Law Review

Pharmacy Law Review
Practice of Pharmacy
Education Law: Article 137: 6801
The practice of the profession of pharmacy
is defined as the administering, preparing,
compounding, preserving, or the
dispensing of drugs, medicines and
therapeutic devices on the basis of
prescriptions or other legal authority, and
collaborative drug therapy management in
accordance with the provisions of section
sixty-eight hundred one-a of this article.
Pharmacy
Any place, other than a registered store, in
which drugs, prescriptions or poisons are
possessed for the purpose of compounding,
preserving, dispensing or retailing, or in
which drugs, prescriptions or poisons are
compounded, preserved, dispensed or
retailed, or in which such drugs,
prescriptions or poisons are by advertising
or otherwise offered for sale at retail.
5/22/2013
Note
The authors ofthis material prepared this
information to provide accurate information
regarding NYS pharmacy law effective t he date of
this presentation. The authors strongly
recommend the user refers to the original law
sources from where this information was taken
and use the following presentation as an adjunct
to those materials. The presentation is only a
summary and does not intend to cover the entire
scope of NYS pharmacy law.
Administer
"Administer", for the purpose of section sixty-eight hundr<!d one of
this article, means the direct application of an immunizing agent to
adults, whether by injection, ingestion or any other means, pursuant
t o:
patient specific ordu or specific rt:&imen prescribed or ordered by a
physici<tn or certified nurse practitioner, who hu 01 pr actice in tht> couuey in
which immuniution is .:utmil'listtri. for immuniutlons 10 prtovtnl innuenu
or nd medications quii'Hi for t merctncy ln-.umtnl of
councy- thr immunit.llhOil 10 be- .Miministt rtd hu
of sevtnryfiVt' thousa nd Ofltss. thrn t ht lictn)'cd physician or certified
nurse prctitiontr may bt in adjoming councy. Such shll
to immuniz.ing &tnts t o prtvtnt inftutn:u or pnturnoa.c-al .11nd
required for t mugency t rratmtnl of .l.naphyluis_ or
.11 pouitnt specific order pltscribed or by physicia n or nuT$r
for immut\iutions to hcrpu zoster.
DEFINITIONS
1
Definition of a Drug
Articles recognized in;
The official USP
Official Homeopathic Pharmacopeia of the US
Official National Formulary
Or any supplement to any of the above
Articles intended for use in the diagnosis,
cure, mitigation, treatment or prevention
of disease in man or other animals
Definition of Food
Articles used for food or drink for man or
other animals
Chewing gum
Articles used for components of any such
article
Label
A display of written, printed or pictorial matter upon the
immediate container of any drug, device or cosmetic. Any
requirement made by or under authority of this article
that any word, statement, or other information appear on
the label shall not be considered to be compiled with
unless such word, statement or other information also
appears on the outside container or wrapper, if there be
any, of t he retail package of such drug, device or cosmetic
or is easily legible through the outside container or
wrapper.
Immediate container does not include package liners.
5/22/2013
Definition of a Drug
Articles (other than food) intended to
effect the structure or function of the body
of man or other animals
Articles intended for use as a component of
articles in t he above clauses
Not including devices
Cosmetic
Articles intended to be rubbed, poured,
sprinkled or sprayed on, int roduced into or
otherwise applied to the human body for
cleansing, beautifying, promoting
attractiveness, or altering the appearance.
Articles intended for use as a component of
any such articles; except that the term shall
not include soap.
Labeli ng
All labels and other written, printed, or
pictorial matter
2
GENERAL LAWS, RULES, AND REGULATIONS
REGUlATORY STRUCTURE AND
TERMS
Food, Drug and Cosmetic Act of
1938
Resulted from 1937 sulfanilamide t ragedy
107 deaths caused by use of diethylene gyycol
(anti-freeze) in sulfanilamide elixir
Incident propelled passage of the 1938
FD&CAct
Drugs marketed prior to 1938 were
grandfathered
Durham-Humphrey Amendment of
1951
Amendment to the FDCA
Created two categories of drugs
Those t hat required medical supervision:
prescription or "legend" drugs
Those that did not require medical
supervision: "over-the-counter" or
nonprescription drugs
5/22/ 2013
Pure Food and Drug Act
Signed in 1906 by Congress
Prohibited foods and drugs that were
distributed through interstate commerce t o
be adulterated or misbranded
Did not require manufacturers to list
ingredients or directions
Did not regulate cosmetic products or medical
devices
Food, Drug and Cosmetic Act of
1938
Any new drugs must fi rst be proven safe
when used according to the directions
Requires labels include adequate directions
for use and warnings about habit forming
ingredients
Applies to cosmetic products and medical
devices as well as food and drugs
Durham-Humphrey Amendment of
1951
Required prescription drugs to include the
legend on manufacturer's label:
"Caution: Federal law prohibits dispensing
without a prescri ption" {now "Rx only")
Allowed for oral prescriptions to be
reduced to writing by the pharmacist
Prescriber able to authorize refills
3
Kefauver-Harris Amendment of
1962
Resulted from thalidomide tragedy of 1961
In the US, was experimentally used in 1960
FDA never gave final approval to the NDA.
Passed to ensure greater drug safety AND
effectiveness.
Medical Device Amendment of
1976
Classification of devices according to
specific function
Developed performance standards and pre-
market approval requirements
Manufacturers must conform with GMP
standards
Must record and report proper information
Waxman-Hatch Amendment
Drug Price Competition and Patent-Term
Restoration Act
Made the drug approval process more effective
for generic drugs: must demonstrate
"bioequivalence" to the FDA
Manufacturers of brand name products were
given special allowances as a result of going
through the FDA approval process.
5/ 22/2013
Kefauver-Harris Amendment of
1962
Required all new drugs to be proven safe
AND effective
FDA is responsible for prescription drug
advertising
Required informed consent for individuals
who were research subj ects and the
reporting of ADR's.
Creation of Good Manufacturing Practice
(GMP)
Orphan Drug Act of 1983
Orphan drug
Used to treat rare diseases
Tax and licensing incentives to
manufacturers
Made development of such drugs more
appealing (recover t he finances expended to
develop the drug)
Prescription Drug Marketing Act of
1987
Tighter restrictions on the distribution of
prescription samples and products
Banned the sale, trade, or purchase of drug samples
Specified precise record-keeping requirements for
drug samples (ie: storage)
Prohibited the resale of prescription drugs purchased
by hospitals or health care facilities (there were certain
exceptions to this rule)
4
FDA Modernization Act of 1997
One major goal was to reenact the 1992
Prescription Drug User Fee Act (PDUFA)
Major changes include:
Pediatric studies of drugs: manufacturers are given an
additional six months of marketing exclusivity if the
drug is accepted by the FDA
States regulate pharmaceutical compounding and
pharmacies are exempt from GMP standards and t he
need to submit new drug appli cations
Medicare Prescription Drug Improvement,
and Modernization Act of 2003
The federal government controls Medicar e
Provides seniors and individuals with
disabilities with a prescription drug benefit
Part D
Prescription drug program
Cost to patient is income-dependent
Medicare Part D
When a person enrolls, the premium and deductible are
"foxed" from January 1 till December 31 of that calendar year.
Co-Pays however may change if a drug is moved to a different
category.
A patient may change plans only once yearly, between
October 15 through December 7, unless a special situation
arises. Called Open Enrollment.
Medicare Advantage Disenrollment Period: During this time
you can leave a Medicare Advantage plan and switch to an
origi nal Medicare plan. Runs from january 1 through February
14.
s-Star Enrollment - A highly-rated insurance plan. Can switch
once per year from December 8 - November 30.
5/22/2013
FDA Moderni zation Act of 1997
Expediting study and approval of Fast track
drugs used to treat serious or life-threatening
conditions
Elimination of certain label requirements
"Caution: Federal law prohibits dispensing without
a "Rx only"
"Warning- May be habit forming" has been
eli minated
Medicare Part D
Patients who are not in a low-income
category pay a monthly premium and must
meet an annual deductible. After they meet
the deductible:
The plan will pay 75% of the annual drug costs until
the "coverage gap" is reached
During the "coverage gap", patient pays all drug costs
Following the "coverage gap", the plan resumes
coverage
Medicare Part D
"Any willing provider"- requires all prescription
benefit programs must participate with any
pharmacy agreeing to the terms and conditions of
the plan.
Patients will not be required to get their drugs
via mail-order and can receive greater than 30-
day supplies of chronic medications at a local
pharmacy
Vaccinations are now covered under Part D
(except influenza, pneumococcal, and hepatitis}
5
Medicare Part D
Contains a provision for MTM (Medication
Therapy Management)
Pharmacists are able t o receive payment from
Medicare if the patient is enrolled in Part D
Every benefit program sponsor must develop MTM
programs for patients enduring significant drug cost s
from a number of chronic conditions
MTM includes: medication reviews, anticoagulation
management, immunizations, etc.
Helpful Medicare website:
http://www. medicare.gov/
Poison Prevention Packaging Act -
1970
Intent of protecting children under 5 years
from accidental poisonings
Enforced by Consumer Product Safety
Commission
Requires use of child-resistant containers
for packaging most OTC's, prescription
drugs, and hazardous household products
Dispense only once in resistant containers or
vials
Medications Affected
Acetaminophen- package containing> 1 g
Diphenhydramine - containing >66 mg
Ibuprofen - containing .2: 1 g
Loperamide - containing> 0.045 mg
Mouthwash- containing .2:3 g of ethanol
Lidocaine - containing> 5 mg
Dibucaine- containing > 0.5 mg
Naproxen - containing .2: 250 mg
5/22/2013
Poison Prevention Packaging Act
REGULATORY STRUCTURE AND
TERMS
Aspirin
Methyl salicylate- liquid products
containing >5% by weight unless packaged
in pressurized spray containers
Controlled substances
Prescription drugs - oral dosage forms
Iron- all non-injectable drug products and
dietary supplements containing .2:_250 mg of
elemental iron per package
Ketoprofen - containing .2:50 mg
Fluoride - containing >50 mg of elemental
fluoride and o.s% fluoride
Minoxidil - containing >14 mg
Nonprescription products - any oral
product that contains any active ingredient
that was previously available by
prescription
6
Chil d Resistant Cont ainers
Designed to be significantly hard for
children <5 years to open but not difficult
for a normal adult to open
Exemptions
Prescr iber or patient requests
Request may be oral, but pharmacist should
document
Recommend patient sign waiver
Pat ient may make blanket request that all
medications be dispensed in noncompliant
packaging
Prescribers may not make such a request
Exceptions
Sublingual nitroglycerin
Subli ngual and chewable isosorbide dinitrate
products in strengths of s 10 mg
Sodium Fluoride products: liquid and tablet dosage
forms, containing not more t han somg of elemental
fluoride or nomg of sodium fluoride (NaF) per
package or not more than 0.5% elemental fluori de on
a w/w or w/ v basis.
Anhydrous cholestyramine in powder form
Mebendazole: 6oo mg per package
Betamethasone tablets: s 12.6 mg per package
5/22/2013
Other Provisions of the PPPA of 1970
All new and refilled prescriptions must be
dispensed with a child safety cap except:
The practitioner requests one not be
used
The patient requests not to have such a
device
The container is utilized in a hospital or
other facility where drugs are stored and
given by a health care professional.
Exempt ion - OTC
To facilitate access of products t o elderly
and handicapped patients
Manufacturer is allowed to market one si ze of
a product in noncompliant packaging
Must contain "This package is for households
without young children ."
