- Where medically necessary, a compounded drug intended for use in an office setting can and should be prescription-based; purchase-order-like transactions involving compounded, unapproved new drugs should be expressly forbidden.
Because compounded drug formulas are sold or otherwise made available without guarantee, and because components, including brokered, purchased, and repackaged active and inactive pharmaceutical ingredients are also sold without guarantee, the prescription is the foundation where fitness for intended use is constructed. This is not a trivial undertaking, given lack of scientific rigor backing formulas in conjunction with the current state of global supply chain security for chemicals reaching the U.S.
Where a medical decision to use an unapproved new drug is made prior to an office procedure and takes the form of medication problem-solving consistent with pharmaceutical care models, there is an opportunity for patients to be included in an informed decision-making process. In the absence of informed decision-making, patient autonomy is breached and patients are denied the basic human right to self-determination and to protect themselves from unnecessary harm involving compulsory treatment with a drug that does not meet national standards. - September 21, 2014 at 10:51 AM
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
Sunday, September 21, 2014
This Reader's Comment Is Right on Point regarding my IACP office use question!!
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