In Office Use Compounded Meds - Clarification on Rules

[Myst1]

Heya,

So I'm taking the Florida MPJE again - but I believe this is relevant to any state - so if anyone knows please tell me...

I'm drawing blanks on compounded meds....

A physician can request from a pharmacy a compounded medication which he/she can administer directly to pt (since he can't dispense it) - is this correct? Essentially the pharmacy label will say In Office Use Only - Not for Resale" or "Compound Drug" for Vets. My questions are...

1- How does the Physician request this from a pharmacy? Through a script? A contract? A phone call?

2- Can a pharmacist compound an "office use only" that's a CIII-IV or CII? I'm assuming definitely no for the CII since you need a DEA 222 - not sure about the CIII-IV since you need an invoice and a federal statement of caution... but I keep reading that a pharmacist can compound a "controlled" substance for in office use only... I'm sooo confused


Any clarification on this issue is appreciated

Thanks

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[Myst1]

To add - since I'm posting... but really my issue is the compounded scripts for in office use - another questions...

For Oral Scripts - for Schedule III it's limited to a 30 day supply (unlike IV-V). That being said, can you still give an ORAL script for Schedule III and authorize refills? Or does it have to be only through an electronic, fax or written script?

Again thanks

 

[Pharmacist15]

Hey! i am also taking the exam soon! what material you are using? To answer your question for how can physician order?

1. i am guessing there has to be a script?
2. I read in seamon notes that No “Office Use” of Controlled substances allowed to be prescribed or dispensed!!
3. A pharmacist may not dispense more than a 30-day supply of a controlled substance listed in Schedule III upon an oral prescription issued i guess physician will authorize the refills and anyways you need the actual rx copy when dispensing controlled substance so that must say refills i'm guessing?

this is what I found under the statues law:

Office use compounding, “Office use” means the provision and administration of a compounded drug to a patient by a practitioner in the practitioner’s office or by the practitioner in a health care facility or treatment setting, including a hospital, ambulatory surgical center, or pharmacy. A pharmacist may dispense and deliver a quantity of a compounded drug to a practitioner for office use by the practitioner in accordance with this section provided:

(a) The quantity of compounded drug does not exceed the amount a practitioner anticipates may be used in the practitioner’s office before the expiration date of the drug;

(b) The quantity of compounded drug is reasonable considering the intended use of the compounded drug and the nature of the practitioner’s practice;

(c) The quantity of compounded drug for any practitioner and all practitioners as a whole, is not greater than an amount the pharmacy is capable of compounding in compliance with pharmaceutical standards for identity, strength, quality, and purity of the compounded drug that are consistent with United States Pharmacopoeia guidelines and accreditation practices.