Excepti ons
Potassium supplements in unit dose forms: 5 50 mEq per
dose
Erythromycin echylsuccinace granules for oral suspension:
58 g of erythromycin
Colestipol powder: 55 g in packet
Erythromycin echylsuccinace tablets: 96 g of
erythromycin per package
Preparations in aerosol containers intended for inhalation
t herapy
Aspirin and APAP effervescent tablets or granules
containing 515% of either drug
Sacrosidase in a solution of glycerol and water
7
Exceptions
Pancrelipase preparations (tablet, capsule, powder forms)
Prednisone tablets: ~ 1 0 5 mg per package
Methylprednisolone tablets: ~ 8 4 mg per package
Oral contraceptives: administered in manufacturer's
mnemonic dispenser
Hormone replacement products- rely solely on the
activity of one or more progestogens or estrogens
Drug Approval Process
TERMS
Investigational New Drug
Application
First application form a sponsor must
submit to the FDA before administration to
humans
Protects the rights and safety of human test
subjects
Include proof of preclinical testing on animals
FDA has 30 days to decide whether the
investigational drug is suitable for t esting
5/ 22/2013
Anti-Tampering Act of 1982
Requires tamper evident packaging be used
for select OTC products and cosmetics
Product has an indicator or barrier to entry
If the seal is broken, some visible evidence of
entry will be evident
Product label must state t hat it is a tamper-
evident package and how to know if the
package has been tampered with
New Drug
Drug not recognized among experts as safe
and effect ive for use under the conditions
recommended in the drug's labeling
Cl inical Trials - Phase I
Small group of healthy patients
Ultimate goal is to evaluate toxicological,
pharmacological and pharmacokinetic
data, as well as assess safety in humans
8
Clinical Trials- Phase II
Larger group of patients ( ~ 1 0 0 ) that have
the disease or symptoms
Primarily concerned with determining
usefulness in preventing or treating the
disease
Treatment Investigational New
Drugs
Allows the administration of an
investigational new drug in those patients
who are not enrolled in the drug's clinical
trial
Patients are at a life-threatening stage of their
illness to which there is presently no cure or
drugs approved to treat the condition have not
been effective
Clinical Trials - Phase IV
Occurs after drug product is marketed
Obtain additional data of drug's safety and
effectiveness
Determine new uses or abuses
Healthcare professionals are encouraged to
report any problems experienced with the
drug's use (adverse effects)
FDA can withdraw drug based on data
collected
5/ 22/2013
Clinical Trials- Phase Ill
Large group of patients, usually in a clinical
setting
Provides additional evidence of the
effectiveness and more information on
adverse reactions
Provides additional information on
optimum dosing
New Drug Application
Request for approval for marketing
Once approved, manufacturer may market
product
Complet e evaluation of safety and efficacy
FDA generally reviews NDA for at least 180
days and allows interested individuals to
view and comment on the application
Fast Track Approval
Approved by the Secretary of HHS
Allows for the expedited approval of a
potential new drug if that product is:
intended to treat a serious oflife threatening
condition AND
addresses an unmet medical need
Approval also conditioned on post-
marketing studies to verify and describe
the drug's benefit
9
Abbreviated New Drug Application
Requires less data than NDA but it does
require proof that the new drug's
pharmacokinetic properties, bioavailability
and clinical activity is similar to the
original developer's product
FDA Classification for New Drugs
Type P (priority)
No other effective drugs available
Possess significant advantage compared to
currently marketed drugs
Type S (standard)
Similar to other drugs on the market
Further Classification
TypeAA
Drug with potential
use for AIDS or HIV
related disease
Type E
Type F
Drug that has been
placed on hold until
submitted data has
been further validated
Drug for a life- Type N
threatening or severely Drug being considered
debilitating disease for OTC status
Type V
Drug being considered
for "orphan drug"
status
5/22/2013
Supplemental New Drug
Application
Applies to manufacturers who originally
filed an NDA
Utilized to adopt changes for an existing
drug product ranging from production to
labeling
Eliminates the need to file a new NDA
Chemical Classification
Type1
New molecular
structure
Type 2
New derivative of a
molecular structure
already approved in US
Type 3
New formulation of a
drug already marketed
in US
Type 4
New combination of
two or more drugs
Type 5
Drug is being
manufactured by a new
company
Type 6
New therapeutic
indication for a drug
already approved
CONSIDERATIONS FOR
MARKETED DRUG PRODUCTS
10
Good Manufacturing Practice
Set of regulations that establishes
minimum standards required to
manufacture pharmaceutical products in
the United States.
Designed to assure safety and quality of
pharmaceuticals
Compliance is the responsibility of the
manufacturer.
National Drug Code
XXXXX-XXXX-XX
First 5 numbers represent the manufacturer
Remaining numbers represent the specific
drug lD and package !D.
Adulteration
Contains in whole or in part any filthy, putrid or
decomposed substance
Prepared, packaged or held under insanitary
conditions
Unapproved color additives
If it is a drug, and any or all of its container is
composed of a poisonous or deleterious
substance that may be injurious to health
Manufactured under conditions that do not meet
GMP standards
5/22/2013
National Drug Code
All drug products marketed in the US must
have an NDC number
Most companies include the NDC number
on their labeling
Consists of typically 10 characters
Aids in identifying drug product
Used for reimbursement purposes by third
party payers
Adulteration vs. Misbranding
Adulteration
Refers to the product make-up
Misbranding
Refers to the product labeling
Adulteration
Contains a drug recognized in the official compendia but
its strength. purity, or quality is lower than the official
standards
Contains any ingredient as a substitute for the active drug
I fit is a drug AND any substance has been mixed or
packed to reduce quality or strength OR substituted
wholly or in part therefor.
Sold under OR by a name not recognized in the USP or
NF but is found in a standard work on pharmacology
recognized by the board, BUT differs in strength, quality,
or purity as described in that standard work.
11
Misbranding
Labeling is false or misleading
Labeling is missing either name or location
of manufacturer / distributor
Label does not contain a word, statement,
or other information required by law
displayed in a prominent, readable manner
Label does not include the established
name of t he active drug
Misbranding
Label has inadequate directions for use for
nonprescription drugs or does not include appropriate
warni ngs required to protect those using the medication
or packaging
Label is not in accordance with USP/NF specifications
Label offers the sale of the drug under the name of
another drug
Failure to package drug according to Poison Prevention
Packaging Act
Does not possess t he statement, ''Warning-May be habit
forming" on narcotic or hypnotic substances
Manufacturer Drug Label
Name and address of
manufacturer / packer I distributor
Established name of drug
Net quantity
Weight of each active ingredient contained
in each dosage unit
Federal legend - "Rx Only"
5/ 22/2013
Misbranding
Label does not have each active ingredient
identified
Label does not stat e "Rx only" if a
prescription drug
Label does not contain a precautionary
statement concerning a drug subject to
deterioration
Label is missing quantity of container's
content
Product Labeling
The term "label" refers to written, printed,
or graphic matter appearing on the
immediate container of a drug product
If there is an outside package, any word,
statement, or other information present on the
inner container must also appear on the
outside package
"Labeling" refers to the above, as well as
any accompanying written, printed or
graphic matter (i.e. patient package insert)
Manufacturer Drug Label
If not taken oraUy, the specific route of
administration
Special storage directions if applicable
Manufacturer's control or lot number
Expiration date established by
manufacturer
Statement direct ed to pharmacist
specifying type of container to be used in
dispensing
12
Special Label Warnings
FD&C Yellow No.5
( tartrazine)
Aspartame
Sulfites
Mineral oil
Wintergreen Oil
Sodium Phosphates
Isoproterenol
inhalation products
Ipecac syrup
Phenacetin
Salicylates (including
aspirin)
Alcohol warning
Package Insert
Description (chemical structure, solubility,
etc.)
Clinical pharmacology
Indications, usage
Warnings, precautions and
contraindications
Adverse reactions
Patient Package Inserts
Regulation requiring information to be
provided to patient concerning a
medication's
Use
Potential Risks
Provided as a leaflet written in lay language
Considered part of FDA-regulated product
labeling
5/ 22/2013
Package Insert
Manufacturer required to provide in
prescription drug packages
Information contained within insert must
be approved by the FDA
For informational purposes only
Package Insert
Drug abuse and dependence
Symptoms and treatment of overdose
Recommended dosage and administration
Available dosage forms
Most recent label revision date
Patient Package Inserts
Applies to all physicians, community
pharmacists, and hospital pharmacists who
dispense
In acute care hospitals, regulation exempts the
provision of a PPI each time the drug is
dispensed
PPI must be provided prior to the
administration of the first dose and every 30
days thereafter
13
Medication Guides
Manufacturers provide Medication Guides
for certain prescription drugs that pose a
serious and significant public health
concern
Must obtain FDA approval of the Med Guide
and supply sufficient copies to pharmacies
Applies to both new and refill prescriptions
Pregnancy Warnings
Category A
Have been adequate, well controlled studies in
pregnant women that demonstrate no risk to
the fetus during all trimesters of pregnancy
Category B
Adequate, well controlled studies have not
been conducted in pregnant women. Animal
reproductive studies have failed to
demonstrate fetal risk.
Pregnancy Warnings
CategoryX
Contraindicated in pregnant women
Studies in animals or reports in pregnant
women, indicate that the risk of damage
caused by the drug clearly outweighs any
possible benefit
5/22/2013
Medication Guides
FDA requires MedGuides when:
Patient labeling could prevent serious adverse
effect s
The product has serious risks relative to
benefits
Patient adherence to di rections is crucial
Prescriber may request a MedGuide not be
provided to a particular patient
Pregnancy Warnings
Category C
Safety of the drug during human pregnancy
has not been determined. Animal studies are
either positive for fetal risk or have not been
conducted.
Category D
Positive evidence of risk to human fetus mainly
based upon adverse reaction data
Unit Dose Packaging and labeling
Information to be included on each unit-
dose package:
Generic name and trade name, if applicabl(
Quantity of active drug
If more than one, t he number of dosing units.
Name and place ofbusiness of manufacturer/packer/ distributor
Lot or control number
Expiration date
'"Warni ng: May be habit forming"' if applicable, the proper
controlled substance symbol , in addition to any required info.
Other appropriate information if needed (ie: for a recognized drug
"protect !Tom light, etc.
14
Bar-Coding
FDA requires pharmaceutical companies to
bar code all drug products supplied to
hospitals (however hospitals are not
required to utilize them)
Prescription, biologicals, nonprescription
Single-unit containers used for unit-dosing
Not physician samples
Bar code must contain product's NDC
Considered to be part of product label
Subject to GMP
MedWatch Program
Enhances the effectiveness of post-
marketing surveillance
Quickly identifies major health concerns
Increase awareness of drug-and device-
induced disease
Clarify what should be reported
Make it easier to report problems
Provide regular feedback to the healthcare
community
Drug Recalls
Class I
May cause serious adverse health consequences,
including death
Includes stock in pharmacies and notification of
patients
Class II
May cause temporary or reversible effects
Usually includes stocks in pharmacies
Class IIJ
Unli kely to cause any adverse health consequence
5/22/2013
REPORTING INITIATIVES
VAERS
Co-sponsored by CDC and FDA
Vaccine Adverse Event Reporting System
Surveillance system to report any event
concerning the administration of vaccines
licensed for use in the US.
Compounding vs. Manufacturing
Due to the increasing number of drug
products compounded by manufacturers,
less compounding is performed in
pharmacies.
The main question is "When does
prescription compounding become
manufacturing?"
Refer to the FDA Compliance Policy Guide
of 1992 to address this issue
15
Compounding vs. Manufacturing
The quantity prepared is reasonable for filling either
existing prescriptions or anticipated orders based on
prescribing habits of local prescribers.
Dosage forms compounded are not being provided or sold
to other pharmacies or third parties.
What is compounded is not currently available from a
manufacturer/supplier
A pharmacy can say they specialize in prescription
compounding but CANNOT specify a specific product
The pharmacy must limit its interstate distribution of
compounded products to not more than s% of its total
prescription volume.
Repacking
Can be done by a pharmacist, or an
unlicensed person under t he supervision of
a registered pharmacist.
Labels on repacked drugs shall bear
sufficient info for proper ID and safety.
Specific records must be maintained.
Records must be maintained for 5 years
and must be readily available
NYS Organizational Structure
TERMS
5/22/2013
Expirations for Compounds
Always use stability information available
If no informat ion is available:
For nonaqueous liquids and solids - not more
t han 25% of the time remaining on the
commercial product or a max of6 months
whichever is less
Aqueous solutions made from solids - 14 days
when stored at a cold temperature
All others: the duration of therapy, not more
than 3o days
Repacking
Record keeping incl udes:
Namto strencth ofthto drug
N.amto oftht' moulufacturtor .a nd distributor (if difff renl)
Manufacture-r lot numbe r
Quantiry of each comaiMr
Numberofunits
Oatt
dating
of person ptorfo rmin& the re.packing
Slaru.rure oft he ph<lnno11dsr i1.1pervisine (ht
Any other intei'NII marken: ne-cessary
Drugs repacked for use only an expiration date of 12
months or 50% of the tlme remaining on the manufacturer's
expiration date, whichever is less.
