
[Federal Register: December 29, 2009 (Volume 74, Number 248)]
[Notices]               
[Page 68845-68846]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29de09-90]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0591]

 
Guidance to Pharmacies on Advance Compounding of Tamiflu Oral 
Suspension to Provide for Multiple Prescriptions; 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 for industry entitled ``Guidance to 
Pharmacies on Advance Compounding of Tamiflu Oral Suspension to Provide 
for Multiple Prescriptions.'' This guidance describes the circumstances 
in which FDA will not object to certain compounding of Tamiflu Oral 
Suspension in advance of receiving prescriptions.

DATES: Submit electronic or written comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed 
adhesive label to assist that office in processing your

[[Page 68846]]

requests. Submit electronic comments on the guidance to http://
www.regulations.gov. Submit written comments on the guidance to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:  Samia Nasr, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 5370, Silver Spring, MD 20993-0002, 301-
796-3409.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Guidance to Pharmacies on Advance Compounding of Tamiflu 
Oral Suspension to Provide for Multiple Prescriptions.'' The increasing 
prevalence of H1N1 infection and resultant increase in demand for 
Tamiflu for Oral Suspension has caused supply difficulties and spot 
shortages of the commercially manufactured Tamiflu for Oral Suspension 
product (12 milligrams (mg)/milliliter (mL)) throughout the country. 
Because of these shortages, compounding of Tamiflu Oral Suspension (15 
mg/mL), as described in the FDA-approved labeling, can ensure that 
patients who have difficulty swallowing tablets have access to Tamiflu 
Oral Suspension when the commercially manufactured Tamiflu for Oral 
Suspension is unavailable.
    This guidance describes the conditions in which FDA will not object 
to certain compounding of Tamiflu Oral Suspension (using Tamiflu 
capsules) in advance of receiving prescriptions. In circumstances where 
there is an actual shortage of commercially manufactured Tamiflu for 
Oral Suspension, FDA will not object if pharmacies compound oral 
suspension from Tamiflu capsules in advance of receiving prescriptions, 
if the amount compounded is commensurate with the number of valid 
prescriptions that the pharmacy can reasonably anticipate receiving 
within the next 24 hours.
    In addition, the guidance provides detailed, step-by-step 
information for the preparation of pharmacy-compounded Tamiflu Oral 
Suspension (final concentration 15 mg/ml) from Tamiflu capsules in 
quantities that are based on patient weight. Information on proper 
storage and a dosing chart for pharmacy-compounded Tamiflu Oral 
Suspension are also provided.
    This guidance is being issued as a Level 1 guidance consistent with 
FDA's good guidance practices regulation (21 CFR 10.115). It is being 
implemented immediately without prior public comment because of the 
shortage of the commercially manufactured Tamiflu for Oral Suspension 
and the potential hazard to the public health. However, the agency 
welcomes comments on the guidance and, if comments are submitted, the 
agency will review them and revise the guidance if appropriate. The 
guidance represents the agency'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. An alternative approach may be used 
if such approach satisfies the requirements of the applicable statutes 
and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) electronic or written comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/
ucm188629.htm.

    Dated: December 23, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-30750 Filed 12-28-09; 8:45 am]

BILLING CODE 4160-01-S
