policy
Office of Regulatory Affairs
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.
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.
Radiofrequency Identification Feasibility
Studies and Pilot Programs for Drugs
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
- A manufacturer, repackager, relabeler, distributor, retailer, or others
acting at their direction will attach RFID tags (chips and antennae) to only
immediate containers, secondary packaging, shipping containers, and/or pallets
of drugs that are being placed into commerce. There is no limit to the number
of tags or readers that may be used in the study.
- The drugs involved will be limited to prescription or over-the-counter
finished products. The drugs involved will not include those approved under a
Biologics License Application or protein drugs covered by a New Drug
The study need not have a pre-determined time limit or endpoint, except that
tag placement for the study will be completed by December 31, 2007.
- RFID will be used only for inventory control, tracking and tracing of
products, verification of shipment and receipt of such products, or finished
- RFID will not be used to fulfill existing FDA regulatory requirements
(e.g., fulfillment of labeling or Current Good Manufacturing Practice
requirements, provision of chemistry, manufacture, and control information,
storage of information in fulfillment of a regulatory requirement, or
performance of label and product reconciliation).
- RFID will not be used in lieu of current labeling control systems to
ensure correct labeling processes.
- The study will use "passive," "semi-active," or "active" tags.3
- Information will be written to the tag at the time that the tag is
manufactured (e.g., "read only" tags), after the tag is manufactured but
before it is affixed to a drug's container (e.g., "read-write tags"), or after
the tag is affixed to a drug's container.4
The tags will contain a serial number (e.g., an electronic product code) that
uniquely identifies the object to which the tag is attached, and may also
contain other information such as storage and handling conditions, information
from the FDA approved label and labeling, lot number, and product expiration
- The tags will not contain or transmit information for the healthcare
- The tags will not contain or transmit information for the consumer.
- The tags will not contain or transmit advertisements or information about
product indications or off-label product uses.
- A seal containing a logo, an inventory control message unrelated to the
product (e.g., a message informing the custodian that the package contains an
RFID tag), and/or a unique serial number may be placed over the RFID tag or
elsewhere on a drug's immediate container, secondary packaging, and/or
- The addition of the RFID tag and seal will not block, obscure, or alter
any of the product's existing and approved label and labeling information.
- The RFID tag will not substitute for, replace, or interfere with a linear
bar code required pursuant to 21 C.F.R. § 201.25.
- Participants will "read" the tags as needed to identify the product and/or
conduct the study.
- The tag readers will work by emitting electromagnetic energy at radio
frequencies of 13.56 megahertz, 902-928 megahertz, or 2.4 gigahertz, and at
powers in compliance with regulatory requirements of the Federal
Communications Commission (i.e., 1-4 watts effective isotropically radiated
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):
- Any RFID-triggered requirements of 21 C.F.R. & 314.70 and section 506A
of the Act.
- Any RFID-triggered submission requirements under 21 C.F.R. part 314 and
section 505 of the Act, except for field alert report
- Any RFID-triggered requirements of 21 C.F.R. part 11.5
- Any RFID-triggered requirements of 21 C.F.R. parts 210 and 211 and section
501(a)(2)(B) of the Act (current Good Manufacturing Practices).6
- Any RFID-triggered requirements of 21 C.F.R. part 207 and section 510 of
the Act (Registration and Listing).
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
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
Issued: November, 2004
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.