Pharmacy Law Review 2015
Eric Roath, Pharm.D.
Director of Professional Practice
Michigan Pharmacists Association
Learning Objectives
1. Identify general competencies used to prepare
for the Multistate Pharmacy Jurisprudence
Examination (MPJE);
2. Discuss how laws imposed by federal and state
governments, the Drug Enforcement Agency
(DEA), and state boards of pharmacy shape the
pharmacy regulatory environment; and
3. Explain the statutes and regulations impacting
the practice of pharmacy in the state of
Michigan.
MPJE Structure
• Computer Adaptive Test
– Can’t go back to prior questions
• 90 Questions
– 60 questions counted
What is on the MPJE
• Area 1 – Pharmacy Practice (84%)
• Area 2 – Licensure, Registration, Certification and
Operational Requirements (13%)
• Area 3 – Regulatory Structure and Terms (3%)
AREA 1.01 – PHARMACY PRACTICE
1.01.00 Identify the legal responsibilities of the pharmacist and other
pharmacy personnel.
•
•
•
•
The practice of pharmacy
Roles and responsibilities of pharmacy personnel
Pharmacy security, theft/loss procedures
Disposal and destruction of medications
What is Scope of Practice?
• Scope of practice is essentially the list (or
“scope”) of privileges that is granted to an
individual by a license
• All healthcare providers in the state of Michigan
have scope that is defined by their licensure
status
• In Michigan, being given a license by the bureau
of health professions = being a healthcare
provider.
Practice of Pharmacy
MCL 333.17707 (5) “Practice of pharmacy” means a health
service, the clinical application of which includes the
encouragement of safety and efficacy in the prescribing,
dispensing, administering, and use of drugs and related articles
for the prevention of illness, and the maintenance and
management of health. Professional functions associated with the
practice of pharmacy include:
(a) The interpretation and evaluation of the prescription.
(b) Drug product selection.
(c) The compounding, dispensing, safe storage, and
distribution of drugs and devices.
(d) The maintenance of legally required records.
(e) Advising the prescriber and the patient as required as
to contents, therapeutic action, utilization, and possible
adverse reactions or interactions of drugs.
Roles and Responsibilities
MCL 333.317707 (2) “Pharmacist” means an
individual licensed under this article to engage in
the practice of pharmacy.
(4) “Pharmacist intern” or “intern” means an
individual who satisfactorily completes the
requirements set forth in rules promulgated by the
board and is licensed by the board for the purpose
of obtaining instruction in the practice of
pharmacy from a preceptor approved by the board.
Roles and Responsibilities
MCL 333.317707 (3) “Pharmacist in charge” or “PIC” means
the pharmacist who is designated by a pharmacy,
manufacturer, or wholesale distributor as its pharmacist in
charge…
MCL 333.17748 (5) A pharmacist in charge shall supervise
the practice of pharmacy for the pharmacy in which he or
she has been designated the PIC. The duties of the PIC
include, but are not limited to, the following:
(a) Supervision of all activities of pharmacy employees as
they relate to the practice of pharmacy including the
purchasing, storage, compounding, repackaging, dispensing,
and distribution of drugs and devices to ensure that those
activities are performed in compliance with this part and the
rules promulgated under this part.
Roles and Responsibilities
MCL 333.17748 (5) (b) Enforcement and oversight of policies and
procedures applicable to the employees of the pharmacy for the
procurement, storage, compounding, and dispensing of drugs and
the communication of information to the patient in relation to
drug therapy.
(c) Establishment and supervision of the method and manner for
storage and safekeeping of pharmaceuticals, including
maintenance of security provisions to be used when the pharmacy
is closed.
(d) Establishment and supervision of the record-keeping system
for the purchase, sale, delivery, possession, storage, and
safekeeping of drugs and devices.
(e) Establishment of policies and procedures for individuals who
are delegated responsibilities for any of the tasks described in this
subsection by the PIC.
Roles and Responsibilities
MCL 333.17707 (6) “Pharmacy technician” means an
individual who is required to hold a health profession
subfield license under this part to serve as a pharmacy
technician.
MCL 333.17739 (1) An individual who performs any of
the following functions is considered to be serving as a
pharmacy technician and, except as otherwise
provided in this part, is required to be licensed under
this part as a pharmacy technician:
(a) Assisting in the dispensing process.
(b) Handling transfer of prescriptions, except
controlled substances prescriptions.
Roles and Responsibilities
MCL 333.17739. (1) (c) Compounding drugs.
(d) Preparing or mixing intravenous drugs for injection
into a human patient.
(e) Contacting prescribers concerning prescription drug
order clarification, which does not include drug
regimen review or clinical or therapeutic
interpretation.
(f) Receiving verbal orders for prescription drugs,
except orders for controlled substances.
(g) Subject to section 16215, performing any other
functions authorized under rules promulgated by the
department in consultation with the board.
Pharmacy Security Requirements
• Controlled Substances (21 CFR 1301.75):
– Kept in a locked “substantially constructed” cabinet
– Dispersed throughout the pharmacy (with noncontrols)
– Michigan law (R338.3143) is consistent with federal
law.
• Employment Controls (21 CFR 1301.76):
– Cannot employ someone with a felony conviction
related controlled substances OR someone denied a
DEA registration (with cause)
Theft/Loss of Prescription Drugs
• File a police report
• Any signs of a break in, physical entry or armed
robbery should be reported
• Controlled Substances (21 CFR 1301.76):
– Notify DEA Field Division Office within 1 business day for
“significant loss”
– Fill out DEA Form 106 (available online – within 10
business days) for any loss. (R 338.3141(3))
• “Significant Loss” – open to the judgement of a
registrant
– Quantity, Regular disappearance/patterns, what C.S. has
gone missing….
Disposal of Medications
• Legal for pharmacies to conduct medication take
back programs
• Medications are considered “diverted waste”
– NOT medical waste
• Pharmacies must register with the Department of
Environmental Quality as a producer medical waste
only if they administer vaccines or perform some
other task that generates medical waste.
• If a pharmacy is collecting used medications, they
must be kept in a separate area from other
inventory.
• Collection of C.S.’s requires an enhanced DEA
registration.
