2. I have no relationships with
commercial interests related to the
content of my presentation.
3. Objectives
Define and apply recent statutory changes
affecting the practice of pharmacy.
Describe and apply recent rules-based
changes affecting the practice of
pharmacy.
List and apply commonly confused legal
precepts to the practice of pharmacy.
4. State Bills Introduced Concerning
Pharmacy
S.112, introduced by Senator Purcell
To “disapprove” Board rule 21 NCAC 46.1418,
Supervision of Unit Dose Medication Systems
No co-sponsors
Presently sitting in the Senate Health Care
Committee
No action has been taken on the bill
5. Pharmacy Technician
Opportunities in the Inpatient
Hospital Setting
Board has adopted a rule that would pharmacy
technicians with advanced training in the
hospital practice setting to shoulder more
responsibilities in various unit dose activities.
Requires the technician to obtain an associate’s
level degree in pharmacy technology (programs
underway in several NC community colleges)
Is voluntary for hospitals. A technician does not
have to obtain advanced training to be a
technician at a hospital – only to take on the
additional responsibilities specified in the rule.
6. Pharmacy Technician
Opportunities in the Inpatient
Hospital Setting
The rule cleared Rules Review Commission and
has been published.
A small handful of pharmacists and others,
however, demanded legislative review of the
rule.
Rule would have gone into effect in late March
2011 if S.112 had not been introduced
Fate of the rule now depends on S.112
If passed, the rule is killed
If affirmatively voted down, rule goes into effect
If S.112 dies without a vote, rule would go into effect
when the General Assembly adjourns
7. Rule Process
This rule was passed after 17 public actions at
Board meetings over a five-year period.
The rule was passed after two pilot studies at
North Carolina hospitals (spanning three and
two years, respectively) demonstrated safety.
The rule was passed after notice, comment, and
public hearing.
Many comments were provided to, and considered
by, the Board.
8. What the Rule Is Not
A great deal of misinformation has circulated
regarding the rule in recent months.
It does NOT permit “technician dispensing.”
It is strictly limited to inpatient hospitals.
It is voluntary for hospital implementation.
It does not apply to any other pharmacy practice
setting.
There is no pilot project, proposed rule, or even
discussion occurring at the Board to extend the
rule beyond in the inpatient hospital setting.
9. Pharmacist Vaccination
S.246, introduced by Senator Hartsell, co-
sponsored by Senators Atwater and
Mansfield
Referred to Senate Health Care Committee
Expand vaccination authority by
pharmacists
10. Backdrop: Flu Vaccine
Administration Emergency Rule
Pharmacists were always able to administer H1N1
vaccine under the existing vaccination
Per a request from Dr. Jeffrey Engel, State Health
Director, the Pharmacy and Medical Boards passed an
emergency amendment to the pharmacist vaccination
rule in November 2009 authorizing pharmacists to
administer seasonal and H1N1 influenza vaccine to
patients age 14 and older.
This authority, however, expired in July 2010. Only a
permanent rulemaking proceeding could have extended
the authority.
The Medical Board again proved difficult to deal with on
this issue, and firmly opposed any permanent change.
North Carolina lags significantly behind many states on
this issue.
11. S.246
Adds vaccination authority to the
Pharmacy Practice Act
Would eliminate the need to get rulemaking
agreement from the Medical Board on this
issue.
Reorganizes the definition of “practice of
pharmacy” – no deletions, simply
reorganization (which, candidly, makes the
definition much easier to read).
12. S.246
Vaccinating Pharmacist qualifications:
provider level CPR training
certificate program in vaccine administration
three hours of vaccine-related CE every two
years
training in use of the Division of Public
Health’s vaccine registry.
13. S.246
Vaccination Authority
Minors, age 7 to 14, pursuant to prescription
order and with parental consent.
Minors, age 14 to 18, no prescription order
necessary, with parental consent
Adults 18 or over at patient’s request.
14. S.246
Recordkeeping/Reporting
Maintenance of all vaccines administered in
patient profile
Notify primary care provider (if identified by
patient) within 24 hours
Appropriate reports to vaccine registry with
24 hours
16. Drug Donation
S.L. 2009-423 creates N.C.G.S. § 90-85.44,
authorizing donation and redispensing of certain
drugs, supplies, and devices
Who can donate? Patient or patient’s family
member, manufacturer, wholesaler, pharmacy
Who can participate? Any licensed pharmacy.
Who can receive? Uninsured or underinsured
patient meeting criteria to be established by the
Board.
17. Drug Donation
What can be donated? Drugs, supplies, or a
medical device:
That is in the original, unopened, sealed, and tamper-
evident packaging or, if packaged in single-unit
doses, the single-unit dose packaging is unopened.