Board of Regents
Education l aw: Article 130 Subarticle 2: 6506
The University of t he State of New York
A citizen body responsible for education at
all levels, in charge of education, licensing
and discipline of the professions
Provides for boards to advise the regents
and t he Commissioner of Education on all
matters relating to licensure and discipline
16
State Education Department
Education Law: Article 130 Sub article 2: 6507
Administers the admission to and practice
of the professions
Establish standards for pre-professional
and professional education, experience and
licensing examinations
Register or approve education programs
Issue licenses, registrations, and limited
permits to qualified applicants
State Board of Pharmacy
Board composed of
not less than 9 pharmacists licensed in the
state for at least 5 years AND
at least 2 public representatives
Executive Secretary
Appoint ed by the regents on recommendation
of the commissioner
Licensed in state for at least 5 years
To Practice
Educati on Law: Article 130 Subarticle 1: 6502
A license is valid during life of the holder
unless revoked, annulled or suspended by
the board of regents
Must register with education department
t o practice
5/22/2013
State Boards
Education Law: Articl e 130 Sub articl e 2: 6508
Appoint ed by t he Board of Regents
Assist the board of regents and stat e education
department on matters of professional licensing,
practice and conduct
Prepare examinations and assist the department
in other licensing matters as prescribed by the
board of regents
Conduct disciplinary proceedings and assist in
other professional conduct matters
Review applications for licensure
State Board of Pharmacy
Education Law: Articl e 137: 6804
Regulate the practice of pharmacy and the employment of
interns and employees in pharmacies,
Regulate and control the sale, distribution, character and
standard of drugs, poisons, cosmetics, devices and new
drugs,
Employ inspectors and chemists,
Prevent the sale or distri bution of such drugs, poisons,
cosmetics, devices and new drugs as do not conform to
the provisions of this article or of t he public healt h law,
Investigate alleged violations
Issue limited permits or registrations.
Change of Information
Education Law: Art icle 130 Subarticle 1: 6502
Address or Name change
Education law requires notification within 30
days
17
Continuing Educat ion
Educati on Law: Art icl e 137: 6827
Regulations of the Commissioner: Part 63: Pharmacy: 63.7
Must register triennially and comply with
continuing education requirements
Complete a minimum of 45 hours
No more than 22 hours shall consist of self-
study courses
At least 3 hours must be related to medication
errors
Recent graduates no longer exempt!
Exempt only if not engaged in practice
Continuing Education
Collaborative Drug Therapy Management
At least 5 hours of formal continuing education
acceptable to the department in the area or areas of
practice generally related to any collaborative drug
therapy management protocols to which the
pharmacist may be subj ect
Continuing Education -
Record keeping
Must record the following information for
each course taken:
Title
Number of hours
Sponsor's name
Verification
Date and location
Must be maintained for 6 years from the
date completed
5/22/2013
"acceptable formal conti nuing education" - formal courses of
learmng which contribute to professional practice in pharmacy
and wh1ch meet the standards prescribed by regulati ons of the
commissioner
Techniques to reduce medication and prescripdoo errors
Pharmacology of new and developing drugs; drug interactions
Public health issues
Infection control
Ste rile products
Legal and regulatory issuts
Patient counseling
Child abuse reponi ng
Other topics that contribute to rhe practice of pharmacy
matters care, law, and ethi cs that contribute fo the
public's health and wel fa re.
Sponsors must be approved
American Council on Pharmaceutical
Education
Colleges, universities, other degree granting
institutions registered by the Education
Department or accredited by an equivalent
agency
Sponsors approved directly by the Department
One CE credit equals:
6o minutes or
One contact hour
0 .1 CEU
One semester hour = 15 contact hours= 1.5
CEUs = 15 credits
One quarter hour = 10 contact hours = 1.0
CEUs = 10 credit hours
18
Professional Misconduct
Education Law: Article 130 Sub article 3: 6509- 6511
Obtaining license fraudulently
Practicing fraudulently, beyond scope of
practice, with gross incompetence, with
gross negligence
Practicing while influenced
Habitual user of drugs
Unprofessional Conduct for Health
Professionals
Rules of the Board of Regents: Part 29: 29.2
Abandoning or neglecting a patient under
and in need of immediate professional care
without making arrangements
Abandoning professional employment
without reasonable notice
Willfully harassing, abusing or intimidating
a patient either physically or verbally
Failing to maintain a patient record
accurately reflecting treatment
Professionals
Ordering excessive tests, treatments, or use
of treatment facilities not warranted by
condition
Failing to wear an identification badge
5/22/2013
Professional Misconduct
Being convicted of a crime
Refusing to provide services due to a
person's race, creed, color, or national
origin
Allowing an unlicensed person to perform
professional activities
Practicing with a suspended license, failing
to register or notify of name/ address
change
Professionals
Using the word "Doctor" in offering
professional services without also
indicating profession
Failing to exercise appropriate supervision
over persons over those who are required
to be supervised
Guaranteeing satisfaction or a cure will
result from performance of professional
services
Unprofessional Conduct for
Pharmacists
Rules of the Board of Regents: Part 29: 29.2
Not following regulations for written
prescriptions, labels, medication orders,
oral prescriptions, dispensing a
prescription, refills, substitutions
Failure to number prescriptions properly
Failure to maintain appropriate records
Failure to make prescription drug list
available
19
Unprofessional Conduct for
Pharmacists
Placing in stock a prescription
compounded or dispensed after returned
by patient
Selling adulterated or misbranded drugs
Selling outdated or improperly stored
drugs
Registrations for Establishments
Educati on Law: Articl e 137:6808
Required of all individuals, partnerships, or
corporations who possess drugs,
prescriptions or poisons for the purpose of
compounding, dispensing, retailing,
wholesaling, or manufacturing, or who
offer drugs, prescriptions or poisons for
sale at retail or wholesale
Pharmacy as a Department
Shall be physically separated from the rest
of the establishment
Access to department is not available when
there is no pharmacist present
Identification of the area shall be restricted
to the area licensed by the department as
pharmacy
5/22/2013
RULES OF THE PHARMACY
Registrations for Establishments
Education Law: Article 137:6808
Regulations of h ~ Commissioner: Part 63: 63.6a
Separate registration required for each pharmacy
An application for endorsement to another address
shall be made no less than 30 days pri or to expected
date of relocation
Must be conspicuously displayed at all times
Names of owners conspicuously displayed upon the
exterior of the establishment
If owner is not a pha rmacist, must bear name of
supervi sing pharmacist
Pharmacy Requirements
Regulations of the Commissioner: Part 63: 63.6b
To secure and retain registration, need at
least the following:
weighing device sensitive to 6 mg;
metric weights, if needed
devices capable of measuring volumes from 0 .1
ml to soo ml; and
a mortar and pestle.
20
Pharmacy Requi rement s
Not less than 300 square feet
Include a manufacturing, compounding area of
not less than 100 feet
Equipped with st orage facilit ies providing
for safe storage of drugs
Adequate heating, vent ilation and lighting
Hot and cold running water
Pharmacy Requirements
Pharmacy as a Department
Enclosed permanently by a partit ion at least
9'6" unless t he ceiling is less than 9'6"
The partition must be from floor to ceiling
When not opened during all hours maintained
by the establishment, an exterior sign should
be post ed clearly indicating the hours '
Limited Pharmacy Registration
Department may waive any requirements
pertaining to:
Full-time operation
Minimum equipment
Minimum space and waiting area
5/22/2013
Pharmacy Requi rements
Refrigerator equipped with thermometer
(2c-sC)
Copies of the laws, rules and regulations
governing the practice of NYS
Ot her up-to-date reference books
necessary to carry on practice
Limited Pharmacy Regist ration
Pharmacy within a hospital, nursing home
or extended care facility does not meet all
requirements for registration
But can provide high standard of patient safety
with good patient care
Pharmaceutical services shall be limited to
the pat ients registered for treat ment by the
various facilites
Nonresi dent Est ablishment s
Education Law: Article 137:6808-b
Regulations of the Commissioner: Part 63 Pharmacy: 63.8
Any pharmacy, manufacturer, or
wholesaler located outside of the NYS that
ships, mails, or delivers prescription
drugs/ devices to other establishments,
author ized prescribers residing in NY.
Shall include int ernet pharmacies
21
Nonresident Establishments
Agent of record
A designee residing in NY for service of process
Must provide a toll free number that is
available during normal business hours and at
least 40 hours per week
Enable communication between a patient and a
pharmacist
Number must be placed on a label affixed to
each drug or device container
Drug Retail Price List
Pharmacy Requirements-
Radioactive
Part 63: 63.6b (6)
Need to meet requirements as stated in 10
NYCRR Part 16 (medical and academic
facilities) or 12 NYCRR Part 38 (commercial
facilities)
Must have appropriate license issued by
NYS Dept. of Health or Labor
Pharmacy Requirements-
Radioactive
Shall also be equipped with the following:
Laminar flow hood
Dose calibrator
Exhaust hood and folter system
Chromatography apparatus
Apparatus or materials for the determination of pH
Single-channel and/or multichannel scintillation
detection system
Microscope
5/22/2013
Nonresident Establishments
Registration requirements
Licensed and registered in state of origin
Maintain records in readily retrievable form
Supply information upon request
Comply with all statutory and regulatory
requirements of residing state for prescription
drugs or devices shipped, mailed or delivered
into NY
For CS must follow federal and NY law
Pharmacy Requirements -
Radioactive
One pharmacist should be present at all
hours when the pharmacy is open
meeting:
Minimal standards of training and experience
Submitted to the state board either:
Certification as Nuclear Pharmacists by BPS
Completion of minimum 200 contact hours of
didactic instruction in nuclear pharmacy and a
mi nimum of soo hours training under the
supervision of a board certified nuclear pharmacist
in a certified nuclear residency/training program
Pharmacy Conduct
Education Law: Arti cle 137: 6808
Every owner of a pharmacy or every
pharmacist in charge of a pharmacy shall
be responsible for the proper conduct of
this pharmacy.
A pharmacist must be present at all hours
when open
One pharmacy per supervising pharmacis t
22
Supervising Pharmaci st
Rules of the Board of Regents Part 29: 29.7a (10)
Each registered pharmacy must be under
the supervision of a registered pharmacist
The SP is responsible for ensuring
compliance of all rules and regulations
Oversees all employees of the pharmacy
May not assign responsibility to others
Must have active role in pharmacy
Change of Supervisor
The owner shall notify the department with
the name of the replacement pharmacist
Apply for an amended registration
Attach to original registration
Both owner and supervising pharmacist
shall be responsible for carrying this out
Must be done within 7 days of change
Pharmacy Intern
May practice as a pharmacist under the
immediate personal supervision of a
pharmacist
When a prescription is dispensed by an intern,
must have both intern's and pharmacist's
initials
5/22/ 2013
Supervising Pharmacist
Must practice at pharmacy full time
At least 30 hours a week
If pharmacy is open less than 30 hours a
week:
Must be present for the majority of hours
Pharmacy Intern
Limited permit authorizing the practice of
pharmacy under the immediate and
personal supervision of a registered
pharmacist
Must have completed first year of professional
study OR
A graduate of a pharmacy program who is
engaged in meeting the experience
requirements or whose application is pending
Expiration date of 5 years
Precept or Pharmacist
Part 63: 63.2a (3A)
Must have practiced at least one year
Cannot supervise no more than one full
time intern or two part-t ime interns
In pharmacy training interns, one intern
for each sooo prescriptions dispensed
annually
23
Unlicensed Assi stants
Part 29: 29.7a (21)
Does not include interns, staff not directly
related to the filling of prescriptions
Up to two unlicensed persons may assist a
pharmacist
Unl icensed Assistants- Allowed
To ...
