E9-30750. Guidance to Pharmacies on Advance Compounding of Tamiflu Oral Suspension to Provide for Multiple Prescriptions; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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 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.