The pharmacist has determined that the drug,
supplies, or medical device is safe for redistribution.
The drug bears an expiration date that is later than
six months after the date that the drug was donated.
The drug, supplies, or medical device is not
adulterated or misbranded, as determined by a
pharmacist.
The drug, supplies, or medical device is prescribed by
a practitioner for use by an eligible patient and is
dispensed by a pharmacist.
18. Drug Donation Rulemaking
The Board has completed rulemaking (effective June 1,
2010)
Topics addressed by the rule:
Requirements for free clinics and pharmacies to accept and
dispense donated drugs, supplies, and medical devices pursuant
to the Program, including eligibility criteria, confidentiality of
donors, and standards and procedures for a free clinic or
pharmacy to accept and safely store and dispense donated
drugs, supplies, and medical devices.
The amount of the maximum handling fee that a free clinic or
pharmacy may charge for distributing or dispensing donated
drugs, supplies, or medical devices. (Note: resale of a donated
product is specifically prohibited)
Small categories of drugs whose donation is prohibited (e.g.,
controlled substances due to federal law) or restricted (e.g.,
certain injectables and biologicals can only be donated by
pharmacies, wholesalers, or manufacturers).
19. Drug Donation
Liability Protection – As long as drug is donated,
received, and dispensed in compliance with the
statute and rules, participating donors,
pharmacies, pharmacists, and practitioners are
“immune from civil liability for an act or omission
that causes injury to or the death of an
individual to whom the drug, supplies, or
medical device is dispensed under the Program,
and no disciplinary action may be taken against
a pharmacist or practitioner.”
21. Other Rulemaking Topics Floating
Around
Amendments to the patient counseling rules.
At the April 2010 meeting, Board members asked that
Board staff prepare a discussion draft of a “targeted”
mandatory counseling rule.
The Board has now indicated that it wants to see the
results of an ISMP study on this issue (due in Spring
2011) before taking any further action.
Remote order entry rule changes or additions.
No proposal on the table, but the issue keeps arising.
Clarity in delivery or “concierge” services.
New models of delivery service being proposed by
various pharmacies.
23. Board Election
The Northern and Western District seats are up
for election this spring.
Betty Dennis (Northern) and Rebecca Chater
(Western) will complete their second
consecutive five-year terms on May 1, 2012 and
are therefore ineligible for re-election.
Every pharmacist residing in North Carolina as of
March 15, 2010 is eligible to vote.
24. Candidates
Northern District
Beth Williams, Kernersville
Keith Waege, King
Carol Day, Carrboro
Western District
Bill Mixon, Hickory
Troy McNeill, Candler
Stephanie Kiser, Candler
Al Berg, Hendersonville
25. Procedure
Voting will again be electronic and will open in
mid-April.
Pharmacists may access candidate biographies,
photos, and an electronic ballot by logging in to
the Board’s website using license number and
PIN.
Paper ballots are available by request only. All
requests must be received at the Board office by
April 20, 2011.
Watch your email accounts and the Board’s
website for more information.
27. Effective Dates
Rulemaking began in June 2008.
Comment period closed September 2008.
DEA published the “interim final rule” on
March 24, 2010
Rule effective June 1, 2010
28. Pharmacy Conditions for Use
Pharmacies must use a system for
receiving CSERx that has been certified by
a DEA-approved auditor. Contact your
hardware/software vendors.
More information available here:
http://www.ncbop.org/faqs/Pharmacist/Co
ntrolledSubstanceE-RXFAQsApr2010.pdf
29. Bottom Line at this Point
Board staff has received many calls and e-mails from
pharmacies inquiring whether they may accept electronic
prescriptions for controlled substances under the DEA’s
new rule on the subject.
Unfortunately, the answer at this point remains “no.”
DEA’s rule requires that systems for sending and
receiving CSERx must be “certified” by a “third-party
auditor” as meeting the security requirements specified
in the rule.
DEA has stated that no such systems are certified yet;
moreover, DEA has not even designated any third-party
entities that it will allow to conduct audits and issue
certification.
30. Felony Controlled Substance
Convictions and Federal Law
Some pharmacists are unaware that the federal
controlled substances rules prohibit a registrant
(i.e., a pharmacy) from employing “any person
who has been convicted of a felony offense
relating to controlled substances” if that person
will have access to controlled substances. 21
CFR § 1301.76(a).
The would-be employing pharmacy must submit
a request to DEA to have this requirement
waived (and such waivers are rarely granted).
Pharmacist-managers need to exercise due
diligence in hiring to avoid violating this
regulation.