Disposal of Controlled Substances
21 CFR 1317.05 (a) Practitioner inventory. Any registered
practitioner in lawful possession of a controlled substance in its
inventory that desires to dispose of that substance shall do so in
one of the following ways:
(1) Promptly destroy that controlled substance in accordance
with subpart C of this part using an on-site method of
destruction;
(2) Promptly deliver that controlled substance to a reverse
distributor's registered location…
(3) For the purpose of return or recall, promptly deliver that
controlled substance … to: The registered person from whom
it was obtained, the registered manufacturer of the
substance, or another registrant authorized by the
manufacturer to accept returns or recalls on the
manufacturer's behalf; or
(4) Request assistance from the Special Agent in Charge of the
Administration in the area in which the practitioner is located.
Destruction of Controlled Substances
21 CFR 1317.05 (c) (iv) Practitioner methods of
destruction. Collectors that are practitioners (i.e.,
retail pharmacies and hospitals/clinics) shall dispose
of sealed inner liners and their contents… by
delivering sealed inner liners and their contents to
a distributor's registered location by common or
contract carrier pick-up or by distributor pick-up at
the collector's authorized collection location.
Medication Returns in an Institution
R 338.486 (7) A pharmacist shall personally supervise
the destruction of unused portions of prescription
medication, other than controlled substances under
part 71 of the code, dispensed to patients. However,
medications in single-unit packages and intravenous
solutions which are designed to be tamper-evident and
which show no evidence that tampering has occurred
may be returned to stock. Medications that leave the
medical institution or its legal affiliates may not be
returned to stock for redispensing.
AREA 1.02 – PHARMACY PRACTICE
1.02.00 Identify the requirements for the acquisition and distribution of
pharmaceutical products, including samples.
•
•
•
•
Maintenance of Prescriptions and Records
Customized Medication Packaging
Repackaging
Compounding
What Records Must Be Maintained?
• DEA Registration Certificate
• DEA 222-Forms (and Power of Attorney to sign)
– Controlled Substance Ordering System (CSOS)
– Digital certificate to sign a CSOS order
• Controlled substance receipts and invoices
• Controlled substance transfer, distribution or loss
forms including:
– DEA Form-106 (Theft/loss)
– DEA Form-41 (Surrender for Disposal)
– Records dispensed controlled substances
• Prescriptions/Prescription Records
• Inventories (initial and yearly)
• Signature Logs
Prescription Records
R 338.480 (1) A prescription shall be numbered, dated,
and initialed or electronically initialed by the
pharmacist who performs the final verification prior to
dispensing at the time of the first filling at the
pharmacy.
(2) If the drug that is dispensed is other than the brand
prescribed or if the prescription is written generically,
the name of the manufacturer or supplier of the drug
dispensed shall be indicated on the prescription.
(3) This rule does not apply to inpatient medical
institution service.
What is maintained in the record?
R 338.480a (4) A pharmacy may utilize a uniform
automated data processing system of recording refills if
the system is in compliance with all of the following
criteria:
(a) All information that is pertinent to a prescription
shall be entered on the record, including all of the
following information:
(i) The prescription number.
(ii) The patient’s name and address.
(iii) The prescriber’s name.
(iv) The prescriber’s federal drug enforcement
administration number, if appropriate.
What is maintained in the record?
R 338.480a (4) (a) (v) The number of refills authorized.
(vi) Whether the drug must be dispensed as written.
(vii) The name, strength, dosage form, and quantity of
the drug prescribed and the drug dispensed originally
and upon each refill. If the drug dispensed is other than
the brand prescribed or if the prescription is written
generically, then the name of the manufacturer or
supplier of the drug dispensed shall be indicated.
(viii) The date of issuance of the prescription.
(ix) The date and identifying designation of the
dispensing pharmacist for the original filling and for
each refill.
Document Retention Time Period
Document Type
All records for controlled substances
(inventories, acquisition records, etc.)
Schedule 2 Prescriptions
Schedule 3-5 Prescriptions
Non-controlled Prescriptions
Storage Requirement
2 years (Federal)
5 years (Michigan)
5 years (Michigan)
5 years (Michigan)
*** In Michigan, it is required that 3 separate files be maintained: one for
CII prescriptions, one for CIII-CV prescriptions, and one for all other
prescriptions
Note: This is commonly understood to mean retained from the last date of
fill, so effectively, most prescriptions must be retained for a total of 6 years.
Prescriptions filled under Medicare plans must be retained for as long as 10
years after service. This is a requirement for plan participants, however, not
a legal requirement.
Track & Trace (“Pedigree”)
• Product identification: Manufacturers and repackagers to
put a unique product identifier on certain prescription
drug packages, for example, using a bar code that can be
easily read electronically.
• Product tracing: Manufacturers, wholesaler drug
distributors, repackagers, and many dispensers (primarily
pharmacies) in the drug supply chain to provide
information about a drug and who handled it each time it
is sold in the U.S. market.
• Product verification: Manufacturers, wholesaler drug
distributors, repackagers, and many dispensers (primarily
pharmacies) to establish systems and processes to be able
to verify the product identifier on certain prescription
drug packages.
Track & Trace (“Pedigree”)
• Detection and response: Manufacturers, wholesaler drug
distributors, repackagers, and many dispensers (primarily
pharmacies) to quarantine and promptly investigate a drug that
has been identified as suspect, meaning that it may be
counterfeit, unapproved, or potentially dangerous.
• Notification: Manufacturers, wholesaler drug distributors,
repackagers, and many dispensers (primarily pharmacies) to
establish systems and processes to notify FDA and other
stakeholders if an illegitimate drug is found.
• Wholesaler licensing: Wholesale drug distributors to report
their licensing status and contact information to FDA. This
information will then be made available in a public database.
• Third-party logistics provider licensing: Third-party logistic
providers, those who provide storage and logistical operations
related to drug distribution, to obtain a state or federal license.
Repackaging
333.17766d(5)(c) “Repackage” means a process by
which the pharmacy prepares a unit dose package,
unit of issue package, or customized patient
medication package for immediate dispensing
pursuant to a current prescription.