Count dosage units of drugs
Place dosage units of drugs in appropriate
containers
Affix the prescription label to the containers
Prepare manual records of dispensing for the
signature or initials of the pharmacist
Hand or deliver completed prescriptions to the
patient or the person authorized to act on behalf
of the patient
Unlicensed Assistants- Not
Allowed To ...
Measure, weigh, compound or mix
ingredients
Sign or initial any record of dispensing
required to be maintained by law
Counsel patients
Perform any other function involving the
exercise of professional judgment
5/22/2013
Unlicensed Assistants- Allowed
To ...
Receive written or electronically transmitted
prescriptions, except that in the case of
electronically transmitted prescriptions
Type prescription labels
Key prescription data for entry into a computer-
generated file or retrieving prescription data from
the file
Get drugs from stock and returning them to stock
Get prescription files and other manual records
from storage and locating prescriptions;
Unlicensed Assistants- Not
Allowed To ...
Receive oral prescriptions from prescribers
Interpret and evaluate a prescription for
conformance with legal requirements,
authenticity, accuracy and interaction of
the prescribed drug with other known
prescribed and over-the-counter drugs
Make determinations of the therapeutic
equivalency as such determinations apply
to generic substitution
Reporting Requi rements
Transfer of ownership
At least 6 weeks prior to proposed date
Change in corporate officers and/ or
principal stockholders
NotifY within 30 days
Fire, flood, disaster
Within 48 hours of damage
Change in Supervisor
Within 7 days of any change
24
Reporting Requirements
Change of location
Not less than 30 days prior to the expected
date or r elocation
Renovations
Should be reported prior t o any renovations
Change in corporate name
Notify prior to use of any new name
Drug Retail Price List
Regulations of the Commissioner: Part 63, Pharmacy:63.6(9)
Sign posted notifyi ng patients of the availability of
a drug retail price list
"Drug Retail Price List Available Upon Request" in
bold, block letters of at least one inch in height
Drugs on list provided by the board of pharmacy
150 most frequently prescribed drugs
Updated weekly
Contain advisory statement
Need to tell heal th care practitioner and pharmacist
about medications/avoidance of harmful interactions
Prescriptive Authority
PRESCRIPTIONS
5/22/2013
Reporting Requirements
Temporary closing
Notify prior to any such closing as well as prior
to reopening
Sale of drugs at Auction
Must be notified at least seven days prior to
auction
Drug Retail Price Li st
Retail price means the actual price to be
paid
Web-based pharmacies must post
Notice of the availability
Provide a toll-free number
Mail-order pharmacies
Provide a printed notice with each delivery
informing the patient about t he availabilty
Provide a t oll-free number
Prescription
A prescription shall be issued by a
practitioner for legitimate medical purposes
in good faith and in the course of his or her
professional practice only.
25
Who Can Prescribe?
Traditional Prescribers
Doctor of Medicine (M.D.)
Doctor of Osteopathy (D.O.)
Doctor of Dental Surgery ( D.D.S.)
Doctor of Dental Medicine (D.D.M.)
Doctor of Podiatric Medicine (D.P.M.)
Doctor of Vet erinary Medicine (D.V.M.)
Midwife
Management of normal pregnancies, child
birth and postpartum care as well as
primary preventive reproductive health
care of essentially healt hy women
Include newborn evaluation, resuscitation
and referral for infants
Midwife
May prescribe and administer drugs,
immunizing agents, diagnostic tests and
order lab tests limited to the practice
Includes controlled substances
Register with state
License number begins with F + 6 digits
Own prescription blanks
5/ 22/2013
Who Can Prescribe?
Under certain conditions:
Midwife
Nurse practitioner (NP)
Certified optometrist
Registered physician assist ant (R. P.A.)
Those not allowed:
Doctor of Optometry (O.D.) (unless certified)
Doctor of Chiroparactic Medicine (D.C.)
Optician or Ophthalmic dispenser
Midwife
Midwifery shall be practiced in accordance
with a written agreement between the
midwife:
A licensed physician who is board certified as
anOB/ GYN
A licensed physician who practices obstetrics
and has obstetric privileges at a hospital
A hospital that provides obstetrics through a
licensed physician
Nurse Practitioners
Obtain a certificate from the department
upon successfully completing a program
including an appropriate pharmacology
component, or its equivalent
Must have collaboration with a physician
Must be kept on file with the physician, with
t he State Education Department and at the
NP's practice site
26
Nurse Practitioners
May prescribe for controlled substances
Must have DEA number
License registration will begin with an F + 6
digits
First two digits represent specialty area
May have own prescription blanks with
name and designation imprinted
Optometrist
Must be certified by NYS Education
Department
Those who are certified can be identified by
letter preceding their license number:
T = diagnostic agents
U = Phase One agents
V = any agent
Own prescription blank
Optometrist - Phase One
Completed at least 300
hours of dinicalt:raining in
the diagnosis, creatment and
management of patients
with ocular disease other
than glaucoma and ocular
hypertension
Successfully passed the
t:reaonent and management
of ocular diseases portion of
the National Board of
Examiners in Optometry test
Antibiotics
Decongestants/anti-
allergenics
NSAIDs
Steroidal anti -
inflammatories
Antivirals
Hyperosmotics/hypertonics
Cycloplegics
Artificial tears and
lubricants
Opt ometrist
Optometrists who have satisfactorily
completed a curriculum in general and
ocular pharmacology at a college of
opt ometry with didactic and supervised
clinical programs approved by the
department are eligible to apply for
prescriptive authority
Optometrist- Diagnostic Agents
Mydriatics
Miotics
Cycloplegics
Anesthetics
Optometrist - Phase Two
Must be certified for
diagnostic and phase one
therapeutic agents
Completed an additional
one hundred hours of
clinicalt:raining in the
diagnosis, t:reat:rnent and
management of patients
with glaucoma and ocular
hypertension
Successfully passed an oral
or written examination
acceptable by the board
Alpha-agonists
Beta-blockers
Direct acting
cholinergics
5/ 22/2013
27
Physician Assistant
NYS Public Health Law: Article 37: 3702
A dependent practitioner working under
the supervision of a licensed physician
responsible for the actions of the P.A.
If delegated by physician, may write
medical orders and prescriptions
Inpatient: may order medications, including
CII - V (may require physician's
countersignature within 24 hours)
Outpatient: may prescribe medications
including CII-V
Obligation to Fill a Prescription
Pharmacists may refuse to fill or refill a
prescription for good reason, including:
Drug out of stock
Suspect the prescription is forged
Believe that the medication will be harmful to
the patient
Know t hat the refilling of the prescription
violates the law
Patient Profiles
Part 63: 63.6b (7)
Must include but not limited to;
Name, address, phone of patient
Gender and date of birth
Known allergies/drug interactions
Chronic diseases
Comprehensive list of medications and relevant
devices
Other information reported to the pharmacist
appropriate for counseling the patient regarding the
use of prescriptions and OTC drugs
5/22/2013
Who May Dispense?
Pharmacist acting in the usual course of
professional practice
Registered individually or employed by a
registered pharmacy or registered institutional
practitioner.
Includes those individuals authorized to
dispense under the supervision of a
pharmacist (varies from state to state)
Patient Profil es
PRESCRIPTIONS
Prospective Drug Review
A prospective drug review is to be done prior to
the dispensing of each prescription
The review shall include screening for potential
drug therapy problems due to:
Therapeutic duplication
Drug-disease contraindications
Drug-drug interactions (incl uding OTCs)
Incorrect drug dosage or duration of therapy
Drug-allergy interactions
Clinical abuse/misuse
28
Pat ient Counseling
PRESCRIPTIONS
Patient Counseling
Part63: 63.6b (8)
A pharmacist or pharmacy intern must
provide patient education (counseling):
Before dispensing a medication to a new
patient of the pharmacy;
Before filling a new prescription for an existing
patient of the pharmacy; and
If the dose, strength, route of administration,
or directions for use has changed for an
existing prescription previously dispensed to
an existing patient of the pharmacy.
Patient Counseling - Mail Order
and Internet Pharmacies
Must include written notification that counseling
is available
provide a toll-free number where the pharmacist or
pharmacy intern can be readily reached
If there are potential drug therapy problems
patient must be contacted prior to fi lling the
prescri ption
offer to counsel provided personally by the pharmacist
or int ern
If declined- must be documented
5/22/2013
OBRA 90
Omnibus Budget Reconciliation Act
In order to participate in the Medicaid
program, states must have:
Drug use review programs in place
Pharmacists "offer to counsel"
Manufacturers to pay rebates to the states for
pharmaceuticals
Pharmacists to make a reasonable effort to
obtain, record, and maintain patient
medication records
Patient Counseling - Refills
An offer to provide counseling must be
made every time a patient has a
prescription refilled or has a prescription
filled for a medication therapy that has
been reauthorized by a prescriber
Any member of the pharmacy staff can
make the offer to counsel
A pharmacist or pharmacy intern must be
available to provide counseling.
Patient Counseling- Mail Order
and Internet Pharmacies
If received approval for an alternative drug,
the pharmacist must:
include a notice of the change with the order,
the directions for use and availability of
counseling
make reasonable effort to contact patient by
phone to personally offer counseling
A telephone call is not required for generic
substitution.
29
Counseling Requirements
Name and description of tht medication and known indications;
Dosage fonn, dosage, route of administration and duration of drug
therapy
Special directions and precautions for preparation, administration
and use by the patient
Common severe side or adverse effects or interactions and
therapeutic contraindications that may be encountered, including
their avoidance, and the action l'equired if they occur
Techniques for selfmonitoring drug therapy
Proper storage
Prescription refill information
Action to be taken in the event of a missed dose
Limited English Proficient Patients
Every covered pharmacy shall provide free,
competent oral interpretation and translation
services to those requesting or filling a
prescription that indicates need
Includes medication labels, warning labels and
other written material
A notification of the right to free, competent
oral interpretation services must be
conspicuously displayed at each counter
where prescription drugs are sold
Health Insurance Portability &
Accountability Act of 1996
To assure the security and privacy of
patients' medical records while allowing
the flow of health info rmation needed to
provide high quality patient car e
To limit the use, requests for, or disclosure of
protected health information (PHI)
5/22/2013
Limited English Proficient Patients
"LEP" individual
An individual who identifies as being, or is
evidently, unable to speak, read, or write
English as a level that permits such an
individual to understand health-related and
pharmaceutical information communicated in
English
HI PAA
FILLING AND DISPENSING
MEDICATIONS
HIPAA
"Notice of Privacy Practices" must be given
t o each patient when first pr ovided services
in the pharmacy
Record of required signatures must be
maintained for 6 years from date received or
from last date a prescript ion is dispensed
"Notice of Privacy Practices" must be
posted in the pharmacy in a prominent
location and on the website
30
HIPAA
Patient records must be held secure
Specific consent must be granted for PHI to be
disclosed to other persons on behalf of the
patient
Name of drug or its use should not be provided
upon telephone request-must use discretion
Permissible for pharmacist using professional
judgment to allow a relative or friend to pick
up a filled prescription
Official NYS Prescription
PRESCRIPTIONS
Official NYS Prescription Form
Previously certain facilities were exempt
from using the ONYSRx for non-controlled
substances
By April1g, 2007 the exemption will continue if
the facility implemented an electronic
prescription system
Each faci lity must now affix facility labels to all
written prescriptions
National Provider Identifier
HIP M required adoption of standard
unique health identifiers for healthcare
providers
All health care providers are eligible
Use the NPI for administrative and
financial transactions adopted under
HIPM
It is a 10-digit intelligence-free identifier
(ONYSRx)
5/22/2013
Titfe 10- NYCRR, Part 910 - Official New York State Prescript ion Forms
Administered by Bureau of Narcotic
Enforcement
Must be used for ALL prescriptions
Intent of form is:
Minimize fraud and forged prescriptions
Minimize health care costs
Encourage e-prescribing
Title 10 - NYCRR, P81rt 910 - Official New York State Prescription Forms
PHL Article 2-A Tit le 3 281
A section where the prescriber may
indicate whether a patient is limited
English proficient shall be included
Line will be provided on t he form where the
preferred language can be specified
31
... i
l
---- : -: I
- . I
Da_ ...

