Mar
18
I am considering investing in an online pharmacy business.
1. Are there laws in place that regulate online pharmacies differently
from physical brick-and mortar ones ? Federally, State or Locally ?
2. Are there any limitations to the ability to sell and ship
prescription medications interstate ? None of the business would be
ou of the country.Dear Mister Fine,
First of all, before I begin answering your question, based on my
extensive research, let me quote Google Answer's general disclaimer
(also on the bottom of this page), that "Answers and comments provided
on Google Answers are general information, and are not intended to
substitute for informed professional medical, psychiatric,
psychological, tax, legal, investment, accounting, or other
professional advice." In other words, if you want to fully verify the
information hereafter, I suggest you'll contact a health lawyer.
The Clinton Administration tried (and failed) to promote an imitative
to better regulate and control online pharmacies (see
http://www.techlawjournal.com/internet/19991228pr.htm). The current
House of Representatives is also engaged in several attempts to better
regulate online pharmacies, so far without any Federal legislation.
There are several rulings on the subject that in addition to general
law (see henceforth) on the subject, constitute the basis of the
regulations on the subject. This could change, since there are
attempts to regulate online pharmacies as "special case", both in the
state and the federal level. Some states already refer to online
Pharmacies in their relative Controlled Substance Acts. You could see
a list of state-laws at the end of the report "States Begin to
Approach Problem of How to Deal With Growth of Online Pharmacies" at
.
Online Pharmacies as a Private Case of Mail-Order Pharmacies
============================================================
As Katherine K. Knapp, in her review on "Internet Pharmacy Practice"
(APhA 2000 - American Pharmaceutical Association Annual Meeting*,
MedScape, http://www.medscape.com/viewarticle/419161 - you have to
register - for free - to see this article), writes: "Internet
pharmacies are regulated by a complex network of laws and regulations
on both the state and federal levels. Federal agencies that have
jurisdiction over Internet drug sales are the U.S. Food and Drug
Administration (FDA), the Drug Enforcement Agency, the Department of
Justice, the Federal Trade Commission, the Federal Bureau of
Investigation, the Department of Health and Human Services, the U.S.
Customs Service, and the U.S. Postal Service." (ibid.)
She adds, that "Internet pharmacies are governed by the same laws as
mail-order pharmacies, which have been regulated for years. Therefore,
many of the laws and regulations that apply to Internet pharmacies
were in place before these pharmacies came into existence." (ibid.)
A pharmacy has to be licensed in the state in which the facility in
located, in the state where the customer is (it could be registered as
non-resident pharmacy), and in the state where the dispensing facility
is. It also must follow all other procedures regarding RX
(prescription) drugs management, shipment, etc. This answers your
second question - basically, a pharmacy wishing to sell across-state
medication, must adhere to licensure regulations in all states
involved.
Legislature Regarding Online Pharmacies
=======================================
This is problematic regarding some online pharmacies, since the
prescription is actually granted on the basis of a telephone-based
talk or online chat with the patient, and not based on actual physical
examination. Online pharmacies or doctors who gave online
prescriptions were fined and their licensure evoked by the Nevada
State Board of Pharmacy (January 2003) (See: Richard H. Chap,
"Enforcement actions against online pharmacy"
; Timothy Pratt,
"State agency hits online pharmacy with fine" Las Vegas Sun
).
According to the Nevada law (2001), an "illegal Internet pharmacy" is
one that is not licensed by the State of Nevada:
"1. A person who is located within this state and who owns, operates,
controls, profits from or is employed or paid by an illegal Internet
pharmacy shall not:
(a) Fill or refill a prescription for a prescription drug for another
person located within or outside this state; or
(b) Deliver of cause, allow or aid in the deliver of a controlled
substance, imitation controlled substance, counterfeit substance or
prescription drug to another person located within or outside this
state.
