Dear Carmen,

The National Association of Chain Drug Stores (NACDS), on behalf of our members, appreciates the opportunity to present our remarks on the proposed VIPPS Criteria/Information recently released for comment by NABP. We believe that State Boards of Pharmacy are adequately equipped to regulate Internet pharmacies operating in their state making a separate VIPPS certification is unnecessary. However, if NABP intends to implement some type of certification, conceptually, NACDS agrees with most of the language suggested by NABP.

A few concerns remain with the present proposal. It fails to mention what NACDS believes is the single most troubling aspect of Internet pharmacyundefined the existence of a bona fide prescriber-patient relationship. Concerns about Internet pharmacy basically involve whether or not such relationship has been established and that prescription drugs are being accessed through a mechanism that circumvents many state medical practice acts. NACDS feels that the interactions between Boards of Pharmacy and Boards of Medicine should be discussed and included in these recommendations.

We have a few additional issues outlined below.

Licensure.

The proposed parenthetical language includes and defines all qualifying VIPPS pharmacies as "parent corporations and all other entities with common ownership and control." NACDS questions the need for any language that could be construed as limiting NABP's ability to assert that a pharmacy is operating as an Internet pharmacy. Qualifying VIPPS pharmacies should be defined as broadly as possible so that any entity that is operating as an Internet pharmacy will fall within the parameters and will be eligible for VIPPS certification. NACDS would like clarification that the sentence reading "all personsundefined who are engaging in the practice of pharmacy areundefined licensedundefined in all jurisdictions" does not require that every pharmacist practicing in an internet pharmacy must be licensed in each state where the pharmacy does business. NACDS suggests that Internet pharmacist licensure requirements be analogous to mail order requirementsundefined relying on the mandates of each particular state.

Prescriptions.

Throughout the document, reference is made to "a procedure that assuresundefined" "a mechanismundefined" or "a secure and traceable meansundefined" NACDS suggests that this language be modified to allow multiple types of activities that might qualify rather than restricting it to a single acceptable methodology. Moreover, requiring a procedure that "assures" compliance imposes a nearly impossible threshold, and should be replaced with the word "promotes" or similar word with like meaning. NACDS suggests that the clause dealing with generic substitution should be shortened to simply require "undefinedcompliance with applicable generic substitution statutes and regulations" and deleting the remainder. This makes the requirements the same for all pharmacies...community, institutional or Internet.

Communication.

Because "appropriate action" taken with regard to drug reactions and errors will vary with each particular situation, NACDS suggests that the words "at the discretion of the pharmacist" be added to provide clarification, yet flexibility, to deal with the whole range of potential circumstances. The definition of "undue delay" is subject to wide and varied interpretations and should be further clarified. Current law does not require pharmacies to create a procedure to inform patients about disposing of medications, etc. Thus, it is inappropriate to hold Internet pharmacies to a higher standard.

Quality Improvement Programs.

Although many pharmacies have voluntarily established quality assurance programs, they are not required. Internet pharmacies should be treated the same. The section dealing with precursor drugs does not belong in the quality assurance section and should be moved to it's own section.

Reporting to NABP.

NACDS would like clarification that providing a link between the NABP web page and the Internet pharmacy creates no illegal patient referral as defined by federal law. Since a pharmacy must report changes of the pharmacist-in-charge to the State Board of Pharmacy, NACDS feels that reporting this same information to NABP is onerous and unnecessary. This requirement should be removed. NABP through VIPPS is endorsing the legality and legitimacy of the Internet pharmacies but not their services or products. Thus, we suggest the last sentence in this section should read "undefineddoes not imply an endorsement by NABP of the VIPPS Pharmacies' services or products."

NACDS Suggested Additions

The proposal is silent on the single most important aspect of regulating Internet pharmacy. It omits Board of Pharmacy interplay and interactions with state Boards of Medicine and what role, if any, Internet pharmacies have in determining the existence of a "bona fide prescriber-patient relationship." NACDS suggests that this crucial element be included in any guidance enunciated by NABP.

Finally, the methodology omits any reference to licensure by a State Board of Pharmacy and compliance with their posting regulations. This single requirement will do more to expose "fly-by-night operations" than any of the other VIPPS mandates. To give the public even a modicum of confidence and recourse, NACDS believes that any VIPPS pharmacy should comply with the basic posting requirements that normal pharmacies must meet by listing on the homepage of the website: The state where they are physically located and licensed with license number Their address and phone number, including someone to contact with questions The name of the Pharmacist-in-Charge The name of a Board of Pharmacy contact person for complaints including the Board's address and phone number in the state where the Internet pharmacy is physically located. NACDS appreciates the chance to offer our opinion on these controls of this growing and evolving area of pharmacy. We would be happy to discuss our comments with you at any time.

Sincerely,

Brian A. Gallagher, RPh, JD Director of Pharmacy Regulatory Affairs