Customized Patient Medication Packages
R 338.479c (1) “In place of dispensing 2 or more prescribed
drug products in separate containers, a pharmacist may, with
the consent of the patient, the patient’s caregiver, or a
prescriber, provide a customized patient medication package
(CPMP)…”
The package label must contain:
• Serial numbers for each prescription
• The name, strength, physical description, and total
quantity of each drug product
• The directions for use & cautionary statements
• The date of preparation & expiration date
• Name of the prescriber for each drug product
• Name address and telephone number of the dispenser
Compounding
• Compounding of pharmaceutical products by
pharmacies is permitted under FDA 503A
• Must be done by a licensed pharmacist or
dispensing physician (21 USC 353a) upon
– Receipt of a valid, patient-specific prescription order
– In anticipation of receipt of a prescription based upon
commonly observed prescribing patterns.
• Under new Michigan laws, pharmacies that
compound sterile products must be certified as
being compliant with USP <797>
Sales to Practitioners
• Also called dispensing for “office-use.”
• Pharmacies in Michigan may dispense FDA
approved products to prescribers to use in their
professional practice.
• Sales to practitioners cannot constitute >5% of
the pharmacy’s prescription volume (in dosage
units).
• Note: Compounding for office use is currently
prohibited federally unless a pharmacy is
registered as an Outsourcing facility under 503B
AREA 1.03 – PHARMACY PRACTICE
1.03.00 Identify the legal requirements that must be observed in the
issuance of a prescription/drug order.
•
•
•
•
Writing and transmitting prescriptions
Delegation
Controlled Substances
Modifying Prescriptions
Prescriptions
MCL 333.17708 (3) "Prescription" means an order by a
prescriber to fill, compound, or dispense a drug or
device written and signed; written or created in an
electronic format, signed, and transmitted by
facsimile; or transmitted electronically or by other
means of communication… Prescription includes, but is
not limited to, an order for a drug, not including a
controlled substance as defined in section 7104 except
under circumstances described in section 17763(e),
written and signed; written or created in an electronic
format, signed, and transmitted by facsimile; or
transmitted electronically or by other means of
communication by a… prescriber
Prescription Form
• MCL 333.7109 (5) “Prescription form” means a printed
form, that is authorized and intended for use by a
prescribing practitioner to prescribe controlled substances
or other prescription drugs …. and all of the following
requirements:
– Bears the preprinted, stamped, typed, or manually printed
name, address, and telephone number or pager number of
the prescribing practitioner.
– Includes the manually printed name of the patient, the
address of the patient, the prescribing practitioner’s
signature, and the prescribing practitioner’s drug
enforcement administration registration number.
– The quantity of the prescription drug prescribed, in both
written and numerical terms. (for controlled substances)
– Includes the date the prescription drug was prescribed.
What can be changed on a Rx?
• Upon verbal consultation with the prescriber, a
pharmacist may add or change:
•
•
•
•
•
•
A patient's address
Dosage form
Drug strength
Drug quantity
Directions for use
Issue date
• A pharmacist shall note the details of the
consultation and shall maintain that
documentation with the prescription.
What can’t be changed?
• Patient Name
• Prescriber Name
• Drug (Chemical Entity)
– NOTE: switches such as “Adderall” to “Adderall
XR” are considered changes in the chemical
entity, not the dosage form.
Mode of Transmission
• Written:
– “Hand written” prescription
– Can be prepared electronically, must be signed
manually
• Phone
– Transmitted by phone
• Facsimile
– Essentially a “written” prescription transmitted via fax
• Electronic
Electronic Prescription
• Legally in Michigan, this refers to prescriptions
transmitted:
– From Computer-to-Computer
– From Computer-to-Facsimile
• HOWEVER:
– Medicare policy (as well as those of some commercial
insurers) does not recognize computerized facsimile
prescriptions as valid.
Signature Requirements
Prescription Type
Written Prescription
Phone Prescriptions
Facsimile Prescriptions
Electronic Prescriptions
Signature Requirement
Manual or “Wet” signature
No signature necessary*
Manual or “Wet” signature
Electronic signature**
* Pharmacy personnel are responsible for properly identifying the
prescriber
** Prescriptions are only electronic if they REMAIN electronic. Once
a prescription is printed, it is now considered a written prescription.
Prescriptive Authority
MCL 333.17708 (2) "Prescriber" means a licensed
dentist, a licensed doctor of medicine, a licensed
doctor of osteopathic medicine and surgery, a licensed
doctor of podiatric medicine and surgery, a licensed
optometrist certified under part 174 to administer and
prescribe therapeutic pharmaceutical agents, a
licensed veterinarian, or another licensed health
professional acting under the delegation and using,
recording, or otherwise indicating the name of the
delegating licensed doctor of medicine or licensed
doctor of osteopathic medicine and surgery.
Who is a Prescriber?
•
•
•
•
•
•
•
Dentist
Doctor of medicine
Doctor of osteopathic medicine and surgery
Doctor of podiatric medicine and surgery
[Certified] Optometrist
Veterinarian
Another licensed health professional acting under
the delegation
– and using, recording, or otherwise indicating the name of
the delegating licensed doctor of medicine or licensed
doctor of osteopathic medicine and surgery.
Licenses
MCL 333.16106 (2) “License,” except as otherwise provided in
this subsection, means an authorization issued under this
article to practice where practice would otherwise be
unlawful... For purposes of the definition of “prescriber”
contained in section 17708(2) only, license includes an
authorization issued under the laws of another state, or the
country of Canada to practice in that state or in the country
of Canada, where practice would otherwise be unlawful, and
is limited to a licensed doctor of medicine, a licensed doctor
of osteopathic medicine and surgery, or another licensed
health professional acting under the delegation and using,
recording, or otherwise indicating the name of the delegating
licensed doctor of medicine or licensed doctor of osteopathic
medicine and surgery. License does not include a health
profession specialty field license.
Delegation
MCL 333.16104 (1) “Delegation” means an
authorization granted by a licensee to a licensed or
unlicensed individual to perform selected acts,
tasks, or functions that fall within the scope of
practice of the delegator and that are not within
the scope of practice of the delegate and that, in
the absence of the authorization, would constitute
illegal practice of a licensed profession.
