Federal and State Pharmacy Law Update, May, 2015

Pharmacy Law Update
Jesse Vivian, RPh, JD
Department of Pharmacy Practice
2144 Applebaum
Direct Phone: 313-577-5389
Detroit Medical Center
April 14, 2015
Goals & Objectives
Provide current information on federal
and state statutes and regulations
pertaining to:
– Controlled Substances
Prescribing, dispensing, labeling, records
– Practice of Pharmacy
Technicians, community & institutional
– Compounding
Controlled Substances
Who can prescribe what from where
under what circumstances?
– Institutional Rules
– Community Rules
– Distinguish Policies, 3rd party
requirements from regulations
Validity of CS Scripts
– 90 days from date issued
– Note: No limit on number of days supply (Unless insurance
posts limits
3 scripts-30 days each with next fill date
No post-dating
– No refills (partial fill exceptions)
C-3 & 4
– 6 months from date issued
– Up to 5 refills
– 1 year from date issued
– No limit on refills (up to one year)
RPh Corresponding Responsibility
The Providers Dilemma:
Balancing Good Care and
Gatekeeper Duties
Policy Goal
Find way to Maximize Legitimate
Medical Use of Abusable Drugs
 minimal
intrusion on those with need
to access these drugs
While Minimizing Ability of
Abusers to Obtain These Drugs
 keep
the “bad guys” off drugs
“Corresponding Responsibility”
21 CFR § 1306.04: The purpose of a
To be effective, the CS Rx must be
issued for a legitimate medical
purpose by a practitioner acting in
the usual course of professional
The pharmacist has a “corresponding
responsibility” with the prescriber for
proper prescribing and dispensing.
An order purporting to be a
“prescription” is not a “prescription”
if not issued in the usual course of
professional treatment
The Pharmacists Manual
The dispensing pharmacist must
maintain a constant vigilance against
forged or altered prescriptions. The
law holds the pharmacist responsible
for knowingly dispensing a prescription
that was not issued in the usual course
of professional treatment.
The Pharmacists Manual
The quantity of drugs prescribed and
frequency of prescriptions filled are not
alone indications of fraud or improper
prescribing especially if the patient is being
treated with opioids for pain management.
Pharmacists should also recognize that drug
tolerance and physical dependence may
develop as a consequence of the patient’s
sustained use of opioid analgesics for the
legitimate treatment of chronic pain.
The Pharmacists Manual
The following criteria may indicate that a
prescription was not issued for a legitimate medical
 The prescriber writes significantly more prescriptions
(or in larger quantities) compared to other
practitioners in your area.
 The patient appears to be returning too frequently.
Prescription which should last for a month in legitimate
use, is being refilled on a biweekly, weekly or even a
daily basis.
 The prescriber writes prescriptions for antagonistic
drugs, such as depressants and stimulants, at the same
time. Drug abusers often request prescriptions for
"uppers and downers" at the same time.
 Patient appears presenting prescriptions written in the
names of other people.
 A number of people appear simultaneously, or within a
short time, all bearing similar prescriptions from the
same physician.
 Numerous "strangers," people who are not regular patrons or
residents of your community, suddenly show up with
prescriptions from the same physician.
The Pharmacists Manual
Characteristics of Forged Prescriptions
Prescription looks "too good"; the
prescriber’s handwriting is too legible;
Quantities, directions or dosages differ
from usual medical usage;
Prescription does not comply with the
acceptable standard abbreviations or
appear to be textbook presentations;
Prescription appears to be photocopied;
Directions written in full with no
Prescription written in different-color inks
or written in different handwriting.
Apparent erasure marks
Prevention Techniques
Know the prescriber and his/her signature;
Know the prescriber’s DEA registration number;
Know the patient;
Check the date on the prescription order. Has it been
presented to you in a reasonable length of time since the
prescriber wrote it?
When there is a question about any aspect of the prescription
order, call the prescriber for verification or clarification. Should
there be a discrepancy, the patient must have a plausible
reason before the prescription medication is dispensed.
Any time you are in doubt, require proper identification.
Although this procedure isn’t foolproof (identification papers
can also be stolen/forged), it does increase the drug abuser’s
If you believe that you have a forged, altered, or bogus
prescription--don’t dispense it--call your local police.
