Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
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Saturday, December 28, 2013
Transcript of IACP Questions and Answers from December 3, 2013 Meeting is now available
So, as I read this, any physician (or hospital) who wants to obtain compounded medications for "office use" (i.e. - no patient-specific prescription before the drug is ordered) - needs to buy it from an OUTSOURCING FACILITY. No if's and's or but's.
I hope state boards of medicine and boards of pharmacy are listening.
Kenneth Woliner, MD www.holisticfamilymed.com
------- Q: Under the new law, does a pharmacy wishing to compound a sterile non-patient specific product have to register under 503B? A: Exact quote from Jane Axelrad: “Section 503A was not changed by the new law and patient specific prescriptions are required under Section 503A. As you know, as you observe, 503B provides a pathway in which hospitals and health care professionals can purchase compounded drugs without prescriptions.” Q: Only under 503B can you provide non-patient specific product? A: Exact quote from Jane Axelrad: “If you want to qualify for the exemption under 503A.”
So, as I read this, any physician (or hospital) who wants to obtain compounded medications for "office use" (i.e. - no patient-specific prescription before the drug is ordered) - needs to buy it from an OUTSOURCING FACILITY. No if's and's or but's.
ReplyDeleteI hope state boards of medicine and boards of pharmacy are listening.
Kenneth Woliner, MD
www.holisticfamilymed.com
-------
Q: Under the new law, does a pharmacy wishing to compound a sterile non-patient specific product have to register under 503B?
A: Exact quote from Jane Axelrad:
“Section 503A was not changed by the new law and patient specific prescriptions are required under Section 503A. As you know, as you observe, 503B provides a pathway in which hospitals and health care professionals can purchase compounded drugs without prescriptions.”
Q: Only under 503B can you provide non-patient specific product?
A: Exact quote from Jane Axelrad: “If you want to qualify for the exemption under 503A.”