503A permits a pharmacy to compound drugs if:
"Sections 351(a)(2)(B), 352(f)(1) and 355 of this title shall not apply to a drug product if the drug product is compounded for an identified individual patient based on the receipt of a valid prescription order or a notation, approved by the prescribing practitioner, on the prescription order that a compounded product is necessary for the identified patient …."
Pursuant to this language, the compound must be patient specific; it cannot be a compound formula that is simple massed produced for numerous people like has been seen in NECC and the compounded pain cream world where investigations and prosecutions are still on-going. Equally important is that the compound version of the drug must be "medically necessary" for the identified patient not for the population of people--meaning each person it is prescribed to must medically need the specific makeup of the compounded drug he or she gets. Doctors who write the same compounded pain prescription with the exact formula for 1000s and maybe even 100s of patients may come under the microscope and have to produce evidence showing compliance with 503A. Doctors and others prescribing compounded medications pursuant to 503A should document why the specific compounded formula they are prescribing is "medically necessary" for each specific patient. Furthermore, what is essentially a copy of a commercially available is not allowed. The North Carolina Board of Pharmacy, who urges caution in this area, has a great discussion on its website:
North Carolina Board of Pharmacy screen shot found at http://www.ncbop.org/faqs/FAQsDQSA030615.pdf
"Sections 351(a)(2)(B), 352(f)(1) and 355 of this title shall not apply to a drug product if the drug product is compounded for an identified individual patient based on the receipt of a valid prescription order or a notation, approved by the prescribing practitioner, on the prescription order that a compounded product is necessary for the identified patient …."
Pursuant to this language, the compound must be patient specific; it cannot be a compound formula that is simple massed produced for numerous people like has been seen in NECC and the compounded pain cream world where investigations and prosecutions are still on-going. Equally important is that the compound version of the drug must be "medically necessary" for the identified patient not for the population of people--meaning each person it is prescribed to must medically need the specific makeup of the compounded drug he or she gets. Doctors who write the same compounded pain prescription with the exact formula for 1000s and maybe even 100s of patients may come under the microscope and have to produce evidence showing compliance with 503A. Doctors and others prescribing compounded medications pursuant to 503A should document why the specific compounded formula they are prescribing is "medically necessary" for each specific patient. Furthermore, what is essentially a copy of a commercially available is not allowed. The North Carolina Board of Pharmacy, who urges caution in this area, has a great discussion on its website:
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