If you believe that you have discovered a pattern of
prescription abuses, contact your State Board of Pharmacy or
your local DEA office. Both DEA and state authorities consider
retail-level diversion a priority issue.
Health Care Providers’
Health Care:
taking care of patient needs to
maximize “outcomes”
recognizing CS Drugs have
therapeutic value, pain is a legitimate
disease and its treatment is necessary
and appropriate
“Gatekeeper” Function:
keep “bad” people from getting
“bad” drugs
Health and Human
Services Perspective:
U.S. is NOT aggressive in
pain control management.
Fear of patient addiction
and legal entanglement
prevents practitioners from
good pain control
HHS Policy Manual
February, 1992
Michigan CS Balancing Act
How to insure ‘good guys’ get the
CS drugs they need for legitimate
medical need,
But keep ‘bad guys’ from getting CS
drugs for ‘wrong’ reasons
The Good Faith
“Please Dear God,
let this prescription
be legitimate and
valid and I promise
to be your faithful
servant for the rest
of my life
Legislative Intent
The legislature finds that the treatment of pain is an appropriate issue for the
legislature to consider, and that the citizens of this state would be well served
by the enactment of legislation that accomplishes all of the following:
(a) Provides more and better information to health care consumers
regarding the medical treatment of pain, health care coverage and
benefits for the treatment of pain, and the education of health
professionals in pain and symptom management
(b) Provides for the appointment of an advisory body to study and
make recommendations on model core curricula on pain and
symptom management for the institutions in this state providing
health care education, continuing education for health professionals
on pain and symptom management, and the integration of pain and
symptom management into the customary practice of health care
(c) Educates health professionals about the disciplinary process for
state licensees and registrants, including, but not limited to, how
the department of [community health] processes allegations of
wrongdoing against licensees and registrants
Legislative Intent
(1) The legislature finds that the use of controlled substances is
appropriate in the medical treatment of certain forms of pain, and that
efforts to control diversion or improper administration of controlled
substances should not interfere with the legitimate, medically
recognized use of those controlled substances to relieve pain and
(2) The legislature finds that some patients in this state with pain are
unable to obtain from their health care providers sufficient pain relief
through the prescription of controlled substances, especially controlled
substances included in Schedule 2 under § 333.7214.
(3) It is the intent of the legislature to permit and facilitate adequate
treatment for pain by licensed health professionals, including, but not
limited to, the prescription or dispensing of controlled substances
included in Schedule 2 under section 7214, when medically appropriate,
and to enable regulatory and law enforcement agencies to prevent the
abuse and diversion of controlled substances by creating an electronic
monitoring system. [1] §16204c
Practitioners should avoid ‘knee-jerk’
response when confronted with treatment
of pain issues
– Fear of Legal Quagmire should not take
priority over good pain control and patient
care issues
– The key is BALANCE
The ‘standard of care’ is “Good Faith”
Statutory ‘Good Faith’
Sec. 7333
‘good faith’ means the prescribing or dispensing of
a controlled substance by a practitioner licensed
under section 7303 in the regular course of
professional treatment to or for an individual
who is under treatment by the practitioner for a
pathology or condition other than that
individual's physical or psychological
dependence upon or addiction to a controlled
substance, except as provided in this article.”
Cf: 21 CFR § 1306.04(a)
§ 7333
(2) a practitioner, in good faith, may dispense
a controlled substance included in schedule
2 upon receipt of a prescription of a
practitioner licensed under section 7303 on
a prescription form.
(4) A practitioner, in good faith, may dispense
a controlled substance included in schedule
3, 4, or 5 that is a prescription drug upon
receipt of a prescription on a prescription
form or an oral prescription of a practitioner.
Good Faith
Application of ‘good faith’ to a
pharmacist means the dispensing of a
controlled substance pursuant to a
prescriber's order which, in the
professional judgment of the
pharmacist, is lawful
‘Good Faith’ Standards
The pharmacist shall be guided by nationally accepted
professional standards including, but not limited to, all
of the following, in making the judgment:
(a) Lack of consistency in the doctor-patient
(b) Frequency of prescriptions for the same drug by 1
prescriber for larger numbers of patients.
