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
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.”
1 comment:
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.”
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