Requirements for Distributor of Prescription Device

[MBTEX]

We are in the process of distributing a product that was listed as prescription device (elect stethoscope). Most stethoscopes can be purchased over the counter or direct from web etc.. Since they listed it as by prescription. What is the responsibility of the distributor on the device.

Thanks for any help.
Mark

[MIREGMGR]

Regulatory implementation of controls on prescription devices is a state issue. In most states, prescription dispensation of prescription-only devices to lay users is done primarily under the authority of pharmacists, and is regulated by a state Board of Pharmacy or a similar body.

Prescription devices of course also can be sold directly to a physician or dentist, who as a matter of law are empowered to order prescriptions and thus to dispense, or to a business or other organization under the supervision of a physician, such as a hospital or clinic.

Veterinarians and (in some states and clinical settings, in some cases with limited scope) podiatrists, optometrists, nurse practitioners and other advanced clinicians also can order and dispense, and thus can be sold to.

In most states, a distributorship that does not operate with supervisory participation by a licensed professional and hold a state license cannot legally dispense prescription devices to lay users, but can sell such devices to professional users and associated businesses/organizations. Sales of prescription devices should be documented as to buyer and chain of custody.

The relevant part of Texas law is at http://www.statutes.legis.state.tx.u...31.htm#431.005. This is regulated by the Texas Board of Pharmacy, http://www.tsbp.state.tx.us/.

[MBTEX]

In Reply to Parent Post by MIREGMGR

Veterinarians and (in some states and clinical settings, in some cases with limited scope) podiatrists, optometrists, nurse practitioners and other advanced clinicians also can order and dispense, and thus can be sold to.

Would a nurse need to supply a perscription or could they order directly.

Thanks

[MIREGMGR]

I don't work as a distributor, but my understanding is that institutional organizations that regularly buy prescription-only devices for professional use normally would contracturally agree with distributor-suppliers that the organization's authorized purchasers have standing authority, extended from the legal supervisory role of one or more physicians over the organization, to buy such prescription-only devices.

My understanding is that it would be your role as the distributor to have that kind of ongoing blanket agreement prepared for your customers.

In your example, the nurse would be an authorized purchaser, buying under the supervisory authority of a doctor.

I've never seen physical written scripts used in professional-use device distribution. The blanket contractural agreement plus each ongoing purchase order takes the place of individual scripts, documentation-wise.