Louisiana now requires an additional license to provide patients Lyrica samples

ampaphb

Interventional Spine
10+ Year Member
May 13, 2007
4,352
723
New Orleans, LA
Status
Attending Physician
Dear Dr.,


Please accept my apologies for the length of time that it’s taken us respond to your inquiry concerning the need for a Louisiana state-issued “dispensing license” in order to provide samples of Lyrica (pregabalin) to your patients. As we discussed, I asked one of our senior regulatory attorneys to review the relevant sections of the Louisiana Administrative Code to determine if such a requirement exists and, if so, when it applies and received the following response in return:


I have looked at the Louisiana law and it looks like the inspector is, unfortunately, correct. The section of the Louisiana Administrative Code regarding the dispensing of medications by physicians provides an exemption from the need to have a dispensing license for “bona fide medication samples”. However, it carves out controlled substances from that exemption (LAC Title 46, Part XLV, Chapter 65, Section 6501 et.seq.) In fact it prohibits the dispensing of controlled substances entirely as a starting point, but then makes exceptions to that. The exception is that a controlled substance may be dispensed in limited quantities (up to a 7 day supply for Schedule V) But, such 7 day dispensing may only be done by a “registrant”. A “registrant” is a physician who has registered as a dispensing physician under this section of the code. So the bottom line is that a physician need not have dispensing license to dispense “bona fide medication samples”, but if the sample is a controlled substance, then the physician must be a registered dispensing physician. The registration process appears to be fairly simple, however. It’s a form application and $75 fee and that’s about it. But that’s totally up to the doctor if he wants to do that.


As your experience confirms, keeping abreast of individual states’ regulations governing the distribution of controlled substance and legend drug samples is a growing challenge. We regret your discovery of the LA dispensing license requirement, and apologize for the difficulty this has caused you and your staff.


Should you elect not to obtain a state dispensing license in order to be able to continue treating your patients with Lyrica samples, you can arrange for those items to be removed from your office at our expense by calling Pfizer’s Customer Service Team at 800-533-4535, extension 6126. Thank you, once again, for your consideration in this matter.

Sincerely, Jim Batura

Jim C. Batura

Global Samples COE
Telephone: 212-573-1357 (Direct)
212-672-7726 (Fax)
 
OP
ampaphb

ampaphb

Interventional Spine
10+ Year Member
May 13, 2007
4,352
723
New Orleans, LA
Status
Attending Physician
Obtaining a dispensing license puts more of a target on your back. Pain docs already get enough scrutiny, so Mr. Batura's cavalier attitude seems naive, IMHO.
 

clubdeac

10+ Year Member
Aug 16, 2007
3,368
599
Status
Attending Physician
We are stopping Lyrica samples here for this very reason....