.......... _;. ............_ .. _
. .... -
L .. Lr.J
I
)l<is-4614
llUIIIIIIItU I
Practitioner must take appropriate
safeguards and security measures to assure
against the loss, destruction, theft or
unauthorized use of these forms
BNE must be notified of the loss,
destruction, theft or unauthorized use as
well as failure to receive the forms after
placing an order
Prescription Requirements
Part 29: 29. 7a (1)
Date prescription was issued
Prescriber
Name and Profession
Full address and phone
NYS license number
Signature
Patient
Name
Full address and age
Name, strength. quantity, directions for use of
medication prescribed
5/22/2013
ONYSRx- Safety Features
Word VOID will appear if it has been
copies, scanned, or physically or chemically
erased
Pharmacist test area - is heat sensitive
Color will change from blue to light blue or
transparent when rubbed
Secure standard register - on back
Heat sensitive - color will change from orange
to yellow when rubbed
Requirements
PRESCRIPTIONS
Adding/Changing Information on
an Rx
A pharmacist may add
Patient's address and/or age
Telephone, state license# and profession of
prescriber
Do not need authorization from the
prescriber
Information does not have to be added if it
is readily available to the pharmacist
32
Adding/Changing Information on
an Rx
A pharmacist may add/change the
following with authorization from the
prescriber:
Strength of medication
Quantity
Directions for use
Refills
Multiple Prescriptions
Educati on Law: Article 137:6810 (7)
Only one drug per prescription
Exception:
If originated from a long term care facility
Drug product+ hypodermic syringes/needles
Only applicable to prescriptions written in
NYS
Oral Prescriptions
No legally mandated form to be used
Contains same information as an original
prescription except for signature
Generic substitution must be discussed
Pharmacist or intern must sign or initial
5/22/2013
Items a Pharmacist Can Never Add
Patient Name
Date Rx Was Written
Medication Name
Signature of Prescriber
Oral Prescriptions
Education Law: Arti cle 137:6810(4) and Part 29: 29.7a(2)
Telephone prescription or oral
authorization for a refill may be
communicated by an employee of the
prescriber upon their authorization
Reduce prescription to writing
Dispense product in conformity with the
labeling requirements
Make a good faith effort to verify employee's
identity
Electronic Prescriptions
Part 63: 63.6a(7)
A prescription created, recorded, or stored
by electronic means
Issued and validated with an electronic
signature
Transmitted by electronic means
33
Electronic Prescriptions
Electronically submitted prescriptions
must:
contain prescriber's electronic signature
be electronically encrypted; protected from
unauthorized access, alteration or use
Be stored securely and permanently and
maintained at the pharmacy for a period of 5
years
Refill Instructions
May accept
A number of times
A time period
Pro re nata - prn
Allowed to refill only once
Prescriptions - Documentation
At the completion of processing a
prescription, a pharmacist must "cancel"
the Rx. After this occurs, the Rx must be
placed in the proper prescription fil e and
stored for five years according to NYS law.
5/22/2013
Prescription Refills
Education law: Article 137:6810(2,4, 5) and Part 29: 29.7a(4,8)
Cannot refill a prescription unless
indicated on face of prescription or receive
oral authorization
If receiving oral authorization, must record
on back of prescription:
Date
Time
Name of authorizing prescriber
Initials of pharmacist/intern receiving
Prescription Refill -Documentation
Enter refill information on back of
prescription
Date of refill
Signature or initials of pharmacist
If using a computer system
No need to enter on back of prescription
Initials of pharmacist are entered at time of
dispensing
Prescriptions - Documentation
Part 29: 29. 7a(3)
To "cancel" a prescription, the pharmacist
MUST:
Initial the face of the Rx (or sign in full if a
controlled substance is dispensed)
Write the Rx number
Write the date of fill
For generic drugs ONLY!!
Write the name of the mfgr./dist.
34
Labeling Requirements
Education law: Article 137:6810(1)
Education Law: Article 137:6816a(1)
Rules of the Board of Regents: Prt 29: 29.7 (6)
Must be affixed t o immediate container
Name and address of t he owner of t he pha rmacy
Rx number
Date fill ed
Name, address of patient
Name and strength of drug
Directions for use
Name of prescriber
Name of manufact urer (and dist ri butor if different)
Generic Substitution
PRESCRIPTIONS
Definitions
Pharmaceut ical alternative
Different salts and esters of t he same
therapeutic moiety
Are not considered therapeutic equivalents
5/ 22/2013
Standardi zed Patient Centered Data Elements
Education Law: Articl e 137:6830
Critical Elements
Patient name
Directions for use -
st ructured in full sentences
Drug name and strengt h
Shall be:
Emphasized by being
highlighted in color, bold, or
both
Minimum of 12-point font
Important Elements
Name, address, telephone of
pharmacy
Patient's address
Name of prescriber
Date of filling
Prescription number
Shall not be highlighted or in
bold, shall be legible and not
presented in a rashion that
undermines the emphasis of
critical elements
Def init ions
Bioavailability
Rate and extent to which the active ingredient
is absorbed from the drug product and is
available at the site of its int ended action
Bioequivalent drug pr oducts
Pharmaceutically equivalent products that
display comparable bioavailability
Defi nit ions
Pharmaceut ical equivalent
Drug products having same active ingredient,
same dosage form, identical strength and route
of administration
Therapeutic equivalent
Approved by FDA as safe and effective
Pharmaceutically equivalent
Bioequivalent
35
Education Law: Article 137:6810(6)
All prescription forms used by prescribers in NYS
must contain one signature line
Imprinted beneath is the legend:
"THIS PRESCRIPTION WILL BE FILLED
GENERICALLY UNLESS PRESCRI BER WRITES 'd
a w' IN THE BOX BELOW
"d a w" must be written in prescriber's own
handwriting or electronic direction
Pharmacist has liability for substituting
properly
To determine therapeutic equivalence of
products:
Approved Drug Products with Therapeutic
Equivalence Evaluation or the Orange Book
http://www.fda.gov/cder/ ob/defaul t.htm
USPDI
Approved Bioequivalence Codes
FDA'swebsite
FDA Coding System
A - Drug product that FDA considers to be
therapeutically equivalent to other
pharmaceutically equivalent drug products
B - Drug products that FDA at this time
considers not to be therapeutically
equivalent to other pharmaceutically
equivalent products
5/ 22/2013
Generic Substi tution
A pharmacist shall substitute a less
expensive drug product containing the
same active ingredients, dosage form and
strength as the drug product prescribed
Prescriber is responsible for informing the
patient whether they have prescribed a
brand name or generic equivalent
Generic Substitution- Not
Required
When a generic drug is not available and
brand name drug is - pharmacist agrees to
charge a price that will not exceed the price
of the generic substitution
If generic drug is not available and a
medical emergency situation exists, brand
name may be dispensed at regular price
Must record date, hour and nature of
emergency on back of prescription
A codes
No known or suspected bioequivalence
problems
Designated by AA, AN, AO, AP, or AT:
depending on dosage form
Actual of potential bioequivalence
problems have been resolved with
adequate in vivo and/ or in vitro evidence
Designated AB
36
B codes
Drug products for which actual or potential
bioequivalence problems have not been
resolved by adequate evidence of
bioequivalence
Designated by BC, BD, BE, BN, BP, BR, BS, BT,
BX, orB*
Transfers
PRESCRIPTIONS
Transferring Pharmacist
Name of the patient
Authorized refill of the prescription has
been transferred
Name, address and telephone number of
the pharmacy to which it was transferred
Name of the pharmacist receiving
Name of the pharmacist transferring
Date of the transfer.
5/22/2013
Shall indicate on label affixed to immediate
container
Name and strength
Manufacturer
Record on prescription
Name of manufacturer and distributor
Transfer of Refills
Part 63: 63.6a(8)
Patient must initiate request
Must occur one at a time
Original pharmacy may continue to dispense
remainder of authorized refills
Cannot transfer:
Medicaid prescriptions
Syringes/ Needles
If there are no authorized refills
Receiving Pharmacist
Name of the patient
Authorized refill of the prescription has been
transferred
Name, address and telephone number of the
pharmacy from which it was transferred
Name of the pharmacist receiving
Name of the pharmacist transferring
Date of the original prescription and most recent
transfer
Original prescription number.
37
Record Keeping
PRESCRIPTIONS
Dail y Log
Electronic system
Provide adequate safeguards against improper
manipulation or alteration
Assures completeness and continuity of
prescription records
Provide ret rieval of information regarding original
dispensi ng and refi lling of prescript ions
Pharmacist or intern signature or initial on
original prescription at time of first dispensing -
initials entered into computer record
Records
Education Law: Articl e 137: 6810 (5)
Records for all prescriptions fill ed or r efi lled shall
be maintained for a period of at least 5 years
Records shall indicate:
Date of fi lling or refilling
Prescriber's name
Patient's name and address
Pharmacist's name or initials
Upon request made available for inspection and
copying by a representative
Daily Log
Board of Regents: Part 29: 29.7 (8)
Daily record
Ready retrieval of all prescriptions filled and
refilled which identifies:
Practitioner who ordered t he prescription
Patient name
Rx number
May be maintained by manual system of
elect ronic dat a processing system
Daily Log
Elect ronic system
For refills
Signature or ini t ials of pharmacist who dispensed are
entered at ti me of dispensing
Printout or electroni c record is produced of all
prescriptions filled and refilled daily and pharmacist
whose signature or initials appear either manually or
electronically sign
Must have auxiliary procedure duri ng system
downtime
Only pharmacists or interns shall enter
prescript ion data into system and access data
Part 8o
CONTROLLED SUBSTANCES
5/22/ 2013
38
Controlled Substances Act
The principal federal law regulating the
manufacture, distribution, dispensing and
delivery of drugs or substance which are
subject to or have the potential for abuse,
physical or psychological dependence
States have their own laws
Pharmacists practicing should follow the
more stringent law.
Narcotic- Definition
A natural or synthetic opium or opiate and
any derivative such as poppy straw, coca
leaves, ecgonine, and cocaine
Any mixture that contains any amount of
any substance referred to in t his section.
Schedule II Substances
High abuse potential
May lead to severe psychological or physical
dependence
Has a currently accepted medical use in
U.S. or an accepted medical use with severe
restrictions.
5/22/2013
Drug Enforcement Agency
Agency of U.S. Department ofJustice
A unit of the Federal Bureau of Investigation
Implements and administers all parts of the
CSA
Restates the law and applies it to specific
situations
Provides the Pharmacist Manual- an
Informational Outline of the Controlled
Substance s Act oj1970
www.deadiversion.usdoj.gov
Schedule I Substances
21 CFR 1308 11
High potential for
abuse
No currently accepted
medical use in U.S.
Lack of accepted
safety for use, even
under medical
supervision
Heroin
Marijuana
Lysergic acid diethylamide
(LSD)
Peyote

Psilocybin
o Tetrohydocannabinol (THC)
o MDMA (Ecstasy)
Methcathinone (CAT)
Gamma Hydroxybutyric Acid
(GHB)
Opiates and Opioids
Ti ncture of Opium
Morphine
Codeine
Fentanyl
Hydromorphone
(Dilaudid)
Methadone
Meperidine
Alfentanyl
Levorphanol
Cocaine and its salts,
isomers, derivatives and
salts of isomers and
derivatives
Oxycodone (Percocec,
Oxyconcin)
Oxymorphone
Oripravine
Sufentanyl
Nabilone
39
Stimulants
Amphetamine
Methamphetamine
Methylphenidate
Phenmetrazine
Hallucinogens
Phencyclidine (PCP)
Depressants
Amobarbital (Amytal)
Pentobarbital
(Nembutal)
Secobarbital (Seconal)
Barbituate
combinations
Schedule Ill Substances
Any compound, mixture, or preparation
containing amobarbital, secobarbital,
pentobarbital, or their salts, combined with one
or more active ingredients t hat are not listed in a
schedule. OR any suppository dosage form
containing amobarbital, secobarbital, or
pentobarbital, or t heir salts
Benzphetamine (Didrex)
Phendimetrazine (Bontril)
Anabolic Steroids Control Act of 1990
Required anabolic steroids to be placed in CIII
category due to increased use
Some are exempt due to no potential for abuse
- Syntest H.S. and Syntest D.S.