(c) Quantities beyond those normally prescribed for the
same drug.
(d) Unusual dosages.
(e) Unusual geographic distances between patient,
pharmacist, and prescriber
Michigan Version of the Feds “Pharmacist Manual”
Changes to face of (all)
CS Scripts
With agreement of Prescriber, RPh
– patient's address, dosage form, drug
strength, drug quantity, directions for
use, or issue date
– Note changes on script or documentation
kept with script
NO Change to face of
CS Scripts
A pharmacist shall not change the
patient's name, controlled substance
prescribed (unless authorized to
dispense a lower cost, genericallyequivalent drug product) or the
prescriber's signature with regard to a
prescription. In addition, a pharmacist
shall not change the "do not fill until
Communication of CS
Script to Pharmacy
Hard Copy
Telephone (Not for C-2 unless
“emergency”—72 hour rule)
– Not Fax (1 exception)
FAX C-2 Scripts
For a resident of a long-term care (LTC) facility
may be transmitted by the practitioner or the practitioner's agent to the
dispensing pharmacy by facsimile, provided that the original manually
signed prescription (by the prescriber, not the "agent") is presented to
the pharmacist for review prior to the actual dispensing of the
The facsimile serves as the original written prescription.
LTC facilities need to have documented "agent of the prescriber"
arrangements with each nurse acting as a practitioner's agent.
Facilities should utilize the approved Drug Enforcement
Administration "agent of the prescriber" form for each nurse with
every prescriber and have these forms updated routinely per facility
Delegated CS Prescribing
MD & DO only allowed to delegate
PA, NP, Midwife Nurse
– “mid-level practitioners”
– Must have own DEA Registration
Name & DEA # of delegating Physician
must appear on script
– MD/DO not need to “co-sign”
PA CS Prescribing
Physician assistants (PAs) working
under delegated authority of an
allopathic physician (MD) and/or
osteopathic physician (DO) are
allowed to prescribe controlled
substance prescriptions, Schedules 25, without limitations to the quantity
or location of prescribing.
NP CS Prescribing
No limits on C-3 to C-5
Are limitations for the prescribing of Schedule 2
controlled substances
– for only those patients being discharged from the hospital
setting, free-standing surgical outpatient facility or hospice for a
quantity of no more than a seven-day supply.
– NPs cannot prescribe Schedule 2 controlled substances for their
ambulatory, every day patients.
SB 68 (March 16, 2015)
– Some Michigan nurses would be able to prescribe drugs without
a doctor’s consent.
– Address physician shortages in many rural areas of the state.
RPh Prescribing
There is nothing in the Public Health Code that prohibits a
pharmacist from prescribing a non-controlled substance under
delegated authority. A pharmacist would need to identify on a
prescription the name of the prescriber who granted them
delegated authority to prescribe.
A pharmacist, however, cannot prescribe controlled substances
since a pharmacist does not have authorization by the Public
Health Code or the Administrative Rules of the Boards of
Medicine or Osteopathic Medicine and Surgery nor are
pharmacists able to obtain a Drug Enforcement Administration
(DEA) registration number.
The Code of Federal Regulations prohibits a prescriber from
delegating the use of their DEA registration or their signature.
While pharmacists may be granted authority under delegation to
prescribe non-controlled substances, patients may have problems
filling these prescriptions under their prescription health
insurance coverage since many health plans do not recognize nor
credential pharmacist prescribers.
MAPS Reporting
The patient identifier
The name of the controlled substance dispensed
The metric quantity of the controlled substance dispensed
The National Drug Code (NDC) of the controlled substance
The date of issue of the prescription
The date of dispensing
The estimated days of supply of the controlled substance
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 Reporting
Patient Identifiers
Driver's license number,
State-issued identification number or
the number zero.
A social security number is no longer an allowable
In the case of a child or pet, all zeroes are
Not required for institutional patients
Tamper-Proof Prescriptions
Required for Medicare Part D eligible
– Both Rx-only and CS Scripts
In Michigan, no temper proof
hardcopy prescription forms required
CS Copy Transfers
Schedule 3-5 controlled substances may be
transferred once, if the pharmacies do not
electronically share them on a real-time
The transfer of controlled substance
prescriptions must be conducted between
two licensed pharmacists, whether done
verbally or electronically shared on a realtime basis.
