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2003 SESSION

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HB 2204 Pharmacists' compounding of drug products.

Introduced by: S. Chris Jones | all patrons    ...    notes | add to my profiles

SUMMARY AS PASSED: (all summaries)

Pharmacists' compounding of drug products. Revises the requirements for compounding of drugs by pharmacists. This bill provides, among other matters, clear parameters for permitted pharmacies in Virginia to engage in the compounding of drug products. The bill includes (i) definitions of "bulk drug substance," and "compounding," and modifications to other Drug Control Act definitions; (ii) clarification that pharmacists may compound pursuant to valid prescriptions or in anticipation of valid prescriptions according to historical prescribing patterns; (iii) labeling requirements for compounded drugs, both those drugs dispensed pursuant to single prescriptions and those drugs compounded in anticipation of receiving valid prescriptions; (iv) restrictions on distribution that clarify that pharmacists cannot distribute to other pharmacies or commercial entities but may deliver compounded products to alternative delivery locations and provide compounded products to practitioners to administer to their patients in the course of their professional practice; (v) requirements for performance and supervision of the compounding process; (vi) a requirement for a policy and procedure manual when the levels of compounding are associated with higher risk for contamination or radiopharmaceuticals or dosage forms that are dose-critical or specialized preparations, such as slow-release products or transdermal patches; (vii) rules for the use of bulk drug substances in compounding; (viii) restrictions on the compounding of drugs that have been removed from the market by the FDA or found to be unsafe and on the compounding of large amounts of any drug product that are essentially copies of commercially available; and (ix) strict recordkeeping criteria. Physicians who are permitted to dispense or who engage in compounding must also comply with the requirements. Permitted pharmacies will not be required to obtain licenses as wholesale distributors if the wholesale distributions do not exceed five percent of the gross annual sales of the pharmacy or the wholesale distributions of Schedules II through V controlled substances do not exceed five percent of the total dosage units of such substances dispensed annually by the pharmacy.


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