Be aware that federal and state
classification of anabolic steroids may vary.
5/22/2013
Potential for abuse is less than those in I
and II
Abuse of drug may be dangerous or lead to
moderate or low physical dependence or high
psychological dependence
Currently accepted medical use in U.S.
Acetaminophen with Codeine
Buprenorphine
Buprenorphine/ Naloxone
Butabarbital
Butalbitai/Aspirin/CafTeine
Butalbtal/Aspiri n/C.affeine/Codei ne
Dronabinol
Nalorphint>:
Thiopemal
Gamma Hydroxybutyrate (GHS, sodium oxybate)
Keta.mine
Pal'egoric
Schedule Ill - Restrictions
s 1.8 grams of codeine or dihydrocodeine
per 100 mLs or s 90 mg per dosage unit
s soo mg of opium per 100 mLs or per 100
grams or s 25 mg per dosage unit
s so mg of morphine per 100 mLs or per 100
grams
s 30omg of ethylmorphine per 10omL's or s
15 mg per dosage unit.
40
Schedule IV Substances
Low potential for abuse relative to those in
schedule I, II and III
May lead to limited physical or psychological
dependence
Currently accepted medical use in
treatment in U.S.
Schedule V Substances
Low potential for abuse relative to C-IV
Limited physical or psychological dependence
Currently accepted medical use in U.S.
Schedule V Substances -
Restricti ons
s2oo mg of codeine per 100 mLs or per 100
grams
s1oo mg of ethylmorphine per 100 mLs or per
100 grams
s2.5 mg of diphenoxylate and not less than 25
meg of atropine sulfate per dosage unit
900 mg of opium per 100 mLs or per 100
grams
s o.5 mg of difenoxin and not less than 25 meg
of atropine sulfat e per dosage unit
5/22/2013
Schedule IV Substances
Benzodiazepines Butorphanol
Chloral hydrate Chlordiazepoxide
Fenfluramine Eszopiclone
Meprobamate Diethylpropion
Phenobarbital Pemoline
Zaleplon Pentazocine
Zolpidem Phentermine
Carisoprodol Sibutramine
Schedule V Substances
Includes:
Antitussive preparations that contain codeine
Antidiarrheal products that contain an opiate
Pregabalin
Ezogabine
Lacosamide
Schedule of Drugs in NYS
Article 33: New York State Controll ed Substance Act
Schedule II
Anabolic Steroids (Federal CIIJ)
Hydrocodone combination products
Benzodiazepines (Federal CIV)
Schedule III
Chorionic gonadotropin
Schedule IV
Tramadol
41
Licenses for Control led Substances
Part 80: 80.5
Manufacturers and
Distributors
1 - Manufacturer
1a - Manufacturer out of
state
2 - Distributor
2a - Distri butor out of
state
Institutional dispensers
3- Instituti onal
33 - Institutional
dispenser, limited
Research and
instructional
4- Researcher II ro V
40 - Researcher
industrial I! to V
5 - Instructional
activities II to V
6 - Treatment
programs, methadone
Who May Prescribe
Part 80: 80.64
A practitioner who is:
Authorized to prescribe pursuant to his
licensed professional practice AND
Either registered under the Federal Controlled
Substances Act and in possession of a
registration number from the DEA, US Dept of
Justice, or its successor agency, or exempted
from such registration as an exempt official
Prescription
An official NYSRX
Written in ink, indelible pencil, typewriter
Electronic prescription
Oral prescription
Out of state prescription
5/22/2013
Licenses for Controlled Substances
Research and
instructional
6a -Treatment
programs, methadone
and other substances
6b - Hospital
pharmacies detox,
temporary treatment
7- Research and
instructional activities I
8- Analytical
laboratories
Importers and
exporters
9 - Importer
10 - Exporter
1oa - Exporter broker
Registered
Community Pharmacy
u - Registered
Community Pharmacy
-Automated
dispensing system
Purpose of Issue
Part 80: 80.64
Shall be issued for legitimate medical
purposes only
Responsibility for the proper prescribing and
dispensing of CS shall be on the authorized
prescriber, but a corresponding liability shall
rest on the pharmacist who fills the prescription
No controlled substance prescription shall
be issued prior to examination
Must have legitimate medical purpose
Must be signed by the practitioner
Valid for only 30 days from date issued
42
Must contain:
Patient's name, sex, age
Printed name, address, DEA #, phone, and
handwritten signature
Specific directions for use, including but not limited to
dosage, frequency of dosage and maximum daily dose
Date of issue
Quantity in both numeric and written form
Refills
No cefills allowed on CII
Max ofs refills on CHI - Vs (quantity in both numeric and
written form)
Missing Information
After receiving authorization, may add:
Practitioner DEA, phone,
Directions for use
Drug strength
Maximum dose
Pharmacist must sign and date after receiving
authorization
Can add after good faith effort:
Patient address
Age and gender
Oral Prescriptions
Only pharmacist or intern may receive
Must be communicated by prescriber
Contemporaneously reduce to writing
Dispense in conformity with labeling
requirements
Make good faith effort to verify identity of
both practitioner and patient
5/22/2013
Missi ng Information
Cannot add if missing:
Patient' s name
Date
Name of drug and/ or quantity
Signature
Changing Information
Practitioner may orally authorize change
May not change
Signature
Date
Drug name
Patient name
Pharmacist must
Record date of change
Reason for change
Signature
Oral Prescriptions
Clls
Emergency oral
prescriptions
Cannot exceed a 5 day
supply
CIII- Vs
Emergency not requi red
CIJ I and V
supply
CIV
supply or 100 dosage uni ts
whichever is less
43
C-11 Emergency Situations
Immediate administration is necessary for
proper treatment of patient
No appropriate treatment alternative is
available (including non-CII drugs)
It is not reasonably possible to provide a
written prescription prior to dispensing
Oral Prescriptions- Clll- Vs
Within 72 hours pharmacist must receive
ONYSRx
Must exactly match oral order
Pharmacist shall endorse upon the face of
prescription
Follow-up
Date of filling, Rx #
Signature
Quantity shall not exceed a 30 day supply if
substance were used according to
directions of use
No additional prescriptions may be issued
by the practitioner within 30 days of the
date of any previous prescription
Unless patient has used all but a seven's day
supply provided by any previous issued
prescription
5/22/2013
Oral Prescriptions- Clls
Within 72 hours pharmacist must receive ONYSRx
Must exactly match oral order
Pharmacist shall endorse upon the prescription
Date of delivery
Signature
Must also have upon its face: "Authorization for
emergency dispensing'
If do not receive such a prescription, pharmacist shall
notify the department within 7 days from the date of
dispensing
Oral Prescriptions- Clll - Vs
On back of prescription
"Follow up prescription to oral order,
pharmacy prescription number XXXXX, oral
order filled on XXXX, follow-up prescription
received XXXX
If cover not received, shall record on oral
prescription
"Official prescription not received"
Name of pharmacist
Date of recording
. May issue a prescription for up to 3 mont hs or up to 6
months of an anabolic steroid if:
Code Description
A Panic Di sorder
B Attention Deficit Disorder
c Chronic debilitating neurologic conditions characterized as a movement
disorder or 6hibiting seizure, convulsive, or spasm llCt ivicy.
D Relief of pain in patien ts suffering from diseases known chron ic or
incurable.
E
F Honnone deficiency sutes in males; gynecologic conditions t hat arc
responsive with anabolic steroids or chorionic metastatic
breast cancer in women; angioedema
44
Condition or Code
Prescription should have indicated on the
face either
The name of such condition OR
Specify t he code
C III - V medications can only be refilled
once if given more t han a 30 day supply
Refills
CIJI -V prescriptions
Maximum of 5 refills, expiring 6 months from date of
issue
Cannot be given no more than 7 days prior to t he
date t hat all previously dispensed supply would
have been used
Documentation
On back of original prescription must record
Date of refill
Quantity dispensed
Signature
Partial Fi lling - Cll
When partially filled for a terminally ill or
RHCF patient must :
Record on prescription "terminally ill" or
"RHCF patient" AND
Date, quantity dispensed, quantity remaining
and signature
Remaining quantity must be dispensed
within 30 days from the date written
5/ 22/ 2013
Facsimile of Schedule II
Permit ted for:
Pat ient enrolled in hospice program
Patient residing in Residential Health Care Facility
(RHCF)
May be transmitted provided
Hospice program of RHCF is licensed or approved by
Department
Dispensing pharmacy has a wri tten contract wit h
hospice program ofRHCF
Practitioner notes that patient is "hospice patient" of
"RHCF patient"
Cover delivered within 72 hours
Partial Filling - Cll
May partially fi ll CII provided t hat :
Pharmacist does not have suffi cient quantity t o
fill in its entirety
Must fill remai ning within 72 hours
The patient is a resident in a Residential
Health Care facility ( RHCF)
The patient has been diagnosed as being
terminally ill
Partial Filli ng- Clll - V
May partially fill CIII-V prescription
provided t hat:
Each partial fill is recorded in the same manner
as a refill
Total quantity dispensed does not exceed total
quantity prescribed for 30 day period
45
Must be enclosed wit hin a suitable and
durable container t o which is affixed in
such a manner as to prevent removal and
orange label upon which is indelibly typed,
printed or otherwise legibly written
Orange label
Such container shall be identified as a
controlled substance by either:
an orange label;
a label of another color over which is
superimposed an orange transparent adhesive
tape; or
an auxiliary orange label affixed to the front of
such container and bearing the legend,
prominently marked or printed "Controlled
Substance, Dangerous Unless Used As Directed"
Document ation
Information filed with the depart ment shall include but not limited
to:
Pharmacy prescription number
Pharmacy's Nationalldrntification Number
Patientname
Address, DOB, sex
Date filled
Quantiry
NOC
Numberof dayssupply
Prescriber's DEA
Da[e written
Serial number
Payment method
Numberofrefollsauthorized (CI II-V)
Refill number (CIII-V)
5/22/2013
Patient's name and address
If for pet - spies ohnunal and 1\ifl'M: and addU$$ of owner
Name, address. phon of pharmacy
Specific directions for use as stated on prescription
Name of prescriber
Legend prominently printed in ei ther boldface of upper case
lettering:
"CONTROLLED SUBSTANCE. DANGEROUS UNLESS USED AS DIRECTED
drug to any person other
Prescription number
Date of fi lling
Name of drug
Documentation
Filling pharmacist must record on face of
ONYSRx
Signature
Date of fi ll ing
Prescription number
Must be retained for a period of s years
Prescription information shall be fil ed
electronically with the Bureau of Narcotic
Enforcement no later than the 15'h of the next
month***
Filing of Prescripti ons
Written prescriptions must be filed in 3
separate fi les:
CII
Clll-V
Non-controlled prescriptions
Medical devices placed in non-controlled
file
Benzodiazepines are placed in the CIII-V
file
46
Out-of-State Prescriptions
May dispense to patient based on out-of-
state prescription for a CS as long as the
prescription is within 30 days of the date
written and all requirements required by
NYS
Will be dispensed in conformity with NYS
law and regulations
VA Facility Prescriptions considered as out-
of-state
Ordering
Power of Attorney
Must be signed by the same person who
signed the most recent application for
registration or renewal as well as the
person being authorized to obtain and
execute Official Order forms
Filed as readily retrievable record
5/22/ 2013
Record Keeping
Records of all transactions concerning CS are to
be kept for a period of 5 years from date of
transaction
Shall be readily available and promptly produced
for inspection and copying
Shall be maintained on premises where the
licensed activity is conducted
Records required as evidence of a violation shall
be released to authorized representatives of BNE
upon request and upon furnishing a receipt
DEA Form 222
Used for legal distribution or t ransfer ofCI
and II substances
May be obtained only by persons who are
registered with the DEA
Must be signed by t he same person who
signed the most recent DEA registrat ion or
by a person who is designated by a power
of attorney
Executing Form 222
All copies are prepared simultaneously
Typewriter, pen or indelible pencil
Only one item entered per line
Multiple units of the same finished or bulk form
and quantity of the same substance may be
ordered as one item
Total number of items ordered should correspond
to the number of li nes fi lled
Name and address of supplier (1 per form)
Signed and dated by authorized person
47
Executing Form 222
Copies 1 and 2 are sent to supplier and
Copy 3 is retained by purchaser
Upon receipt of items, record number of
containers received and date on Copy 3
Copy 1 is retained by supplier and Copy 2 is
sent to regional administrator of the DEA
Filling Order Forms
A pharmacy ("dispenser") may act as a "supplier" when:
Returning unused, partial, or full containers to a
manufacturer or distributor
Example: a pharmacy returns expired bottles of
Percocet. The pharmacy would have copied 1 and 2.
of t he 222 form. The date and containers shipped
are recorded by the pharmacy on the form. Copy 1 is
kept by the pharmacy, copy2 is sent to DEA.
