Food, Drug, and Cosmetic Packaging Materials Committee
Medical and Personal Care Products Subcommittee

Subcommittee Chairman: Othmar Schnellenberger, CSP, Ticona
Staff Director: Susan R. Howe

Background/Scope of Purpose:
The Food, Drug and Cosmetic Packaging Materials Committee (FDCPMC) Medical and Personal Care Products Subcommittee's scope of purpose is:

1. to collect, develop, and disseminate among members of the Society information relating to packaging for drugs, personal care products, including cosmetics, toys, medical devices, and, to the extent relevant to Committee members, non-packaging components of drugs, personal care products, including cosmetics, toys and medical devices;
2. to foster relations with other trade associations and Agency personnel interested in these areas; and
3. to advocate the Society's position on issues relating to these areas.

Activities:
The Subcommittee sponsored the Winter programs in 2001 and 2003.

Winter 2001 - The program presented a basic primer on FDA regulation of materials for drug packaging, medical devices and their packaging, and cosmetics packaging, and included an introduction to unique legal and regulatory issues. It was designed to help a company prepare Drug and Device Master Files.

Winter 2003 - The program presented information about regulation and risks related to plastics in drug and medical device applications in the USA and Europe, including Drug and Device Master Files, biomaterials liability, and biocompatibility testing.

Other Activities - As part of the FDCPMC's on-going program of educating FDA, the Medical and Personal Care Products Subcommittee plans to present educational seminars to the Center for Drug Evaluation and Research (CEDR) drug master files reviewers, and the Center for Devices and Radiological Health (CDRH) device master files reviewers. These programs will include discussions on basic polymer chemistry, and expand the discussions on Drug Master Files (DMFs) and Device Master Files (MAFs).

Educational Materials - The Subcommittee develops educational information for SPI Members. Click on the following links for additional information.

• Guideline for the Development of Type III Drug Master Files, December 2003
• Plastics in Pharmaceutical Applications, November 2005
• Plastics Used in Medical Devices, November 2005

Membership:
Membership is open to SPI member companies currently participating in the Food, Drug, and Cosmetic Packaging Materials Committee, and include:

• Resin suppliers who need to know the latest FDA requirements for serving the health care industries;
• Processors (molders as well as extrusion companies) who sell directly to health care, drug and medical companies also need to understand these rules;
• Additive and colorants suppliers also have to understand how to get their raw materials approved for use by both resin suppliers and processors.

November 2005

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