Saturday, June 1, 2013

Idaho Board of Pharmacy 2013 Pharmacy Administrative Rule and Statue Changes-Several Relate to Compounding

2013 Pharmacy Administrative Rule and Statute
On April 4, 2013, four dockets of rule changes took effect, as
detailed in the March 2013 Newsletter. On July 1, 2013, the following
changes to an administrative rule and sections of Idaho Code
will become effective. Copies of the pertinent docket of rules and
bills are available on the Idaho State Board of Pharmacy’s Web site.
Engrossed versions of Idaho Code and the Board’s administrative
rules are expected to be available later this summer.
House Bill 239 gives the Board statutory authority to address
compounding and the distribution of compounded drug product
in rule, as well as extending to all pharmacies the sale of minimal
quantities of prescription drugs to licensed practitioners for office
use, without required wholesale licensure. Please see the Board’s
Web site for a draft version of such subsequent rules; the Board is
currently accepting public comment on this draft.
House Bill 16 allows a pharmacist or practitioner to furnish another
pharmacist or practitioner information legally obtained from
the Board’s Prescription Monitoring Program database.
House Bill 17 (HB 17) mainly expands the practice of pharmacy
into Idaho, with considerably more regulation of such persons,
practices, and practice sites; however, the bill also deletes outdated
practices and contains several non-substantive changes. HB 17
merges the Out-of-State Mail Service Pharmacy Act into the Idaho
Pharmacy Act, and defines central drug outlet, central pharmacist,
mail service pharmacy, nonresident, pharmacist-in-charge (PIC),
and centralized pharmacy services, which means the processing by
a central drug outlet or central pharmacist of a request from another
pharmacy to fill, refill, or dispense a prescription drug order, perform
processing functions, or provide cognitive or pharmaceutical care
services. Each function may be performed by the same or different
persons and at the same or different locations. All persons and
business entities engaging in the practice of pharmacy into Idaho,
including but not limited to pharmaceutical care services, must be
licensed and registered, except nonresident pharmacists practicing
pharmacy into Idaho who are employed by and practicing for an
Idaho registered nonresident mail service pharmacy. All nonresident
mail service pharmacies and central drug outlets must also have a
PIC or director who is licensed or registered by the Board.
Please note that nonresident pharmacist registration is a lower
standard when compared to pharmacist licensure, as pharmacist
registration does not require an applicant to reciprocate through
the National Association of Boards of Pharmacy® or pass an Idahobased
Multistate Pharmacy Jurisprudence Examination®. However,
the Board may take any action against a nonresident pharmacist
registrant that it can take against a pharmacist licensee for violations
of the laws of Idaho or the state in which the pharmacist resides.
Additionally, the Board may take any action against a nonresident
drug outlet that it may take against its agents and employees. A successful
applicant for a nonresident central drug outlet, mail service
pharmacy, or pharmacist registration or licensure must comply with
the Board’s laws and rules unless compliance would violate the laws
or rules in the state in which the registrant is located, except a technician
shall not exceed the practice limitations for technicians in Idaho
and a pharmacist shall only substitute and generically select drug
products in accordance with Idaho law and shall not exceed Idaho’s
pharmacy staffing ratio. Additionally, the Board may issue an order
likewise suspending, revoking, restricting, or otherwise affecting
the license or registration in Idaho, without further proceeding, as
Drug Enforcement Administration or another state licensing board
with authority over a licensee’s or registrant’s professional license
or registration has issued. Also, if the Board conducts a nonresident
inspection, the nonresident drug outlet shall pay the costs of such
inspection. Lastly, HB 17 reestablishes the original out-of-state mail
service pharmacy fees for all nonresident mail service pharmacies
and central drug outlets: $500 for initial registration and $250 for
Docket 27-0101-1205 reiterates some of HB 17 for ease of reading
the rules. Remote office location is defined and allowed with certain
security requirements. While the category of “telepharmacy across
state lines” is absorbed into the new nonresident rule and statute, the
existing $250 registration fee for “telepharmacists across state lines”
is expanded to all pharmacist registrants, but pharmacist licensure
fees remain unchanged. New Rule 029 details which pharmacists
practicing pharmacy in or into Idaho need to be registered or licensed.
The registration category of “telepharmacist across state
lines,” who practice from nonresident institutional pharmacies, is
expanded to all nonresident pharmacists who practice from within
a pharmacy. Unless statutorily exempted (a nonresident pharmacist
working for a mail service pharmacy) or a nonresident PIC or director,
all other pharmacists practicing pharmacy in or into Idaho
must be Idaho licensed, including those practicing from a central
drug outlet that is not a pharmacy and remote office locations. Upon
applying, nonresident central drug outlets and mail service pharmacies
must submit an executive summary describing the centralized
pharmacy services to be performed.
Docket 27-0101-1205 also addresses practice standards. For
example, Rule 320 mandates that the independent practice of
pharmacy is not to be construed to excuse compliance with the
rules governing centralized pharmacy services. The independent
practice of pharmacy rule’s minimal standards are designed to
recognize and regulate pharmacist activities outside of a drug
outlet or institutional facility, such as at a health fair. Rule 610’s
expanded regulation pertains to centralized pharmacy servicessuch as
providing cognitive services for an institutional pharmacy,
remote data entry, and central fill. A pharmacy may centralize
pharmacy services to another Idaho registered business entity, to
be performed at a pharmacy, central drug outlet, or remote office
location, pursuant to a written contract, policies and procedures,
certain training, appropriate communication, a common electronic
file (or other secure technology), a continuous quality improvement
program, audit trail documentation, and privacy considerations. For
an institutional pharmacy, centralized pharmacy services are only
allowed for the limited purpose of ensuring that drugs or devices
are attainable to meet the immediate needs of patients or residents
of the institutional facility.
quoted from Idaho Board of Pharmacy June 2013 Newsletter

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