Dispensing/Distributing Controlled Substances to Physicians

[Doctor Rock]

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I just started working at a home infusion pharmacy and we had a request for a CIII to be transfered to a prescriber for office use. The pharmacist adimantly refused because the CSA act says,
"To be valid, a prescription for a controlled substance must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. The practitioner is responsible for the proper prescribing and dispensing of controlled substances. A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients."

I looked into this further and found the following in the CSA act:
"Controlled Substance Distribution by a Pharmacy – “Five Percent Rule” A pharmacy registered to dispense controlled substances may distribute such substances (without being registered as a distributor) to another pharmacy or to a registered practitioner for the purpose of general dispensing by the practitioner to patients, provided that the following conditions are met:
1. The pharmacy or practitioner that will receive the controlled substances is registered under the CSA to dispense controlled substances;
2. The distribution is recorded by the distributing practitioner in accordance with 21 C.F.R. § 1304.22(c) and the receipt is recorded by the receiving practitioner in accordance with 21 C.F.R. § 1304.22(c);
3. If the pharmacy distributes a schedule II controlled substance, it must document the transfer on an official order form (DEA Form 222) or the electronic equivalent. For instructions on completing this form, see Section VIII, Ordering Controlled Substances.
4. “Five Percent Rule” - total number of dosage units of all controlled substances distributed by a pharmacy may not exceed five percent of all controlled substances dispensed by the pharmacy during a calendar year. If at any time the controlled substances distributed exceed five percent, the pharmacy is required to register as a distributor."

Is it legal to do?

 

[cycloketocaine]

I just started working at a home infusion pharmacy and we had a request for a CIII to be transfered to a prescriber for office use. The pharmacist adimantly refused because the CSA act says,
"To be valid, a prescription for a controlled substance must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. The practitioner is responsible for the proper prescribing and dispensing of controlled substances. A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients."

I looked into this further and found the following in the CSA act:
"Controlled Substance Distribution by a Pharmacy – “Five Percent Rule” A pharmacy registered to dispense controlled substances may distribute such substances (without being registered as a distributor) to another pharmacy or to a registered practitioner for the purpose of general dispensing by the practitioner to patients, provided that the following conditions are met:
1. The pharmacy or practitioner that will receive the controlled substances is registered under the CSA to dispense controlled substances;
2. The distribution is recorded by the distributing practitioner in accordance with 21 C.F.R. § 1304.22(c) and the receipt is recorded by the receiving practitioner in accordance with 21 C.F.R. § 1304.22(c);
3. If the pharmacy distributes a schedule II controlled substance, it must document the transfer on an official order form (DEA Form 222) or the electronic equivalent. For instructions on completing this form, see Section VIII, Ordering Controlled Substances.
4. “Five Percent Rule” - total number of dosage units of all controlled substances distributed by a pharmacy may not exceed five percent of all controlled substances dispensed by the pharmacy during a calendar year. If at any time the controlled substances distributed exceed five percent, the pharmacy is required to register as a distributor."

Is it legal to do?

No. If a practitioner wishes to dispense controlled substances to patients, they must order them directly from a supplier. Prescribing prescriptions "for office use" is not permissible.

 

[Doctor Rock]

What if you don't receive a script and they want you to act as a distributor, transferring it to them?

 

[cycloketocaine]

What if you don't receive a script and they want you to act as a distributor, transferring it to them?

You cannot act as a distributor in this circumstance. The CSA explicitly states that "for office use" prescribing of controlled substances is prohibited. End of story.

 

[Doctor Rock]

Sorry for being ignorant, but why have the 5 percent rule listed then? If it is prohibited, why have the additional section?

 

[cycloketocaine]

Sorry for being ignorant, but why have the 5 percent rule listed then? If it is prohibited, why have the additional section?

The five percent rule only applies to the transfer of controlled substances from one pharmacy to another.

 

[Doctor Rock]

Again, sorry to keep talking, but it specifically states "to a registered practitioner for the purpose of general dispensing by the practitioner to patients". This is where I am confused. To me, it reads as though the pharmacy could act as a distrubutor and give it to the practitioner. But if there is a script, then the pharmacy cannot "fill" the prescription.

 

[cycloketocaine]

Again, sorry to keep talking, but it specifically states "to a registered practitioner for the purpose of general dispensing by the practitioner to patients". This is where I am confused. To me, it reads as though the pharmacy could act as a distrubutor and give it to the practitioner. But if there is a script, then the pharmacy cannot "fill" the prescription.

In this circumstance, a registered practitioner can only be a pharmacy. The "Guide to Federal Pharmacy Law" by Reiss and Hall explains this in great detail and clarifies the law quite nicely.

 

[Doctor Rock]

Thanks! I will look it up when I locate my book

 

[Old Timer]

The five percent rule only applies to the transfer of controlled substances from one pharmacy to another.

I beg to differ:

Controlled Substance Distribution by a Pharmacy – "Five Percent Rule" A pharmacy registered to dispense controlled substances may distribute such substances (without being registered as a distributor) to another pharmacy or to a registered practitionerfor the purpose of general dispensing by the practitioner to patients , provided that the following conditions are met:
1. The pharmacy or practitioner that will receive the controlled substances is registered under the CSA to dispense controlled substances;
2. The distribution is recorded by the distributing practitioner in accordance with 21 C.F.R. § 1304.22(c) and the receipt is recorded by the receiving practitioner in accordance with 21 C.F.R. § 1304.22(c);
3. If the pharmacy distributes a schedule II controlled substance, it must document the transfer on an official order form (DEA Form 222) or the electronic equivalent. For instructions on completing this form, see Section VIII, Ordering Controlled Substances.
4. "Five Percent Rule" - total number of dosage units of all controlled substances distributed by a pharmacy may not exceed five percent of all controlled substances dispensed by the pharmacy during a calendar year. If at any time the controlled substances distributed exceed five percent, the pharmacy is required to register as a distributor."

It just means you use an invoice and not a prescription number for billing....

 

[ifillrxs]

I beg to differ:

Controlled Substance Distribution by a Pharmacy – “Five Percent Rule” A pharmacy registered to dispense controlled substances may distribute such substances (without being registered as a distributor) to another pharmacy or to a registered practitionerfor the purpose of general dispensing by the practitioner to patients , provided that the following conditions are met:
1. The pharmacy or practitioner that will receive the controlled substances is registered under the CSA to dispense controlled substances;
2. The distribution is recorded by the distributing practitioner in accordance with 21 C.F.R. § 1304.22(c) and the receipt is recorded by the receiving practitioner in accordance with 21 C.F.R. § 1304.22(c);
3. If the pharmacy distributes a schedule II controlled substance, it must document the transfer on an official order form (DEA Form 222) or the electronic equivalent. For instructions on completing this form, see Section VIII, Ordering Controlled Substances.
4. “Five Percent Rule” - total number of dosage units of all controlled substances distributed by a pharmacy may not exceed five percent of all controlled substances dispensed by the pharmacy during a calendar year. If at any time the controlled substances distributed exceed five percent, the pharmacy is required to register as a distributor."

It just means you use an invoice and not a prescription number for billing....

I agree. I interpret this as selling a controlled substance from a DEA registered pharmacy to a DEA registered practitioner. This would be distribution not dispensing. No patient info is involved.

 

[Doctor Rock]

I agree. I interpret this as selling a controlled substance from a DEA registered pharmacy to a DEA registered practitioner. This would be distribution not dispensing. No patient info is involved.

I researched this more in Pharmacy Practice and the Law book by Abood. It is legal to do this, but the practitioner must be registered to dispense with the DEA.