Manufacturers of medical foods must comply with all applicable FDA requirements for foods, including the following regulations:
• Current good manufacturing practice (21 CFR part 110);
• Registration of food facilities (21 CFR part 1 subpart H);
• Thermally processed low-acid foods packaged in hermetically sealed containers (21 CFR part 113);
• Acidified foods (21 CFR part 114); and
• Emergency permit control (21 CFR part 108).