[Federal Register Volume 67, Number 144 (Friday, July 26, 2002)]
[Notices]
[Pages 48920-48921]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-19020]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0254]


Draft Guidance for Industry on Inhalation Drug Products Packaged 
in Semipermeable Container Closure Systems; 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availability of a draft guidance for industry entitled ``Inhalation 
Drug Products Packaged in Semipermeable Container Closure Systems.'' 
This draft guidance is intended to provide guidance for industry on 
inhalation drug products that are packaged in semipermeable primary 
container closure systems. This draft guidance also covers related 
chemistry, manufacturing, and controls (CMC) considerations. FDA is 
issuing this draft guidance to address public health concerns raised by 
the possible leaching and entry of chemical contaminants into 
inhalation drug products packaged in semipermeable primary container 
closure systems.

DATES:  Submit written or electronic comments on the draft guidance by 
October 24, 2002. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857. Send one self-addressed adhesive label to 
assist that office in processing your requests. Submit written comments 
on the draft guidance to the Dockets Management Branch (HFA-305), Food 
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Badrul Chowdhury or Guirag Poochikian, 
Center for Drug Evaluation and Research (HFD-570), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1050.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Inhalation Drug Products Packaged in Semipermeable Container 
Closure Systems.'' Inhalation drug products used in the treatment of 
patients with asthma or chronic obstructive pulmonary disease may be 
packaged in semipermeable primary container closure systems, such as 
low-density polyethylene. Over time, chemical impurities can accumulate 
in an inhalation drug product packaged in semipermeable primary 
container closure systems as a result of the degradation of formulation 
components, leaching from the container closure system, and/or entry 
from the local environment. Volatile chemical components from the local 
environment, including the secondary packaging, can react with the drug 
product formulation to form different impurities. The clinical 
consequences of chemical contamination of inhalation drug products are 
uncertain; however, given the known sensitivity of patients using these 
products to respiratory irritants and sensitizers, it is possible that 
these chemical contaminates may induce bronchospasm. Because 
bronchospasm is also the indication for which the inhalation drug 
product is used, it is difficult in the clinical setting to establish 
whether bronchospasm after the use of a drug product may be due to 
chemical contaminants or to a patient's underlying disease. Since it is 
possible that chemical contaminants in the inhalation drug products 
used to treat critically ill patients could adversely affect such 
patients, FDA is issuing this draft guidance to provide recommendations 
for inhalation drug products packaged in semipermeable primary 
container closure systems. This draft guidance provides recommendations 
on: (1) Appropriate protective secondary packaging, (2) embossing and/
or debossing of the primary container in lieu of paper labels, and (3) 
general guidance on the number of unit-dose containers to be contained 
within each protective secondary package. These recommendations apply 
to drug products, both those in development and those already approved 
and marketed in the United States.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance 
represents the agency's current thinking on inhalation drug products 
packaged in semipermeable container closure systems. It does not create 
or confer any

[[Page 48921]]

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 Dockets Management Branch (see 
ADDRESSES) written or electronic comments on the draft guidance. Two 
copies of any comments are to be submitted, except that individuals may 
submit one copy. Comments are to be identified with the docket number 
found in brackets in the heading of this document. The draft guidance 
and received comments are available for public examination in the 
Dockets Management Branch 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 
either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: July 17, 2002.
 Margaret M. Dotzel,
 Associate Commissioner for Policy.
[FR Doc. 02-19020 Filed 7-25-02; 8:45 am]
BILLING CODE 4160-01-S