2. A person who is located outside this state, who owns, operates,
controls, profits from or is employed or paid by an illegal Internet
pharmacy and who knows or has reasonable cause to believe that another
person is located within this state shall not:
(a) Fill or refill a prescription for a prescription drug for the
other person; or
(b) Deliver or cause, allow or aid in the delivery of a controlled
substance, imitation controlled substance, counterfeit substance or
prescription drug to the other person." (Source: Richard Chapo,
"Online Pharmacy Sales Now Illegal In Nevada?" AdultInternetLaw.com
http://adultinternetlaw.com/articles/online_pharmacy_nv.php)
Other states have similar amendments to their laws, as demonstrated in
the list provided before. Another review of different state laws is
available at: "A SUMMARY ON ACTIVITY SURROUNDING ON-LINE PHARMACIES"
By: Marla Rothouse, Esq.
http://www.ncsl.org/statefed/health/olpharm.htm
Moreover, several criminal processes demonstrate the complexity of the
problem of regulating the business - most of them are actually
fraud/sale without prescription charges
(http://www.usdoj.gov/criminal/cybercrime/ecommerce.html#SOD).
You could see a full review of the current legislation in each state,
and in the federal level, including a relevant analysis, at:
Federal and State Regulation of Online Pharmacies/By Erin Smith Aebel,
Esq. (http://www.healthlawyers.org/Ecommerce/ProductDisplay.cfm?ProductId=44633
Self Regulation: VIPPS
======================
The consequence of the relative lack of regulation on online
pharmacies, created cases, whereas pharmacies sold cross-state
medications without license in the relevant states, sold prescription
medication without physical examination, and sometimes also without a
prescription. As Mary Hillebrand wrote "the online pharmacy business
lacks one central set of regulations by which consumers can identify
safe and unsafe online pharmacists. Regulations vary from state to
state, and many online drugstores are bringing in goods from outside
the country, where regulations are even more suspect, committee
members complained." (Mary Hillebarnd, "Federal Agencies Issue
Warnings About Online Rx Sales" E-Commerce Times, July 30, 1999
).
The FDA reported that it already investigated 372 pharmacies (Source:
Grant Gross, "Online Pharmacies under Investigation" PC World, March
27, 2003, .
See also "House Government Reform Committee Considers Regulation of
online Pharmacies" http://www.nascsa.org/PDF/onlinerxleg303.pdf). The
National Association of Boards of Pharmacy (NABP) developed a system
of licensing pharmacies according to more restrictive standards that
could assure the customer of fair trade. The Verified Internet
Pharmacy Practice Sites (VIPPS) program that began in spring 1999
ensures that by several standards: "To be VIPPS-certified, a pharmacy
must comply with the licensing and inspection requirements of its
state and each state to which it dispenses pharmaceuticals. In
addition, pharmacies displaying the VIPPS seal have demonstrated to
NABP compliance with VIPPS criteria including patient rights to
privacy, authentication and security of prescription orders, adherence
to a recognized quality assurance policy, and provision of meaningful
consultation between patients and pharmacists." (Source: MedScape
Editorial, "Online Pharmacy Regulations"
http://www.medscape.com/viewarticle/408551). You could read more about
VIPPS at the NABP site, http://www.nabp.net/vipps/pharmacy/intro.asp
To sum up, there are several restrictions on online pharmacies. These
are basically the same restrictions and regulations that apply to
mail-order pharmacies, federal and state - from postage regulations,
licensure regulations, FDA, DEA and FTC regulations, custom
regulations (which apply less to a pharmacy which is located in the US
and does not sell outside the US). In most states, and also in the
Federal level, there is no current legislation that applies to online
pharmacies, and the enforcement is based on those laws and
regulations. Several states, however, refer specifically to the
problems posed by online pharmacies.
Aebel's book is an important source for further reading. Another good
source, though a bit outdated, could be
Sara E. Zeman, Regulation of Online Pharmacies: a Case for
Cooperative Federalism, 10 Annals of Health Law 105 (2001)
Search strategy: I searched on the Internet and on legal databases on
the subject, using terms that might assist me:
- Unless dates could be screened, the term "2003", to indicate current
legislation and decisions, was added.
- Search for similar terms: pharmacy, pharmacies ; or online,
internet.
- Search on the different Federal sites.
I hope that answered your question. Please contact me if you need any
clarification on this answer before you rate it.#If you have any other info about this subject , Please add it free.# |
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