Distribution to another practitioner
Example: to a physician for his oflke practice OR another
pharmacy
Destruction
5/22/2013
Lost or Stolen Forms
If unfilled order form is lost , execute new form, note
serial number of lost form, dat e lost, and the fact t he
substances were not received
lfforms are lost or stolen, notify Special Agent in
Charge of the DEA in the Division Office and provide
serial number of each form that is missing.
If an entire book of forms is lost and the serial numbers are
unknown, must report the date or approximate date of
issuing.
If forms are then found, must notify DEA to let them know
Controlled Substance Ordering
System (CSOS)
Provides an electronic equivalent to Form 22.2
Only allowance for electronic ordering of
schedule I and II
May order Clll - V, as well as non-controlled
substances
CSOS has no line item limit for a single order.
Contain the same i dentification information as
DEA 222 forms. Timely validation by the supplier.
Reduced number of ordering errors and l ower
t ransaction cost
Destruction of CS
Pharmacies may request to destroy
damaged, outdated or unwanted controlled
substances
Complete DEA Form 41
Prepare letter proposing date and method of
destruction, listing names of at least 2 people who will
witness the destruction
Wi tness should be a licensed physician, pharmacist,
mid-level practitioner, nurse or state local law
enforcement officer
Submit at least 2 weeks prior to destruction
48
Destruction of CS
DEA will notify registrant in writing of its
decision.
Upon destruction, signed copies ofDEA
Form 41 must be sent to DEA
Good practice for pharmacist to contact
environmental authorities to ensure
avoidance of any possible hazards
Destruction of CS
When a distributor destroys substances,
they are responsible for submitting a DEA
Form 41 to the DEA upon destruction.
A Form 41 need not be used b/t pharmacy and
disu-ibutor
DEA authorization to destroy controlled
substances is not needed when a state law
enforcement authority or member of a
regulatory agency witness the destruction
Record keeping
Maintain written records by supplier
Name, address, registry number of person
making return
The name, form and quantity of the substance
returned
The date the substance was received
5/22/2013
Destruction of CS
As an alternative, a pharmacy may forward
controlled substances to a DEA-registered
distributor who will dispose of the drugs
Distributor must issue a DEA 222. form to
the pharmacy. For schedule III-V, the
pharmacy should document in writing the
drug names, dosage forms, strength,
quantity, and date transferred
Record keeping
Maintain written record by disposer:
Date of return or dest ruction
Name, form, quantity
Name, address, registry number of person
making return
Name, address, registry number of supplier or
manufacturer to whom the substances are
returned or the name and license number of
persons performing witnessing the destruction
Inventory
49
Inventory
Complete and accurate list of all stocks and
forms of controlled substances on hand
Actual physical count
All inventories must be maintained at
registered location in a readily retrievable
manner
Biennial Inventory
As of May 1, 1975 and every two years
t hereafter, prepare and maintain an
inventory of all controlled substances
Actual physical count must be made
CIII, IV and V- an estimated count may be
made
Actual count has to be made if container holds
more than 1000 units and has been opened
Theft or Loss of CS
Upon discovery immediately notify nearest
DEA office and local police
Complete Form 106
Must contain the name and address of firm,
DEA registration number, date of theft, local
police notification, type of theft (ie: armed
robbery), any specific pharmacy container
marldngs, and a list of what is missing
Keep original copy, forward remaining z. copies
t o DEA Diversion Field Office
5/22/2013
Initial Inventory
CFR requires inventory include:
Inventory date
Time the inventory is taken
Drug name
Drug strength
Drug form
Number of unit s/ volu me
Total quantity
Recommended
Name, address, DEA registration
Signature of person taking inventory
Inventory
VVhen a drug not preciously controlled is
scheduled, the drug must be inventoried as
of t he effective date of scheduli ng
I-STOP
Impact on Pharmacy Practice in NYS
50
Prescription Drug Abuse
This is the nation's fastest growing drug
problem.
It has been classified as an epidemic by the
Centers for Disease Control and Prevention (CDC)
From 1995 to 2005 the number of Americans
abusing controlled prescription drugs jumped
from 6.2 to 15. 2 million
Americans consume So% of the global supply
of opioids and 99% ofhydrocodone.
Sources of Prescription Drugs
.. r.occtll i\1

: 0.., ,._
.........
.............. l-('O :J't.-
New York State
. . ri
..
5/22/2013
National Survey on Drug Use and
Health (NSDUH}
In 2009 nearly one-third of 12
years who used drugs for the first time
began by using a prescription drug non-
medically.
Emergency department visits involving
misuse or abuse of prescription drugs
increased 98-4% between 2004 and 2009.
In 20114.5 million persons .?,12 years and
older were nonmedical users of pain
relievers.
New York State
The number of all narcotic painkillers has
increased from 16.6 million in 2007 to
nearly 22.5 million prescription in 2010.
Since 2007 prescriptions for hydrocodome
increased 16.7% and oxycodone increased
82%.
__ ..... _ ..___...,_
..... . , .... .._ ..........
Signed into law by Governor Cuomo on August 27, 2012
I STOP
Chapter 447 of the laws of 2012
51
Purpose
Promote the safe and effective use of prescription
drugs and curb the diversion and abuse
Part A- Creating the Prescription Monitoring Program
and Enacting the Internet System for Tracking Over-
Prescribing
Part B- Requiring the use of Electronic Prescribing
Part C- Updating the State's Controlled Substance
Schedules
Part D - Continuing Education for Practitioners and
Pharmacists
Part E- Establish a Safe Disposal Program for Unused
Medications
Part A- Section 2
Adds new Public Health Law (PHL) 3343-
a
Prescription monitoring program registry. 1.
Establishment of system. (a) The commissioner
shall, in accordance with the provisions of this
section, establish and maintain an electronic
system for collecting, monitoring and
reporting information concerning the
prescribing and dispensing of controlled
substances, to be known as the prescription
monitoring program registry.
Patient Registry- Required
Information
Patient's name
Residential address
Date of bi rth
Gender
Date Rx issued
Date Rx Dispensed
Metric quantity of controlled substance dispensed
Number of days supply of the control dispensed
Name of prescriber
Prescriber's DEA number
Name of NDC of drug dispensed
Method of payment
5/22/ 2013
Prescription Monitoring Program
Part A
Patient Registry
The registry shall include all patient specific
information covering a period of time deemed
appropriate and feasible but no less than 6
months and no more than 5 years.
It shall be secure, easily accessible by
practitioners and pharmacists, and compatible
with e-prescribing of controls.
Requires DOH to establish protocols
necessary to protect information contained in
the PMP.
Duty to Consult- PHL 3343-a{ 2)
Every practitioner shall consult the
prescr iption monitoring program registry
prior to prescribing or dispensing any
controlled substance listed on schedule II,
III or IV of PHL 3306 for the purpose of
reviewing a patient's controlled substance
history with certain exceptions
52
Authority to Consult- PHL 3343-a(3}
Provides authority for pharmacists,
pharmacist interns, or his/her designee to
access the PMP registry.
Designee MUST be employed by the same
pharmacy or under contract with the
pharmacy.
Pharmacist consultation IS NOT
MANDATORY!
Guidance- PHL 3343-a(S)
Requires the Commissioners of DOH and
Education to provide guidance t o
practitioners and pharmacists and
pharmacies on the purposes and uses of the
PMP registry including availability of
educational information.
Analysis of Data - PHL 3343-a(7)
Requires the DOH to analyze the PMP data
periodically to determine if any
information indicates that a violation of
law or breach of professional st andards
may have occurred
If necessary allows for notification of
appropriate entities
5/ 22/ 2013
Immunity- PHL 3343-a(4)
Provides immunity to practitioners,
pharmacists or designees acting reasonably
and in good faith from any civil liabilities:
Arising from any false, incomplete, or
inaccurate information submitted to or
reported by the registry
Failure of the system to accurately or timely
report such information
Individual Access- PHL 3343-a(6)
Authorizes individuals or their legal
guardians access to their personal
controlled substance records history.
The Department will provide Public
Awareness of this option
Funding- PHL 3343-a(8)
Requires the Commissioner to seek fundi ng
from the federal government or other
entities to support the operation of the
Registry.
DOG is prohibited from imposing fees on
practitioners, pharmacists, designees, or
patients.
53
Part A- Section 3
Amends PHL 3333 (4)
Requires "REAL TIME" ftling of controlled
substance prescription information to the
PMP registry pursuant to DOH regulations
DOH authorized to waive real time
requirement if and to the extent the
Commission of Health finds it warranted
Economic hardship
Technological li mitations
Other exceptional circumstances
Part A - Section 5
Renumbers PHL 3371 (2) and adds 2 new
provision:
defining who may access the Registry
If a crime related to the diversion of controlled
substances has been committee, DOH may
notifY the appropriate law enforcement agency
and provide any relevant information
Electronic Prescribing
Part B
5/22/2013
Part A- Section 4
Amends PHL 3371-(1)
Allows the DOH to disclose relevant
information about dispensed controlled
substances to:
To notifY a practitioner of relevant controlled
substance activity
To pharmacists
Attorney's General Medicaid Fraud Control Unit
Local health departments
Medical examiners and coroners
Individuals requesting own records
Part A- Section 7
Part A would take effect one year after
enactment (Au gust 27, 2013)
The Commissioner of Health and
Commissioner of Education would be
authorized to add, amend, or repeal any rule or
regulation necessary and take other action
necessary for the implementation of such
provisions on its effective date.
Mandatory E-Prescribi ng
On or before December 31, 2012 the
Commissioner shall promulgate regulations,
in consultation with the Commissioner of
Education, establishing standards for
electronic prescriptions for controlled
substances
Effective two years from that date (December
31, 2014) no person shall issue any prescription
in this state unless it is made electronically.
54
Electronic Prescript ion
An electronic prescription is created,
recorded, or stored by electronic means;
issued and validated with an electronic
signature; and transmit t ed by electroni c
means directly from the prescriber to a
pharmacist.
Facsimiles are excluded from the definit ion
of an electronic prescription AND requires
a manual signature
Section 1
Sr,ecifies t hat hydrocodone is also known as
dthydrocodeinone and updates classifi cati on of oripravine
Section 2
Adds to Schedul e II those formulations ofhydrocodone that
appeared on Schedule Ill (effect ive 2/23/2013)
Section 3
Requi re the Commission to establi sh minimum standards
for storage, reporting, ordering and record keeping of the
hydrocodone formufations added to new Schedule II
5/22/ 2013
Requirements for E-Rxs
Contain the electronic signature of the
prescriber
Shall be electronically encrypted to prevent
unauthorized access, alteration or use
Have the signat ure or initials of the
pharmacist or intern ent ered in the
pharmacy's records to indicate acceptance
of the prescription by the pharmacy
Cont rolled Subs tance Sc hedules
Part C
Section 4
Repeal Schedule ll(b)(6), which lists oripavine
Section 5
Add a new Schedule ll(c)(28) to list tapentadol
Section 6
Amend opening paragraph of Schedule JJ(d) to
clarify that the inclusion of salts and isomers
applies whenever such salts or isomers are possible
55
Section 7
Add a new Schedule ll(g)(3) to provide the chemical
designation of a precursor to fentanyl
Section 8
Amends Schedule ll(h) pertaining to anabolic steroids,
eliminating language describing purposes of such
substances
Section 9
Amend opening paragraph of Schedule lll(c) to clarify that
the inclusion of salts and isomers applies whenever such
salts or isomers are possible
Section 13
Correct a typographical error
Section 14
Add new Schedule(0(3) to tramadol to Schedule IV
Sect ion 15
Correct a typographical error
Se ction 16
Amend Schedule V(d) to add ezogabine and
lacosamide, which are depressants, to Schedule V
Requirements
Requires a report of the DOH
Commissioner (with Work Group
participation) regarding the development
of recommendations and model courses of
continuing medical education and other
training materials for licensed health care
professionals in the appropriate use of pain
medications.
