TYPES OF ENFORCEMENT ISSUES SEEN IN IOWA
Lack of sterility for inhalation and/or nebulizer products
Substituting compounded drug products for commercially available products for economic reasons only and without prescriber approval (e.g., compounding 50mg drug dosages from 100mg tablets)
Improper delegation of pharmacist functions to pharmacy technicians
Compounding errors made by improperly supervised and/or inadequately trained pharmacy technicians
Improper compounding of testosterone products for race dogs
Substandard compounding of injectable fertility products for women
Compounding error resulting in a heparin concentration 250 times higher than what was ordered
Mislabeling and misbranding of compounded drug products
Large-scale manufacturing of commercially available human drug products
Large-scale manufacturing of commercially available animal drug products
Improper compounding of intrathecal products for humans
Failure to follow proper aseptic compounding techniques
Shipping compounded drug products into Iowa without a nonresident pharmacy license (284 shipments between December 1, 2004, and November 13, 2005).
Distributing compounded drug products without a valid prescriber/patient/pharmacist relationship
Lack of required policies and procedures
Failure to implement necessary drug recalls
Obtaining bulk drug substances from unapproved foreign sources (e.g., cromolyn sodium)
Improper shipments of compounded drug products to other states
Failure to conduct required testing of sterile products
Failure to use and maintain proper compounding equipment
Failure to ensure compounding accuracy
Failure to comply with environmental monitoring requirements (e.g., certification of cleanrooms and laminar airflow hoods)
Lack of proper record keeping for compounded drug products
Placing pharmacy employees at risk due to chemical exposure
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