Repackaging must be performed according to Current Good Manufacturing Practices (CGMPs).

• A. True
• B. False
• C. Only for controlled substances
• D. Not specified

Answer: (A)

Repackaging is part of the manufacturing process, so it must follow CGMPs to ensure the drug’s identity, strength, quality, and purity. CGMPs require proper facilities and equipment, clean conditions, validated processes, accurate labeling (including drug name, strength, lot number, and expiration date), appropriate storage, and measures to prevent mix-ups and contamination. Documentation and a quality unit that reviews repackaged products are also essential. Since repackaging can affect stability and labeling, these controls apply no matter who performs the work, and it isn’t limited to controlled substances. So the statement is true.