2012-4784. Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; 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 “Size of Beads in Drug Products Labeled for Sprinkle.” This guidance provides applicants preparing or submitting new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics licensing applications (BLAs) the Center for Drug Evaluation and Research's (CDER's) current thinking on appropriate size ranges for beads in drug products that are labeled to be administered via sprinkling (e.g., capsules or packets containing beads).

In the Federal Register of January 19, 2011 (76 FR 3144), FDA announced the availability of the draft version of this guidance. The public comment period closed on April 19, 2011. A number of comments were received from the public, all of which the Agency considered carefully as it finalized the guidance and made appropriate changes.

DATES:

Submit either 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. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

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

FOR FURTHER INFORMATION CONTACT:

Laurie Muldowney, Center for Drug Evaluation and Research, Food and Drug Administration, Bldg. 51, rm. 4154, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1571.

SUPPLEMENTARY INFORMATION:

 

I. Background

FDA is announcing the availability of a guidance for industry entitled “Size of Beads in Drug Products Labeled for Sprinkle.” This guidance provides applicants preparing or submitting NDAs, ANDAs, and BLAs CDER's current thinking on appropriate size ranges for beads in drug products that are labeled to be administered via sprinkling (e.g., capsules or packets containing beads).

Certain drug products that contain beads within a capsule indicate in the labeling that the capsule can be broken and the internal beads can be sprinkled on soft foods and swallowed without chewing as an alternative administration technique. This is particularly common with drug products designed to have extended- or delayed-release characteristics (i.e., the beads are manufactured to release the drug product at different rates). To make certain that the intended product performance is achieved—whether from a capsule that has been broken or from a packet containing beads—it is important to have reasonable assurance that the patient will be able to swallow the beads (uncrushed) with the food with which the beads are mixed without stimulating the urge to chew. Additional assurances may be needed when the label also includes specific language concerning alternate administration via an enteral feeding tube.

The recommendations in this guidance are based on literature on chewing and swallowing particle size and on Agency experience with NDAs and ANDAs submitted for these dosage forms. This guidance provides the following information related to drug products labeled for sprinkle: Appropriate maximum size for the beads, special considerations for sprinkle drug products that include language in labeling concerning alternate administration via an enteral feeding tube, and bioavailability (BA) or bioequivalence (BE) recommendations.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency's current thinking on the size of beads in drug products labeled for sprinkle. 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) either electronic or written comments regarding this document. It is only necessary to send one set of comments. Identify comments 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. The Paperwork Reduction Act of 1995

This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Information submitted in an NDA, ANDA, or BLA supporting the appropriate size for beads in drug products that are labeled to be administered via sprinkling, including related BA and BE studies, is approved by OMB under control number 0910-0001 for NDAs and ANDAs and control number 0910-0338 for BLAs.

IV. Electronic Access

Persons with access to the Internet may obtain the document at either http://www.fda.gov/​Drugs/​GuidanceComplianceRegulatoryInformation/​Guidances/​default.htm or http://www.regulations.gov.

Dated: February 23, 2012.

Leslie Kux,

Acting Assistant Commissioner for Policy.