[Federal Register: July 26, 2002 (Volume 67, Number 144)]
[Notices]
[Page 48920-48921]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26jy02-95]
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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Draft Guidance for Industry on Inhalation Drug Products Packaged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availability of a draft guidance for industry entitled ``Inhalation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This draft guidance is intended to provide guidance for industry on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 This draft guidance also covers related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issuing this draft guidance to address public health concerns raised by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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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on the draft guidance to the Dockets Management Branch (HFA-305), Food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access to the draft guidance document.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FDA is announcing the availability of a draft guidance for industry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