[Federal Register Volume 65, Number 14 (Friday, January 21, 2000)]
[Notices]
[Pages 3463-3464]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-1407]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D-4956]


Guidance for Industry: Alternative to Certain Prescription Device 
Labeling Requirements; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a guidance entitled ``Alternative to Certain 
Prescription Device Labeling Requirements.'' The FDA Modernization Act 
of 1997 (FDAMA) amended the Federal Food, Drug, and Cosmetic Act (the 
act) to require, at a minimum, that before dispensing, the labels of 
prescription drug products contain the symbol ``Rx only'' instead of 
the textual prohibition ``Caution: Federal law prohibits dispensing 
without prescription.'' Through this guidance, the Center for Devices 
and Radiological Health (CDRH) announces that, in its enforcement 
discretion, it will apply a similar amended standard for labeling of 
prescription devices.

DATES:  Submit written comments concerning the guidance document at any 
time.

ADDRESSES:  Submit written comments on the guidance document to the 
contact person listed below. Submit written requests for single copies 
on a 3.5" diskette of the guidance document entitled ``Alternative to 
Certain Prescription Device Labeling Requirements'' to the Division of 
Small Manufacturers Assistance (HFZ-220), Center for Devices and 
Radiological Health, Food and Drug Administration, 1350 Piccard Dr., 
Rockville, MD 20850. Send two self-addressed adhesive labels to assist 
that office in processing your request, or fax your request to 301-443-
8818. See the SUPPLEMENTARY INFORMATION section for information on 
electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT:  Casper E. Uldriks, Center for Devices 
and Radiological Health (HFZ-300), Food and Drug Administration, 2094 
Gaither Rd., Rockville, MD 20850, 301-594-4692.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of the guidance ``Alternative to 
Certain Prescription Device Labeling Requirements.'' Section 126 of 
Title I of FDAMA (Public Law 105-115), signed into law by President 
Clinton on November 21, 1997, amends prescription drug labeling 
requirements required by section 503(b)(4) of the act (21 U.S.C. 
353(b)(4)) to require, at a minimum, that prior to dispensing, the 
label of prescription products contain the symbol ``Rx only.'' The 
agency announced this change for prescription drugs in the Federal 
Register of March 13, 1998 (63 FR 12473).
    FDAMA did not direct the agency to amend the prescription device 
labeling regulation, found in the Code of Federal Regulations (CFR) at 
Sec. 801.109(b)(1) (21 CFR 801.109 (b)(1)); however, CDRH believes 
manufacturers, repackers, relabelers, and distributors of prescription 
devices may wish to use the same symbol statement, ``Rx only,'' as an 
alternative to the text required by regulation. This alternative 
simplifies the labeling and still conveys, by custom and practice, 
essentially the same meaning. CDRH would like to minimize the burden on 
manufacturers, repackers, relabelers, and distributors that face many 
labeling requirements. Therefore, the agency will not object to the use 
of the statement ``Rx only'' as an alternative to the prescription 
device statement required by Sec. 801.109(b)(1). This means that FDA 
will not view the use of the alternative symbol statement ``Rx only'' 
as a violation of the labeling requirements for prescription devices 
that would cause the device to be considered misbranded under section 
502(f)(1) of the act (21 U.S.C. 352(f)(1)).
    The alternative labeling may be implemented at the discretion of 
the firm responsible for labeling. Devices already in commercial 
distribution may immediately implement the labeling change. Devices 
undergoing premarket review may implement the change once the firm is 
notified the product may be marketed. In vitro diagnostic devices also 
fall within the scope of this guidance.

II. Significance of Guidance

    This guidance document represents the agency's current thinking on 
the use of alternative labeling to prescription device labeling 
requirements. It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the applicable statute, 
regulations, or both.
    The agency has adopted Good Guidance Practices (GGP's), which set 
forth the agency's policies and procedures for the development, 
issuance, and use of guidance documents (62 FR 8961, February 27, 
1997). This guidance document is issued as a Level 1 guidance 
consistent with GGP's. Public comment before implementation of this 
guidance is not necessary because the guidance presents a less 
burdensome policy that is consistent with the public health.

III. Electronic Access

    In order to receive ``Alternative to Certain Prescription Device 
Labeling Requirements'' via your fax machine, call the CDRH Facts-On-
Demand (FOD) system at 800-899-0381 or 301-827-0111 from a touch-tone 
telephone. At the first voice prompt press 1 to access DSMA Facts, at 
the second voice prompt press 2, and then enter the document number 
1150 followed by the pound sign (#). Then follow the remaining voice 
prompts to complete your request.
    Persons interested in obtaining a copy of the guidance may also do 
so using the

[[Page 3464]]

Internet. CDRH maintains an entry on the Internet for easy access to 
information including text, graphics, and files that may be downloaded 
to a personal computer with access to the Internet. Updated on a 
regular basis, the CDRH home page includes the guidance ``Alternative 
to Certain Prescription Device Labeling Requirements,'' device safety 
alerts,  Federal Register reprints, information on premarket 
submissions (including lists of approved applications and 
manufacturers' addresses), small manufacturers' assistance, information 
on video conferencing and electronic submissions, mammography matters, 
and other device-oriented information. The CDRH home page may be 
accessed at http://www.fda.gov/cdrh. The guidance ``Alternative to 
Certain Prescription Device Labeling Requirements'' will be available 
at http://www.fda.gov/cdrh/oc.

IV. Comments

    Interested persons may at any time, submit written comments 
regarding this guidance document to the contact person listed above. 
Such comments will be considered when determining whether to amend the 
current guidance.

    Dated: January 9, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-1407 Filed 1-20-00; 8:45 am]
BILLING CODE 4160-01-F