The Rules of Delegation
• Prescribers writing prescriptions under
delegation MUST list:
– Their name
– Their DEA (if writing for a controlled substance)
– The name of the delegating prescriber
– Delegating prescriber’s DEA (controlled
substances)
– Their signature (wet or electronic)
Controlled Substance Schedules
Prescriptive Authority
Schedule
Physician
P.A.
N.P.
(Delegated) (Delegated)
Schedule I
VERY limited
No
No
Schedule II
Yes
Yes
Limited
Schedule III
Yes
Yes
Yes
Schedule IV
Yes
Yes
Yes
Schedule V
Yes
Yes
Yes
Legend (Unscheduled)
Yes
Yes
Yes
Classifications of Medications
Classification
Schedule II
Schedule III
Schedule IV
Schedule V
Legend Drugs
Over-the-Counter
Valid For
90 Days
6 Months
6 Months
1 Year
1 Year
1 Year
(If written as RX)
Refills Allowed
0
5
5
PRN
PRN
PRN
Issuing Multiple CII Prescriptions
Prescribers may issue multiple prescriptions
for the same CII medication under the
following conditions:
1. Up to 90 day supply
2. Legitimate medical purpose
3. Indicates earliest day may be filled
•
“Do not fill until..:”
Detoxification Programs
• Regulations for Methadone Treatment:
– R 325.14401 – 325.14423
• Methadone treatment and pharmacists:
– Cannot dispense methadone on an outpatient basis
unless working for a methadone treatment program
– Typically may only dispense methadone if being used
for pain
• Suboxone/subutex may be dispensed for
detoxification purposes
– Prescriber must have an X DEA number
Controlled Substances & Medicaid
For controlled substance prescriptions
written for Michigan Medicaid beneficiaries,
it is required that the prescription be issued
on a tamper-resistant (tamper evident)
prescription form.
AREA 1.04 – PHARMACY PRACTICE
1.04.00 Identify the procedures necessary to properly dispense a
pharmaceutical product, including controlled substances, pursuant to a
prescription/drug order
• Prescription Transfers
• Controlled Substance Situations
• Generic Substitution
• Labeling Requirements
• Adulteration & Misbranding
• Automated Dispensing Systems
• Centralized Prescription Processing
• Hospice Emergency Drug Box
Prescription Transfers
• Also called “Prescription Copies”
• A pharmacist or technician may transfer a prescription
between pharmacies
• Controlled substances may:
– Only be transferred by a pharmacist
– Only be transferred 1 time
• Using a real time data transfer to transmit between
pharmacies in the same company
Partial Fills and Controlled Substances
• A pharmacist may dispense partial fills for a
controlled substance in schedules 3-5 any number of
times as long as it is within the quantity limits
specified on the prescription and the prescription is
within its window of validity (i.e. not expired).
• Note: A partial fill does not constitute a refill.
• A partial fill for a controlled substance schedule 2
may be issued as long as the remainder of the
prescription is dispensed within 72 hours of the first
fill.
Transmitting C2s Via Fax
§1306.11 (a) … A paper prescription for a Schedule II controlled substance may be
transmitted by the practitioner or the practitioner's agent to a pharmacy via
facsimile equipment, provided that the original manually signed prescription is
presented to the pharmacist for review prior to the actual dispensing of the
controlled substance, except as noted in paragraph (e), (f), or (g) of this section.
(e) A prescription… for a Schedule II narcotic substance to be compounded for the
direct administration to a patient by parenteral, intravenous, intramuscular,
subcutaneous or intraspinal infusion may be transmitted by the practitioner or the
practitioner's agent to the pharmacy by facsimile. The facsimile serves as the
original written prescription…
(f) A prescription … for a Schedule II substance for a resident of a Long Term Care
Facility may be transmitted by the practitioner or the practitioner's agent to the
dispensing pharmacy by facsimile. The facsimile serves as the original written
prescription…
(g) A prescription … for a Schedule II narcotic substance for a patient enrolled in a
hospice care program certified and/or paid for by Medicare under Title XVIII or a
hospice program which is licensed by the state may be transmitted by the
practitioner or the practitioner's agent to the dispensing pharmacy by facsimile. The
practitioner or the practitioner's agent will note on the prescription that the patient
is a hospice patient. The facsimile serves as the original written prescription…
Emergency C2 Prescriptions
§1306.11 (d) In the case of an emergency situation… a pharmacist may
dispense a controlled substance listed in Schedule II upon receiving oral
authorization of a prescribing individual practitioner, provided that:
(1) The quantity prescribed and dispensed is limited to the amount adequate
to treat the patient during the emergency period…
(2) The prescription shall be immediately reduced to writing by the
pharmacist…
(3) If the prescribing individual practitioner is not known to the pharmacist, he
must make a reasonable effort to determine that the oral authorization came
from a registered individual practitioner, which may include a callback to the
prescribing individual practitioner using his phone number as listed in the
telephone directory and/or other good faith efforts to insure his identity; and
(4) Within 7 days after authorizing an emergency oral prescription, the
prescribing individual practitioner shall cause a written prescription for the
emergency quantity prescribed to be delivered to the dispensing pharmacist. …
the prescription shall have written on its face “Authorization for Emergency
Dispensing,” and the date of the oral order… Upon receipt, the dispensing
pharmacist must attach this paper prescription to the oral emergency
prescription that had earlier been reduced to writing…
Generic Substitution
333.17755 (1) When a pharmacist receives a prescription for
a brand name drug product, the pharmacist may, or when a
purchaser requests a lower cost generically equivalent drug
product, the pharmacist shall dispense a lower cost but not
higher cost generically equivalent drug product if available
in the pharmacy, except as provided in subsection (3). If a
drug is dispensed which is not the prescribed brand, the
purchaser shall be notified and the prescription label shall
indicate both the name of the brand prescribed and the
name of the brand dispensed and designate each
respectively. If the dispensed drug does not have a brand
name, the prescription label shall indicate the generic name
of the drug dispensed, except as otherwise provided in
section 17756.