31. Technician Diversion
Continues to be a disproportionately heavy
component of Board investigations.
Pharmacist-managers are responsible for
the security of the pharmacy.
Appropriate oversight of technicians is
critical.
One source of diversion opportunity
commonly seen: complete delegation of
controlled substance ordering and
stocking to technicians.
32. Prescription Drug Shortages
Drug shortages continue to plague
patients and pharmacists.
Information about known drug shortages,
their cause, and anticipated resolution is
compiled by
FDA: http://www.fda.gov/Drugs/DrugSaf
ety/DrugShortages/ucm050792.htm
34. Background
The FD&C Act defines a “cosmetic” as “articles intended
to be rubbed, poured, sprinkled, or sprayed on,
introduced into, or otherwise applied to the human body
or any part thereof for cleansing, beautifying, promoting
attractiveness, or altering the appearance.”
The FD&C Act defines a “drug” as, among other things,
“articles intended for use in the diagnosis, cure
mitigation, treatment, or prevention of disease in man or
other animals” and “articles (other than food) intended
to affect the structure or any function of the body of
man or other animals.”
35. Who Regulates the Manufacturing
of Cosmetics?
The Food and Drug Administration.
No North Carolina agency directly
regulates the manufacturing of cosmetics.
If, however, the “cosmetics” were really
“drugs” (discussed shortly), both the Board of
Pharmacy and the Department of Agriculture
would have direct regulatory authority.
36. Is Cosmetic “Compounding”
Specifically Authorized by the
FD&C Act?
Section 510(g) of the FD&C Act states that
pharmacies do not have to register as
manufacturers if they “do not manufacture,
prepare, propagate, compound or process drugs
or devices for sale other than in the regular
course of their business . . . .”
Accordingly, any “making” of cosmetics is
manufacturing as that term is used in the FD&C
Act.
37. What Is Required of a Cosmetic
Manufacturer by FDA?
Cosmetics are not subject to pre-market
approval by the FDA (as are drugs).
Certain color additives used in cosmetics are,
however, subject to pre-market approval.
The manufacturing of cosmetics does not
require compliance with any specifically stated
Good Manufacturing Practices (GMPs). Drugs
are.
Manufacturers of cosmetics are not required to
register with FDA, though the FDA maintains a
Voluntary Cosmetic Registration Program.
38. What Is Required of a Cosmetic
Manufacturer by FDA?
Cosmetic products are subject to labeling requirements
under the FD&C Act and its regulations. Failure to
comply in all respects would be a misbranding violation
of the Act.
Labeling requirements are numerous and are
summarized in the FDA’s Cosmetic Labeling Guide:
http://www.fda.gov/Cosmetics/CosmeticLabelingLabelCla
ims/CosmeticLabelingManual/ucm126444.htm
Note that a cosmetic whose safety has not been
substantiated by studies must state on its labeling:
“Warning—The safety of this product has not been
determined.” Failure to include this warning is a
misbranding violation of the Act.
39. What Is Required of a Cosmetic
Manufacturer by FDA?
Because there are no cosmetic GMPs, failure to
comply with such does not lead to an
adulteration violation of the FD&C Act.
Nonetheless, a cosmetic can be deemed
adulterated under the FD&C Act on other
grounds. E.g., contains an injurious substance,
prepared under unsanitary conditions, contains
an unsafe color additive
40. When Does a Cosmetic Become a
Drug?
If the manufacturer of a cosmetic makes a “disease” or
“structure/function” claim about its product, it is a “drug”
under the FD&C Act.
Claims of this sort may be evidenced by:
Product labeling
Typical consumer use of the product, especially if that use is
based on an expectation created by the manufacturer
Inclusion of a substance in the cosmetic that is regulated as a
drug
United States v. Article . . . Consisting of 216 Cartoned
Bottles . . . “Sudden Change”, 409 F.2d 734 (2d Cir.
1969). A lotion derived from bovine serum albumin and
distilled water deemed a “drug” because of the
manufacturer’s claims that it would “lift out puffs” and
give a “facelift without surgery”
41. Consequences of a Cosmetic
Being Deemed a Drug
Absent pre-market approval of the product
as safe and effective for the labeled
indication, the product is adulterated and
misbranded.
Pharmacy would face severe civil liability
and likely criminal liability.
42. Other Considerations
General product liability laws will govern
the sale of cosmetics.
Will a pharmacy’s malpractice insurance
policy cover cosmetic manufacturing?
“Cozy” relationships with prescribers or
others who are making disease or
structure/function claims about the
cosmetic could lead to liability.
43. “The Safety of the People shall be the
Highest Law”
~~~Cicero
