Statutes, codes, and regulations
Maine Administrative Code
Department 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATIONDivision 392 - MAINE BOARD OF PHARMACYPart 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE
Chapter 34 - LICENSURE OF RETAIL SUPPLIERS OF MEDICAL OXYGEN
Section 392-5-34-8 - Compliance with Current Good Manufacturing Practices; Incorporation by Reference

02-392-5 Me. Code R. § 34-8

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Current through 2024-51, December 18, 2024
Section 392-5-34-8 - Compliance with Current Good Manufacturing Practices; Incorporation by Reference
1. Current Good Manufacturing Practices

A retail supplier of medical oxygen that manufactures, processes, packages or holds oxygen as defined in the Federal Food, Drug, and Cosmetic Act and its implementing rules shall comply with the current good manufacturing practices promulgated by the Food and Drug Administration in 21 CFR Parts 210 and 211 (April 1, 2012 edition).

2.Incorporation by Reference

The board hereby incorporates the following documents by reference into this chapter:

A. Title 21 CFR Part 210, "Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding of Drugs; General" promulgated by the U.S. Food and Drug Administration (April 1, 2012 edition). This document is available from the FDA on line at:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

This document may also be obtained from the State Law Library, State House, Augusta, Maine, tel. (207) 287-1600.

B. Title 21 CFR Part 211, "Current Good Manufacturing Practice for Finished Pharmaceuticals" promulgated by the U.S. Food and Drug Administration (April 1, 2012 edition). This document is available from the FDA on line at:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

This document may also be obtained from the State Law Library, State House, Augusta, Maine, tel. (207) 287-1600.

02-392 C.M.R. ch. 5, § 34-8