Labeling Requirements
MCL 333.17756 (1) A prescription dispensed by a
pharmacist shall bear upon the label the name of the
medication in the container, unless the prescriber writes
“do not label” on the prescription. The prescription shall
also bear upon the label the following statement: “Discard
this medication 1 year after the date it is dispensed,”
unless the medication expires on another date under
applicable state or federal law or rules or regulations or
other state or federal standards. If the medication expires
on another date, the pharmacist dispensing the
prescription shall strike or omit the statement required
under this subsection and shall specify on the label the
actual expiration date of the medication.
Labeling Requirements (cont..)
R 338.486 (6) A pharmacy shall ensure that every medication
dispensed is identified with its name and strength labeled on the
container in which it is dispensed or on each single unit package. A
pharmacy that is engaged in drug distribution to medical institutions
which use unit-of-use packaging shall place identification on the
label of its package to allow the package to be readily traced. The
name of the patient, and or a unique identifier shall be labeled on
the medication container. The container may be the individual
patients' assigned medication drawer. The directions for use shall be
on the label of the container if the directions are not communicated
in another effective manner. If the medication is to be selfadministered, then directions for use shall be on the container. The
preceding provisions of this subrule are minimum labeling standards
only and do not supersede other applicable laws or rules.
Adulteration
• Any alteration that may effect the purity or quality of a
product
• Includes:
– Violation of packaging stability
– Contamination, Product appearance
– Variations in strength, quality or purity vs. official
compendium
– Violation of Current Good Manufacturing Practice (CGMP)
• MCL 333.1776 (2) A person shall not knowingly or
recklessly do either of the following:
– (a) Adulterate, misbrand, remove, or substitute a drug or
device knowing or intending that the drug or device shall be
used.
– (b) Sell, offer for sale, possess for sale, cause to be sold, or
manufacture for sale an adulterated or misbranded drug.
Misbranding
• Labeling or advertising is wrong/misleading
• Dispensing errors, among other things, are an
example of misbranding
• Applies to prescriptions as well as manufacture
label
• MCL 333.17762 –”manufacturer’s label states”
name & place of business of the manufacturer
Adulteration vs. Misbranding
• Misbranded if:
– Incorrect or misleading labeling, directions, or
advertising
• Adulterated if:
– Quality or strength impairments
– Purity impairments
– Manufacturing deficiencies
• Prescriptions can be both misbranded and
adulterated at the same time.
Automated Dispensing Cabinets
R 338.489(7) Policy and procedures for the use of the automated device
shall include a requirement for pharmacist review of the prescription or
medication order before system profiling or removal of any medication
from the system for immediate patient administration. This subrule does
not apply to the following situations:
(a) The system is being used as an after-hours cabinet for medication
dispensing in the absence of a pharmacist as provided in R
338.486(4)(i).
(b) The system is being used in place of an emergency kit as provided in
R 338.486(4)(c).
(c) The system is being accessed to remove medication required to
treat the emergent needs of a patient as provided in R 338.486(4)(c). A
sufficient quantity to meet the emergent needs of the patient may be
removed until a pharmacist is available to review the medication order.
(d) In each of the situations specified in subdivisions (a) to (c) of this
subrule, a pharmacist shall review the orders and authorize any
further dispensing within 48 hours.
(e) The device is located in a dispensing prescriber’s office.
Automated Dispensing Systems (ADS)
338.486(2) An automated device may be used only in the
following locations:
(a) A pharmacy.
(b) A hospital.
(c) A county medical care facility.
(d) A hospice.
(e) A nursing home.
(f) Other skilled nursing facility...
(g) An office of a dispensing prescriber.
(3) An automated device designed for the specific purpose of
selling, dispensing, or otherwise disposing of any drug or device
ordered by a prescription, as defined in the code, and located
within a licensed pharmacy shall be used only by a pharmacist, or
other pharmacy personnel under the personal charge of a
pharmacist.
ADS Machines
R 338.486(4) The pharmacist who directs the pharmacy
services shall develop, implement, supervise, and
coordinate all of the services provided, including, at a
minimum, all of the following:
(a) Dispensing medications in a form that minimizes
additional preparation before administration to the
patient, including the admixture of parenterals.
(b) Obtaining the prescriber's original medication
order, a direct carbonized copy, an electromechanical
facsimile, or other electronic order transmission.
Security measures shall be in place to ensure that
system access by unauthorized individuals is not
allowed
ADS as Emergency Kits
R 338.486(4) (c) Interpreting and reviewing the
prescriber's medication orders and communicating
problems with these orders to the physician or nurse
before administration of first doses. If the
interpretation and review will cause a medically
unacceptable delay, then a limited number of
medications may be stocked at the patient care areas
for the administration of first doses. These
medications shall be provided in a manner that ensures
security and immediate availability, such as sealed or
secured medication kits, carts, or treatment trays. A
pharmacist shall routinely inspect the medications and,
after use, shall verify the contents and replace the
medications as necessary.
After Hours Dispensing
338.486(4)(i) Providing a method by which medications can
be obtained during the absence of a pharmacist in a medical
institution where a pharmacist is not available 24 hours a
day… During the absence of a pharmacist, the services of a
pharmacist shall be available on an on-call basis. Only a
limited number of medications that are packaged in units of
use shall be available. The medications shall be approved and
reviewed periodically as deemed necessary, but not less than
once a year, by an appropriate interdisciplinary practitioner
committee of the medical institution…
The order and document shall be reviewed by the pharmacist
within 48 hours of removing medication from the cabinet or
its equivalent. The pharmacist who directs pharmacy services
in the medical institution shall designate the practitioners
who are permitted to remove the medication. A pharmacist
shall audit the storage
Centralized Prescription Processing
R 338.3051 (1) (a) “Centralized prescription processing
center” means a pharmacy operated under the
direction of a pharmacist that processes information
related to the practice of pharmacy and engages in
centralized prescription processing.
MCL 333.17753 (3) As used in this section, “centralized
prescription processing” means the processing by a
pharmacy of a request from another pharmacy to fill
or refill a prescription drug order or to perform
processing functions such as dispensing, performing
drug utilization review, completing claims adjudication,
obtaining refill authorizations, initiating therapeutic
interventions, and other functions related to the
practice of pharmacy.
Central Fill Pharmacies
• Must be licensed in the state of Michigan
• Share patient and drug information with the
delivering pharmacy
• Delivering pharmacist is responsible for
counseling
• Controlled substances must have “CENTRAL FILL”
on the face of the original prescription record.
