Monday, May 19, 2014

Second Question of the Day May 19, 2014 How mny of they types of enforcement issues seen in Iowa, including the one listed regarding compounded animal preparations, are still occurring everyday in the United States?






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

quoted from here

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