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Lactation Information and Discussion <[log in to unmask]>
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From:
Liz Brooks <[log in to unmask]>
Date:
Sun, 31 Jul 2005 16:10:20 -0400
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Lactation Information and Discussion <[log in to unmask]>
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Phyllis -- Go to www.iacprx.org/Domperidone, and read the excellent issue 
brief from the Int'l Academy of Compounding Pharmacies, written shortly 
after the domperidone alert.

FDA regulates mass-marketed drugs.  Compounders work on single-patient 
prescriptions, written by an appropriate HCP.   While FDA issued very scary 
cautions about domperidone -- not only to compounders, but directly to OB 
offices -- they were just plain out of their jurisdiction.

The snippet from the issue statement reads:  "Traditionally, FDA regulates 
the manufacturing of drugs and State Boards of Pharmacy regulate the 
practice of pharmacy compounding. Compounding differs from manufacturing in 
that a compounded medication is prepared and dispensed pursuant to a valid 
prescription order from a physician for a specific patient. Manufactured 
drugs are mass marketed and distributed through wholesalers and eventually 
dispensed through pharmacies to patients unknown to the manufacturer."

Jaye Simpson described in her post the ethical, legal and patient-informing 
manner in which to handle discussion of (any) galactagogues with mom.


Liz Brooks, JD, IBCLC
Wyndmoor, PA, USA

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