Hospice Emergency Drug Box
R 338.500 (1) A pharmacy that establishes a medication box exchange
program for hospice emergency care services rendered in patients’
homes… shall establish drug boxes that are in compliance with this rule.
Before providing drug boxes for a hospice emergency care system, the
pharmacist in charge shall assure that the hospice has developed policies
and procedures that require all of the following:
(a) Maintenance by the hospice of a drug box exchange log that
accounts for the hospice’s receipt of the boxes from the pharmacy,
assignment of the boxes to registered nurses or physicians’ assistants,
and return of the boxes to the pharmacy for restocking.
(b) A procedure to assure that the drug boxes are inspected at least
weekly to determine if they have expired or have been opened.
(c) Procedures for the storage and control of a drug box while it is
assigned to, and being used by, a registered nurse or physician’s
assistant.
(d) A procedure for implementing the hospice medical director’s
responsibility for assuring that prescriptions for drugs removed from
the drug boxes are obtained from the attending physicians.
Hospice Emergency Drug Box
R 338.500 (5) A label that contains all of the following
information shall be attached to the drug box so that it
is visible from the outside of the box:
(a) The name and address of the pharmacy.
(b) The name and address of the hospice.
(c) The name of the pharmacist who last inspected
and restocked the drug box.
(d) The date the drug box was last restocked.
(e) The date on which the drug box must be
returned to the pharmacy for the replacement of
expired drugs.
(f) The number of the drug box.
Hospice Emergency Drug Box
R 338.500 (10) The pharmacy shall maintain a permanent
record of drug box exchanges on a drug box exchange log.
The record shall contain all of the following information:
(a) The number of the box.
(b) The name of the hospice to which the box is released.
(c) The date the box is released to the hospice.
(d) The name and signature of the pharmacist who
releases the box to the hospice.
(e) The expiration date assigned.
(f) The date the box is returned to the pharmacy for
restocking.
(g) The name and signature of the pharmacist who
received the box for restocking.
AREA 1.05 – PHARMACY PRACTICE
1.05.00 Identify the conditions for making an offer to counsel or
counseling appropriate patients, including the requirements for
documentation.
Counseling Requirements
• OBRA '90 also states to establish standards governing patient
counseling.
• Such discussions must include matters that are significant, (in the
professional judgment of the pharmacist) which include, but are not
limited to, the following:
–
–
–
–
–
name and description of the medication,
route of administration,
dose,
dosage form, and
duration of drug therapy.
• OBRA '90 also mandates pharmacists discuss
–
–
–
–
–
–
–
–
special directions and precautions for preparation of drugs,
administration and use by the patient;
common severe side effects or adverse effects
interactions and therapeutic contraindications
techniques for self-monitoring drug therapy;
proper storage;
refill information;
and appropriate action in case of a missed dose.
AREA 1.06 – PHARMACY PRACTICE
1.06.00 Identify the requirements for the distribution and/or dispensing
of nonprescription pharmaceutical products, including controlled
substances.
• Behind the counter products
• Schedule V exemptions
• NPLEX
“Behind the Counter” Drugs
• Emergency Contraceptives
– Plan B for women over 17 y/o
– Plan B One-step indicated for women over 15 y/o
• Pseudoephedrine
• OTC Schedule V
– Cough Syrups
– Anti-diarrheals
Ephedrine/PSE Containing Products
MCL 333.17766c (1) A person shall not do any of the
following:
(a) Purchase more than 3.6 grams of ephedrine or
pseudoephedrine alone or in a mixture within a single
calendar day.
(b) Purchase more than 9 grams of ephedrine or
pseudoephedrine alone or in a mixture within a 30-day
period.
(c) Possess more than 12 grams of ephedrine or
pseudoephedrine alone or in a mixture.
National Precursor Log Exchange (NPLEX)
• Pharmacy’s are required to maintain a log of
pseudoephedrine purchases, maintained for a
minimum of 6 months (R 333.17766e).
• NPLEX meets this requirement.
• Any purchase of pseudoephedrine from a
pharmacy must be reported to NPLEX within the
next business day (MCL 333.7340a)
Schedule V Exemption
• The following schedule V naroctics are considered to be
“exempt”
– Not more than 200 milligrams of codeine per 100 milliliters or
per 100 grams
– Not more than 100 milligrams of dihydrocodeine per 100
milliliters or per 100 grams
– Not more than 100 milligrams of ethylmorphine per 100
milliliters or per 100 grams
– Not more than 2.5 milligrams of diphenoxylate and not less
than 25 micrograms of atropine sulfate per dosage unit
– Not more than 100 milligrams of opium per 100 milliliters or
per 100 grams
– Not more than 0.5 milligram of difenoxin and not less than 25
micrograms of atropine sulfate per dosage unit
• Functionally, loperamide operates this way in MI.
AREA 1.07 – PHARMACY PRACTICE
1.07.00 Identify the proper procedures for keeping records of
information related to pharmacy practice, pharmaceutical products and
patients, including requirements for protecting patient confidentiality.
• Controlled Substance Inventories
• Michigan Automated Prescription System
• Health Insurance Portability and Accountability Act
Controlled Substance Inventories
R 333.7321 (2) Beginning May 1, 1989, and annually
thereafter, each person licensed under this article to
manufacture, distribute, prescribe, or dispense
controlled substances shall inventory and report to the
administrator all schedule 2 to 5 controlled substances
possessed by the person at the time of the inventory.
The annual report required under this subsection may
be conducted and submitted to the administrator not
more than 30 days before May 1, but shall be
conducted and submitted to the administrator not later
than 60 days after May 1. A person who violates this
subsection may be punished by a civil fine of not more
than $25,000.00 in a proceeding in the circuit court.
Michigan Automated Prescription
System (MAPS)
• Prescription Drug Monitoring Program (PDMP)
for Michigan
• Logs all controlled substances dispensed to
Michigan patients
• Many states, like New York, have already
implemented laws mandating MAPS screening
prior to writing a prescription – MICHIGAN IS
NOT ONE OF THESE
Data upload to MAPS
Report daily (electronically) or twice monthly (R 338.3162b)
• The patient identifier:
– Driver’s License or State ID
– If the patient is under 16 years of age, zeroes shall be entered as the identification
number.