CS Copy Transfers
Pharmacies that electronically share on
a real-time basis may transfer online
up to the maximum refills permitted
by law and the prescriber's
A Schedule 2 controlled substance
prescription may not be copied from
any pharmacy.
CS Copy Transfers
Responsibility of the transferring
– The pharmacist completing a transfer must write
the word "VOID" on the face of the invalidated
– On the back (reverse) of the invalidated
prescription, the pharmacist needs to document
the name, address and Drug Enforcement
Administration (DEA) registration number of the
pharmacy to which it was transferred to and the
name of the pharmacist receiving the
CS Copy Transfers
Responsibility of the receiving pharmacist:
– The pharmacist receiving the transfer must write
the word "TRANSFER" on the face of the
prescription and include all the required elements
of the controlled substance prescription in addition
to the date of issuance of the original prescription,
the original number of refills authorized, the
remaining number of refills and the date of original
– The pharmacist must also document the name of
the transferring pharmacy, address, DEA number,
the prescription number and the name of the
transferring pharmacist.
CS Scripts and Rx Techs
A practitioner or the practitioner's
agent may convey a prescription orally
to a pharmacist (or intern), who
promptly reduces to writing all
information required.
Techs NOT Allowed to take CS script
“Tech check Tech” in
In 1994, the Attorney General of the State of Michigan wrote
a memorandum to the Bureau of Occupational and
Professional Regulation (currently the Department of
Community Health) regarding allowing technicians to check
technicians and how it is in conflict with two statutes. Article
177 states in sections 17751(2) and 17763(a) and (b) that
drugs may only be dispensed by pharmacists and those
individuals specifically identified in Article 177. A pharmacist is
not permitted to delegate the act of dispensing except as
authorized in Article 177. However, section 16215 does
provide the Board of Pharmacy authority to promulgate rules
regarding delegation. Thus, according to the memorandum to
allow pharmacy technicians to dispense prescription drugs in
this manner, it would require the promulgation of
administrative rules. To date, no rules have been
E-Scripts for CS Drugs
Once the pharmacy's software has been certified to
accept electronically communicated controlled
substance prescriptions AND the prescribing physician's
electronic prescribing system has also been certified by
a Drug Enforcement Administration (DEA)-approved
However, until you receive documentation from your
software vendor that validates your system is compliant
with the new DEA regulations you cannot receive
prescriptions for controlled substances electronically,
even if the prescription is written by a prescriber whose
software system has been DEA certified.
Once a prescription is created electronically, all records
of the prescription must be retained electronically.
Electronic Signature
Electronically communicated prescriptions
are valid with electronic signatures for noncontrolled substances and for controlled
substances if the electronic prescriptions are
created and signed using an application that
has also been certified by a Drug
Enforcement Administration (DEA)-approved
The electronic signature can be a sound,
symbol or process attached to the record
(may or may not be a digital version of the
prescriber's signature).
Manual Signatures
A manual signature is required on all paper
prescriptions presented to the pharmacy or those
prescriptions transmitted from a physician's fax
machine to the pharmacy fax machine.
The prescriptions may be computer-generated;
– however, they must contain a manual or "wet" signature of
the prescriber if they are printed out.
– Electronically generated signatures on these paper or faxto-fax prescriptions are not valid.
The prescriber is required to sign a written
prescription in the same manner as (s)he would
sign a check or legal document.
Stamped Signatures are not valid
Okay to combine CS and Non-CS on single
blank (Rule 9b repealed 2014)
Electronically communicated prescriptions
are valid with electronic signatures for noncontrolled substances and for controlled
substances if the electronic prescriptions are
created and signed using an application that
has also been certified by a Drug
Enforcement Administration (DEA)-approved
Number of Scripts on
Single Hardcopy
Six medications per computergenerated prescription, and a
Four for a handwritten blank for noninstitutional pharmacy practice
CS and Non CS on Same
Prescription Hardcopy
Rule 9(b)(5) Repealed In 2014
Out of State Prescriptions
Non-CS Scripts
– Pharmacies can fill non-controlled prescriptions
written by prescribers (MDs, DOs, podiatrists,
physician assistants, nurse practitioners,
dentists, licensed veterinarians), outside of
Michigan (state, district, territory, commonwealth
or insular possession of the United States) as
long as they fall within the prescriber's scope of
– Pharmacists may also accept prescriptions for
non-controlled medications written by Canadian
MDs or DOs.
