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Standard Partnership Agreements

1. Agreement to Establish Partnership.

   The Baltimore District of the Food and Drug Administration and the Department of Medical Services of the District of Columbia of agree to plan and schedule joint statutory inspectional coverage of the medical gas repacking industry in the District of Columbia.

2. Partnership Purpose and Goals.

   To cover the entire medical gas industry in the District of Columbia without duplication of effort and to achieve maximum consumer protection. This agreement covers the period 10/1/98 - 9/30/99.

3. Program Areas and Activities for Partnership.
   1. The program area for partnership includes the Federal and State statutory inspectional requirements for domestic CGMP drug manufacturers/repackers. Specifically identified are those firms which produce medical gases within the District of Columbia. Inspectional priorities are as follows:
      1. Firms with previously violative histories.
      2. Firms not inspected within the last two years or longer.
      3. Firms having unusually complex operational technologies.
   2. Cooperating Agency Contacts.
      1. FDA.
      2. Sidney Rogers - Medical Gas Program Monitor for Baltimore District.
      3. District of Columbia. Sylvia Roberts - Department of Medical Services Program Supervisor.
   3. Statutory Basis for Partnership Agreement.

      FDA - Federal Food Drug and Cosmetic Act: Section 501 (a)(2)(b), 21 CFR 210 & 211.

      District of Columbia - State Public Health Code.

      The requirements of the Federal Food, Drug and Cosmetic Act have been adopted by the District of Columbia by reference in their Public Health Code and are, therefore, equivalent requirements.

4. Responsibilities.

   Joint -

   • Each party will provide their Official Establishment Inventories of Medical gas firms to produce a combined list.
   • Ten inspections will be conducted jointly by the parties during this agreement.
   • Each party will share inspection reports for inspections not performed jointly.
   • Coordinate legal actions before they are carried out.
   • Coordinate anticipated publicity.
   • Conduct a one-week training course in CGMP compliance issues and inspection techniques on medical gases to assure consistency of inspection efforts between FDA and District of Columbia inspectors.
   • Evaluate work results.

   FDA -

   • Inspect 25% of the medical gas industry in the District of Columbia listed on the combined inventory during the partnership period.
   • Provide funding for training of FDA and District of Columbia inspectors who will conduct inspections.
   • Provide instructors for joint training.

   District of Columbia -

   • Inspect 75% of the medical gas industry in the District of Columbia listed on the combined inventory.
   • Provide a training site for joint inspection training.
   • Provide instructors for joint training.
5. Planned Resources.
   1. Funding.
      • Training - $5,000 to be funded by FDA.
      • Partners will individually fund inspections performed from operating budgets.
   2. Personnel.
      • FDA will provide 5 investigators to perform inspections.
      • FDA will provide 2 instructors for training purposes.
      • District of Columbia will provide 12 inspectors to perform inspections.
      • District of Columbia will provide 1 instructor for training purposes.
6. Assessment Mechanisms.
   1. Track EIs performed with classifications
   2. Database of 483s or lists of adverse findings showing specific adverse findings and frequency.
   3. Develop a database to reflect costs of EIs, training, overhead so average cost/EI could be calculated.
   4. Interim evaluations of progress occur quarterly by joint FDA/District of Columbia project coordinators meeting to review data (i.e. teleconference, face-to-face meeting).
   5. Final evaluations occur within 30 days after 9/30/99. Evaluation occurs in the form of a narrative report reflecting the extent to which goals of eliminating Federal/State duplication of inspections and maximizing consumer protection by assessment of individual databases and drawing conclusions. The evaluation will be performed jointly by the FDA and District of Columbia project coordinators. Again, the joint effort can occur by teleconference or face-to-face meeting.
7. Conclusions and Recommendations.

   Based on the final evaluations performed, the Project Coordinators will jointly prepare several options for follow-up agency actions, if and when appropriate, for approval by the signatories to this agreement.

8. Signatures of Responsible Parties (and date signed):

   FOR FDA:
   Sidney H. Rogers
   District Director
   Baltimore District
   

   Date _____________

    

   FOR THE DISTRICT OF COLUMBIA:
   Zelda O'Brien
   Director, Dept. of Medical Services
   The Government of the District of Columbia
   

   Date ______________

    

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