– If the patient is an animal, positive identification of the animal’s owner
The name of the controlled substance dispensed.
The metric quantity of the controlled substance dispensed.
The NDC of the controlled substance dispensed.
The date of issue of the prescription.
The date of dispensing.
The estimated days of supply of the controlled substance dispensed.
The prescription number assigned by the dispenser.
The DEA registration number of the prescriber and the dispensing
pharmacy.
• The Michigan license number of the dispensing pharmacy.
•
•
•
•
•
•
•
•
MAPS Exemptions
• Medications administered directly to patients
• Dispensing of up to a 48 hour supply upon
discharge
• Controlled substance samples
• Veteran’s Affairs prescriptions
• Methadone treatment centers
HIPAA & Confidentiality
• HIPAA prohibits the dissemination of Personal
Health Information (PHI) to any parties:
– Without patient permission
– Not involved in the direct care of the patient
• All healthcare entities are bound by HIPAA
requirements, as well as companies contracted
with those entities.
• Requires a signed court order (or similar
documentation) to disclose any information
related to HIPAA.
AREA 2 – LICENSE & OPERATION REQ.
•
•
•
•
•
•
Licensure for facilities
Drug control licenses for dispensing practitioners
DEA registration validation
Renewal of pharmacist licenses
Out of state practices
Pharmacy space and signage requirements
Licensure for Facilities
MCL 333.20106 (1) "Health facility or agency", except as provided
in section 20115, means:
(a) An ambulance operation, aircraft transport operation,
nontransport prehospital life support operation, or medical
first response service.
(b) A clinical laboratory.
(c) A county medical care facility.
(d) A freestanding surgical outpatient facility.
(e) A health maintenance organization.
(f) A home for the aged.
(g) A hospital.
(h) A nursing home.
(i) A hospice.
(j) A hospice residence
Drug Control License
• MCL 333.17745 (1) Except as otherwise provided in this subsection, a
prescriber who wishes to dispense prescription drugs shall obtain
from the board a drug control license for each location in which the
storage and dispensing of prescription drugs occur. A drug control
license is not necessary if the dispensing occurs in the emergency
department, emergency room, or trauma center of a hospital
licensed under article 17 or if the dispensing involves only the
issuance of complimentary starter dose drugs.
• See MCL 333.17747 for additional details on the drug control license.
• Each physician prescribes under their personal DEA. No additional
DEA for the facility is needed.
• A prescriber only needs separate DEA numbers when practicing in
multiple states (as it is tied to their state license), or if they are
working with substance abuse detoxification. 21 USC 823:
https://www.law.cornell.edu/uscode/text/21/823
DEA Numbers and Verification
• Required for any practitioner prescribing,
dispensing or otherwise handling controlled
substances.
Source: http://www.pharmacy-tech-study.com/dea-number-verification.html
Renewal of Licenses
• Pharmacist Fees:
– Application Fee - $20.00 (initial)
– Pharmacist License - $30.00 (per year)
– Controlled Substance License - $85.00 (per year)
• CE requirements:
– 30 hours of CE total
• 10 hours of live CE
• 1 hour of pain & symptom management
Out of State Practices
• Any practice dispensing medications to patients
residing in MI at the time of delivery must be
licensed as a MI pharmacy
• If you are shipping to other states, you may be
subject to similar laws in those state (e.g. mailorder)
• Compounding pharmacies are subject to riskbased inspections from the MI Board… and they
are responsible for the costs
Housing of a Pharmacy
R 338.482 (1) All professional and technical equipment and
supplies and prescription drugs shall be housed in a suitable, welllighted and well-ventilated room or department with clean and
sanitary surroundings.
(2) All pharmacies shall have a prescription department which is
devoted primarily to the practice of pharmacy which occupies not
less than 150 square feet of space, and which includes a
prescription counter that provides not less than 10 square feet of
free working surface. For each additional pharmacist who is on
duty at any one time, the free working space shall be increased by
not less than 4 square feet. The prescription counter shall be kept
clean and orderly. The space behind the prescription counter shall
be sufficient to allow free movement within the area and shall be
free of obstructions.
Housing of a Pharmacy
R 338.482 (3) All pharmacies that occupy less than the
entire area of the premises owned, leased, used, or
controlled by the licensee shall be permanently
enclosed by partitions from the floor to the ceiling. All
partitions shall be of substantial construction and shall
be securely lockable so that drugs and devices that can
only be sold by a pharmacist are unobtainable during
the absence of the pharmacist. Identification of this
department by the use of the words "drug,”
“medicines," or "pharmacy" or by the use of a similar
term or combination of terms… shall be restricted to
the area that is licensed by the board. The pharmacy
department shall be locked when the pharmacist is
not in the on the premises
Signage Requirements
MCL 333.17757 (2) A pharmacist engaged in the business of selling drugs at retail
shall conspicuously display the [following] notice described in subsection (3) at
each counter over which prescription drugs are dispense:
• Under Michigan law, you have the right to find out the price of a prescription
drug before the pharmacist fills the prescription. You are under no obligation to
have the prescription filled here and may use this price information to shop
around at other pharmacies. You may request price information in person or by
telephone.
• Every pharmacy has the current selling prices of both generic and brand name
drugs dispensed by the pharmacy.
• Ask your pharmacist if a lower-cost generic drug is available to fill your
prescription. A generic drug contains the same medicine as a brand name drug
and is a suitable substitute in most instances.
• A generic drug may not be dispensed by your pharmacist if your doctor has
written "dispense as written" or the initials "d.a.w." on the prescription.
• If you have questions about the drugs that have been prescribed for you, ask
your doctor or pharmacist for more information.
• To avoid dangerous drug interactions, let your doctor and pharmacist know
about any other medications you are taking. This is especially important if you
have more than 1 doctor or have prescriptions filled at more than 1 pharmacy.
Pharmacist Supervision
The pharmacy must operate under the “personal charge” of a
pharmacist.
Personal charge means the immediate physical presence of a
pharmacist or dispensing prescriber.