Out of State Prescriptions
CS Scripts
– Controlled substance prescriptions can only be
accepted if issued by a physician prescriber (MD
or DO) or dentist (DDS) prescriber who is
authorized under the laws of that state to
practice dentistry, medicine or osteopathic
medicine and surgery and is authorized to
prescribe controlled substances. and areas
subject to lawful authority of the U.S.
– Controlled substance prescriptions written by
mid-level practitioners (physician assistants,
nurse practitioners and certified nurse
Script Record-Keeping
Retain invoices, billing statements and Drug
Enforcement Administration 222 forms, etc., for two
Pharmacy prescription records for five years.
Michigan Medicaid requires records to be kept for
seven years
Medicare Part D regulations require all records to be
kept for 10 years.
Date of Last Refill
Return to Stock Meds
Community (outpatient)
– Once meds leave “control” of pharmacy, they cannot be
returned to stock
– If the pharmacy "returns to stock" in an open bottle of the
medication with the same lot number and expiration date
from which the drug was originally filled from, it is not
misbranding. If the lot number and expiration dates are
different, or it is left in the vial without an expiration date
or lot number, then it would be considered misbranding. It
would also violate the rule of ensuring the strength, purity
and quality of the medication dispensed.
– Unit Dose
Okay to return to stock
Destroying CS Meds in an
A responsible individual must record the destruction
of controlled substances in medical institutions.
Destruction usually occurs after a substance has
been dispensed and the patient expires or leaves
the institution.
The quantity destroyed and reason for destruction
must be recorded in a manner that achieves
accountability. Controlled Substance Rule 54(9)
If the institution has a policy that reflects current
practice standards and delineates the method of
destruction, an explanation would only be required
if policy is not followed.
Mailing Scripts
Law prohibiting Mail-Order Scripts was
repealed several years ago
If Mailing Meds through USPS, must
follow federal labeling rules
– Label container as required by Michigan
No “hazardous substances” may be
Vending Machines
Vending Machines
Must be approved by MI BoP
Pharmacy cannot own a Vending
Machine in a physician’s office
Many Types of Machines
– Dispensing in Pharmacy
– Administering Drugs to Patient
– Dispensing to Patient
Vending Machines
Crack pipe vending machines stir
controversy in western Canada
– An initiative by drug addiction outreach groups in Vancouver,
the brightly colored vending machines sell crack pipes for 25
cents, a move advocates say will curb the spread of HIV and
hepatitis. (2014)
Emergency Drug Boxes
– Each drug box under the control of the
pharmacy shall be examined at least weekly to
assure that the seal which designates that the
box has not been opened is still intact and the
expiration date has not been exceeded.
– If the expiration date has been exceeded or the
box has been opened, the box shall be returned
to the pharmacy.
– When written prescriptions are required, the
prescriptions of the attending physician or
hospice medical director shall accompany the
drug boxes that have been opened when the
drug boxes are returned to the pharmacy.
Emergency Drug Boxes
– 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
(g) The name and signature of the pharmacist who
received the box for restocking.
Emergency Drug Boxes
– Upon return of the drug box to the pharmacy,
the pharmacist shall reconcile the drugs
dispensed from the drug box with the
prescriptions of the attending physician or
medical director of the hospice. The pharmacist
shall note that the prescriptions were dispensed
from the hospice drug box on the back of the
– The prescriptions shall be filed in the same
manner as other prescriptions are maintained at
the pharmacy.
Compounding Drugs
New complex rules
What is compounding?
(Generic Definition)
The Art and Science of Creating
Personalized Medications
– Preparing personalized medications for
– Compounded medications are made
based on a practitioners prescription in
which individual ingredients are mixed
together in the exact strength and
dosage form required by the patient.
What is compounding?
(Michigan Legal Definition)
the preparation, mixing, assembling, packaging, and labeling of a drug or
device by a pharmacist under the following circumstances:
(a) Upon the receipt of a prescription for a specific patient.
(b) Upon the receipt of a medical or dental order from a prescriber or agent
for use in the treatment of patients within the course of the prescriber's
professional practice.
(c) In anticipation of the receipt of a prescription or medical or dental order
based on routine, regularly observed prescription or medical or dental order
(d) For the purpose of or incidental to research, teaching, or chemical analysis
and not for the purpose of sale or dispensing.
(4) "Compounding" does not include any of the following:
(a) Except as provided in section 17748c, the compounding of a drug product
that is essentially a copy of a commercially available product.
(b) The reconstitution, mixing, or other similar act that is performed pursuant
to the directions contained in approved labeling provided by the manufacturer
of a commercially available product.
(c) The compounding of allergenic extracts or biologic products.
"Compounding" does not
include any of the following:
(a) the compounding of a drug product that
is essentially a copy of a commercially
available product.
(b) The reconstitution, mixing, or other
similar act that is performed pursuant to the
directions contained in approved labeling
provided by the manufacturer of a
commercially available product.
(c) The compounding of allergenic extracts
or biologic products.
Federal Compounding Laws
The Drug Quality and Security Act
(DQSA) of 2013
– FDA released several policy documents
related to compounding as part of the
agency’s implementation of DQSA in
FDA Compounding Policies
Draft interim guidance describing FDA’s expectations for compliance
with current good manufacturing practice requirements for
compounding facilities registered as outsourcing facilities with FDA
A proposed rule that would revise FDA’s current list of drug products
that may not be compounded due to withdrawal from the market or
because they were found to be unsafe or ineffective
Final guidance for pharmacies and individuals that intend to
compound drugs under Section 503A, including FDA’s interim policies
and a non-exhaustive list of potential enforcement actions against
pharmacies or individuals that compound in violation of the Food,
Drug, and Cosmetic Act
Two Federal Register notices that reopen FDA’s request for
nominations for the bulk drug substances lists for compounding in
relation to Section 503A and Section 503B respectively
FDA Guidance Policy
“Pharmacy Compounding of Human
Drug Products Under Section 503A of
the Federal Food, Drug, and Cosmetic
Michigan Compounding Laws
Passed in 2014
Effective September 30, 2015
Two Classes
– Non-sterile
– Sterile
Sterile Compounders
A pharmacy that that provides
compounding services for sterile
pharmaceuticals must be accredited by
a national accrediting organization
approved by the board, and be in
compliance with USP standards in a
manner determined by the board.
Recordkeeping of Compounding
Except for distribution within a hospital or another health care entity
under common control, a pharmacist shall maintain a record of a
compounded sterile pharmaceutical in the same manner and for the
same retention period as prescribed in rules for other prescription
The pharmacist shall include, but is not limited to including, all of the
following information in the record required under this subsection:
(a) The name, strength, quantity, and dosage form of the compounded
(b) The formula to compound that includes mixing instructions, all
ingredients and their quantities, and any additional information
needed to prepare the compounded pharmaceutical.
(c) The prescription number or assigned internal identification number.
(d) The date of preparation.
(e) The manufacturer and lot number of each ingredient.
(f) The expiration or beyond-use date.
(g) The name of the person who prepared the compounded
(h) The name of the pharmacist who approved the compounded
More Compounding Rules
A pharmacist shall not offer excess
compounded pharmaceuticals to other
pharmacies for resale. A compounding
pharmacy shall not distribute samples or
complimentary starter doses of a
compounded pharmaceutical to a health
A compounding pharmacy may advertise or
otherwise promote the fact that they
provide compounding services.
Compounding Exception
Based on the existence of a health
professional/patient relationship and the
presentation of a valid prescription, or in
anticipation of the receipt of a prescription
based on routine, regularly observed
prescription patterns, a pharmacist may
compound for a patient a non-sterile or
sterile pharmaceutical that is not
commercially available in the marketplace
BoP Compounding Rules
to Come
The department (LARA), in consultation
with the board, may promulgate rules
regarding conditions and facilities for
the compounding of non-sterile and
sterile pharmaceuticals.