MCL 333.16109 (2) “Supervision”… the overseeing of or participation
in the work of another individual by a health professional… in
circumstances where at least all of the following conditions exist:
(a) The continuous availability of direct communication in person or by
radio, telephone, or telecommunication between the supervised
individual and a licensed health professional.
(b) The availability of a licensed health professional on a regularly
scheduled basis to review the practice of the supervised individual, to
provide consultation to the supervised individual, to review records, and
to further educate the supervised individual in the performance of the
individual's functions.
(c) The provision by the licensed supervising health professional of
predetermined procedures and drug protocol.
AREA 3 – REGULATORY STRUCTURE
Overview of federal legislative action
Pure Food and Drug Act
• Enacted in 1906
• Prohibited selling adulterated and misbranded
drugs.
• No requirements for ingredients or approval
• Did not apply to medical devices or cosmetics
Food, Drug & Cosmetic Act
• Enacted in 1938
• Established the New Drug Application/Approval
Process (NDA)
• Required medications to have adequate
directions for use.
• Required labeling:
– Prescriptions
• Pharmacy Label
• Patient Information Label
– Manufactured Products
– Habit-forming drugs
Food, Drug & Cosmetic Act
• Grandfather Clause:
– Drugs marketed before 1938 were not subject to
review or NDA requirements
• No prescription-only stipulations
– “Safe only when used under medical supervision.”
• Did not necessarily require drugs to be effective
for intended use.
• Recognized USP-NF and Homeopathic
Pharmacopoeia of the US as official compendia.
Durham-Humphrey Act
• Amended the FDCA in 1951
• Created Prescription-Only and OTC Drugs
• Rx Only
– Indication “for prescription use only” must appear on
manufacturer labeling
• OTC
– Safe to use without medical supervision when
accompanied by adequate directions for use.
• Authorized verbal prescription orders and
permitted prescription refills.
Kefauver-Harris Act
• Amended the FDCA in 1962
• NOW drugs must be proven effective for
intended purposes
– Retro-active back to drugs approved between 1938
and 1962
– Drug Efficacy Study Implementation (DESI) for pre1962 drugs – [over 1000 products found to be
ineffective!]
• Required Informed Consent for Human Research
Subjects
• Implemented CGMPs
Poison Prevention Packaging Act
• Enacted in 1970
• Prevention of accidental poisoning of children
under age 5
• Requires “Hazardous Household Products”
(including MOST drugs) to be marketed in childresistant packaging.
• Patient or Physician may ask for non-childresistant packaging.
Poison Prevention Packaging Act
• Exemptions:
– Powdered unflavored aspirin
– Effervescent aspirin
– Sublingual nitroglycerin
– Oral contraceptives
– Hormone replacement therapy
– Powdered iron preparations
– Effervescent acetaminophen
– Hydrocarbon-containing products where the liquid
cannot flow freely
Federal Anti-Tampering Act
• Enacted in 1982
• Requires most oral OTC drug products (including
some dietary supplements) to have tamper-proof
indicators or barriers.
• Enacted after intentional cyanide contamination
of Tylenol in Chicago.
Medical Device Act
• Enacted in 1976
• Requires pre-market approval of medical devices
• Required implementation of:
– CGMP manufacturing standards
– Classification by intended use
– Record keeping and reporting requirements
Orphan Drug Act
• Enacted in 1983
• Provides incentives for manufacturers to produce
medications to treat rare diseases.
• “Rare diseases” effects <20,000 persons in the
United States.
Hatch-Waxman Act
• Amended FDCA in 1984
• Established standards for marketing generic drugs
• Abbreviated New Drug Application/Approval
(ANDA)
• 5 years of patent exclusivity to innovator products
(in general)
• Generic products must prove to be
therapeutically equivalent
• Established the FDA Orange Book
– Michigan is not an “Orange Book State”
Prescription Drug Marketing Act
• Enacted in 1987
• Prohibits re-importation of drugs that have left
the United States.
• Requires licensure of wholesalers under state
law.
• Bans the sale of drugs samples (complimentary
starter doses)
– Dispensed only at the behest of a physician
• Class of trade prohibitions keeping hospitals from
selling drugs to community pharmacies
Omnibus Budget Reconciliation Act
• OBRA ’90 – Enacted in 1990
• Requires “necessary and appropriate”
prospective drug utilization review
• Mandates offer to counsel
• Document it, or it didn’t happen…
FDA Modernization Act
• Amended FDCA in 1997
• Fast track NDA process for treatments for lifethreatening diseases
• Guidelines for pharmacy compounding
• Eliminated habit-forming warning labels (from
back in 1938)
• Mandated that drugs with pediatric indications
be tested in children
Biologic Price Competition
& Innovation Act
• Amended the FDCA in 2009
• Provided an abbreviated application pathway for
follow-on biologic (biosimilar) products
• Allows for substitution of biosimilar products that
the FDA deems as interchangeable at the point of
sale without intervention or notification of the
prescriber.
Drug Quality and Security Act
• Amended the FDCA in 2013
• Introduced by Rep. Upton (R, MI-6) in response to
New England Compounding Center incident.
• Created a new 503(B) classification for
compounding for office use
• Implemented “Track & Trace” provisions.
United States Pharmacopeia &
National Formulary (USP-NF)
• The official compendium of the United States
• If something is included in the official
compendium, it is considered a drug
• Also sets standards for dietary supplements and
food ingredients
• General chapters elaborate on compounding and
manufacturing standards (among other things)
Preparing for the MPJE
• Michigan Pharmacy Law: A Guide to the Statutes and
Regulations (7th edition)
– http://www.michiganpharmacists.org/onlinestore
• ASHP’s PharmPrep 4th edition, Federal Pharmacy Law
– http://www.ashp.org/pharmprep
• Reiss and Hall, Guide to Federal Pharmacy Law, 8th
edition
– http://apothecarypress.com/
• Links to free online resources:
– http://www.michiganpharmacists.org/resources/faqs
– http://www.michiganpharmacists.org/resources/guid
ance
http://legislature.mi.gov/
http://http://www.nabp.net/programs/examination/mpje/
Eric Roath, Pharm.D.
Director of Professional Practice
Michigan Pharmacists Association
Office: (517) 377-0224
Fax: (517) 484-4893
Eric@MichiganPharmacists.org