Section 10
Amend Schedule III(e) to remove references to
hydrocodone
Section n
Amend Schedule Jll(f) t o clarify description of
dronabinol
Section 12
Amend Schedule IV( c) to add fospropofo l and
carisoprodol to Schedule IV
Part D
Training Materials
Educational and continuing medical
education requirements for practitioners
appropriate to address prescription pain
medication awareness among health care
professionals
Provides for continuing education
requirements for pharmacists related to
prescription pain medication awareness
Continuing education in palliative care as it
relates to pain management
5/22/2013
56
Safe Disposal Program
PartE
Institutional Regulations
Institution -Class 3
May purchase and store CS
For inpatient and outpatient use through a
registered pharmacy dispenser
CS may be distributed within the
institution to wards, floors, operating and
emergency rooms
Must be accompanied by an administration
sheet
5/22/2013
Safe Disposal
Establishes a DOH "Take Back" Safe
Disposal Program for controlled substances
Done through law enforcement agencies
Provide immunity for those individuals
bringing in controlled substances as it relates
to state laws on the possession and transport of
controlled substances
Institution -Class 3
Hospitals, veterinary hospitals, mental
hospitals, or similar facilities
Nursing homes and other facilities having
the services of a physician, registered
nurse, and pharmacist may qualify for a
class 3 license
Institution- Class 3
Administration of all CS shall be authorized by
written order except:
In an emergency situation
As required orders (prn) - must be rewritten every 72
hours if continued
Standing orders or specific CS orders to be
administered at specific times are must be rewritten
every 7 days if continued
EXCEPTIONS: patients with convulsive disorders or chronic
spasticity or attent ion deficit disorder in institutional setting
OR in RHCF of prisons - such orders shall be valid for 30 days
57
Institution - Class 3
CS dispensed by an outpatient department
pharmacy to patients or employees of the
institution
Shall be dispensed only pursuant to
prescriptions issued by an authorized
prescriber
Must follow all rules and regulations for CS
Institution - Class 3a
Emergency medical kits
CS from a sealed emergency kit may be administered
by an order from an authorized pract itioner
Pharmacy who supplied the kit must be notified wit hi n
24 hours if the kit has been unsealed, opened or
tampered with
May contain up to a 24 hour supply of a max of 10
different CS in unit dose packaging, no more than
three of which may be in injectable form
Must be secured in a stat ionary, double-locked system
or other secure method approved by the Department
Record keeping - Class 3 and 3a
With Substocks
Distribution Records
A requisition record for the substock t o be
distributed
A signed receipt for the substock when
delivered
An administration sheet for each substock of a
CII indicating
Nameof CS
Strength
Dosage form
Number of doses
5/22/2013
Institution- Class 3a
Nursing homes, convalescent homes, health
related facilities, dispensaries or clinics not
qualifying as institutional dispensers in license
class 3
May administer CS to patients only pursuant to a
prescription and fill ed by an outside pharmacy
EXCEPT
In emergency medical kits
If Class 3a instit utional dispenser is operated as
an integral and physical part of a Class 3 facility,
may be provided with bulk stocks of CS
Record keeping- Class 3 and 3a
With Substocks
Acquisition Records
Running inventory wit h
Type, strength, and quanti ty of each drug received
and its distributi on
Date of receipt and distribution
Names and address of vendors
Duplicat e copies offederal order forms for CJI
Recordkeeping- Class 3 and 3a
With Substocks
Administration Records
Administration sheet indicating
Date and hour of administration
Name of patient
Name of prescriber
Quantity admi nist ered
Balance on hand after administrati on
Signature of administering nurse
58
Record keeping - Class 3a
A daily running record of all prescriptions
received indicating:
Date
Name and quantity of CS
Name of prescriber
Name of patient
Name of pharmacy
Prescription number
Storage and Security - Reserve or Main
Stocks
Cl and II kept in following:
A GSA class 5 rated steel cabinet or equivalent sa fe - if
weigh <750 lbs it shall be bolted or cemented to floor.
Vault - walls, floor and ceiling sha ll not be less than 8"
of reinforced concrete
The doors shall contain a multiple position
combination lock, a relocking device or equivalent and
steel plate having thickness of at least 1.5"
CIII - V
Stationary, securely locked cabinet
Storage and Security - Patient Care
Units
Less than a 72 hour supply
May be stored with patient's other medications
in securely locked medication cart or other
approved storage unit
Clls may not be stocked in carts
More than a 72 hours supply
Same as working stock without a registered
pharmacy requirements
Recordkeeping- Class 3a
A separate administration record
indicating:
Date and hour of administration
Name and quantity of CS
Name of prescriber
Patient's name
Signature of person administering
Balance of CS on hand after administration
Storage and Security- Working
Stocks
Of a registered pharmacy
Cli- V
Dispersed throughout stock of noncontrolled drugs in a way
that obstructs t hefr or diversion
Kept in a stationary. securely locked cabinet
Without a registered pharmacy
Cl- IV
Stationay. double locked cabinet each having separate keys
cv
Stationary, securely locke:d cabinet
Storage and Security
For 3a dispensers who obt ain CS for
individual patients from an outside
pharmacy
Substances shall be safeguarded as described
for patient care units
5/22/2013
59
Storage and Security- Medication
Carts
Must be equipped with
Double keyed locks
Be anchored to floor or wall when not in use
Locked drawer system
Independent locking device
Access shall be limited to an indentified
individual at all times
Institutional Dispensing
ONYSRx not required for inpatient use
CS to be administered or dispensed for use on
premises only if have written order by a
practitioner
EXCEPTION: in emergency situation where a
physician determines it is necessary to transfer a
critically ill patient to another medical facility- may
dispense a single dose of CS to the medical attendant
accompanying the patient if the travel time is expected
to be >3 hrs
Restricted Distribution Programs
FILLING AND DISPENSING
MEDICATIONS
5/ 22/2013
Disposal of Controlled Substances
Single unit doses or partial doses remaining
after the administration or attempted
administration may be destroyed on
premises by a pharmacist or nurse if:
A notation is made on the administration sheet
Destruction is witnessed by a 2nd pharmacist,
nurse or other responsible person designated
by administrators
Institutional Dispensing
An institutional dispenser may dispense CS
for use off its premises only pursuant to a
prescription issued
EXCEPTION: pract itioner in an emergency
room hospital without a full-time pharmacy
and when services are not available: may
dispense to a patient up to a 24 hour supply in
an emergency situation.
STEPS Program
System for Thalidomide Education and Prescri bing Safety
Females must undergo pregnancy testing and use
effective birth control
Males must use condoms (even if vasectomy)
All prescribers and pharmacies must be registered
Use of drug is monitored by mandatory patient surveys
Prescript ions li mited to ~ 8 day supply wit h no refi ll s
Must be filled within 7 days of last pregnancy test if of
childbearing age, or 30 days for all other patients
Telephone Rx's are NOT allowed. Fax depends on state.
60
iPLEDGE
Male and female patients must register in
order to receive isotretinoin
Prescribers must be registered to prescribe
Pharmacies and wholesalers must be
registered to receive
iPLEDGE
Women of child-bearing age
Have a 7 day window from date written to fill
and pick up medication (first time)
Males and Women of non-child bearing
potential
Have 30 day window from date written to fill
and pick up medication
CARE Program
Plan B
Available without a Rx for patients<: 15 years
Available for patients < 15 years only with a Rx
No longer just stored in the prescription area (family
planning/ female health aisle}. Can be sold in an
establishment with an onsite pharmacy BUT the
pharmacy department does not have to be open when it is
sold
Proof of age is required upon purchase without a Rx
No ID ; No Sale
"Plan B is not recommended for routine use as a contracepti ve.
It is not effective in terminating an existing pregnancy
iPLEDGE
Requires monthly doctor visits for refills
Prescriber registers patient into iPLEDGE
database and provides a special identifying
code number
Pharmacist must check database prior to
fi lling
Other Restrictive Programs
Lotronex (Lotronex Prescribing Program)
Clozaril (Clozaril National Registry)
Tikosyn (T. I.P.S. Program)
Iressa (Iressa Access Program)
Xyrem (Xyrem Success Program)
Nexavar (REACH Program)
METHAMPHETAMINE ANTI-
PROLIFERATION
5122/2013
61
Combat Methamphetamine Epidemic
Act 2005
Update to the US Patriot Act
Restrict the sale of pseudoephedrine, ephedrine
and phenylpropanolamine (PPA)
Reclassification ofthtse ingredients as Schedule Listed Chemicals
Located wlu:re the purchasers do not have direct access befo1-e the
sale is made or locked in a display Cast'
Mai ntai n wrinen or electronic log of sales identifying item
purchased, quantity, name and address of purchaser, date and
time of sale (not requi red if single sales pack sold containing
s6omg of pseudoephedrine).
Purchaser must present a photo 10, sign the log
HYPODERMIC SYRINGES/NEEDLES
Written Prescriptions
Name, address and age of patient
Name, address, phone and signature of prescriber
Pharmacist shall record on face of prescription
Signature
Date of dispensing
Prescription valid for 2 years from dat e issued
Renewals should be recorded on reverse side with
the date, quantity and signature of pharmacist
5/22/ 2013
Combat Methamphetamine Epidemic
Act 2005
a Seller must directly transfer the product to the purchaser
Log must be maintained for least l years after the date of
entry
Sellers must provide, document and certify training of all
employees (written evidence sent t o DEAl
Limit sales to 9 grams of ephedri ne base, pseudoephedrine
or PPA base within a 30 days period or no more than 3.6
grams in any single day (regardless of number of
transacti ons)
Not more than 75 grams of the 9 grams purchased in each
30 day period may be acquired via the Postal Service
Hypodermic Syringes/Needles
It is unlawful for any person to sell or
furnish a syringe or needle except:
Pursuant to a written prescription
To persons who have been authorized by the
commissioner to obtain and possess
In an emergency, pursuant to an oral
prescription
Through the Expanded syringe access
demonstration program
Oral Prescriptions
Emergency situations
Reduce to writing indicating
Name, address and phone of prescriber
Patient name and address
Date
Quantity and di rection for use
Fact that it is a telephone order
Cannot exceed wo syringes/needles
62
Oral Prescriptions
Within 72 hours prescriber must deliver
prescription
If do not receive mark on oral script:
"Prescription not received", sign and date
Follow up should be attached to corresponding
oral prescription
Follow-up Rx
On face document signature, date of filling, Rx
number and follow-up
,. On back, stamp as ifCIII-IV
ESAP
Created to help prevent the spread blood
borne diseases by making access to
hypodermics and syringes easier for the
general public
Became effective Jan 1, 2001
ESAP
May only be sold in quant ities of10 or fewer to
persons 18 years of age or older.
May not advertise that hypodermic
needles/syringes are available for sale without a
prescription.
Must be stored in a manner that makes them
available only to authorized personnel and not
openly available to customers.
5/22/2013
Expanded Syringe Access Demonstration
Project
HYPODERMIC SYRINGES/NEEDLES
ESAP
Licensed pharmacies, health care facilities,
and health care practitioners who can
otherwise prescribe hypodermic needles or
syringes
Register with the NYS DOH to sell or furnish
up to 10 hypodermic needles or syringes to
persons 18 years of age or older.
Required to cooperate in activities that
promote safe disposal of used hypodermic
needles or syringes
ESAP
A safety insert must be pr ovided as part of
each transaction
The NYSDOH provides these brochures
No restrictions on the types of hypodermic
needles/ syringes
Fees or prices established by the provider
Third-party reimbursement is not available
when purchased without a prescription
63
Safety Insert
Contains at a minimum
Information on proper use
Risk of blood-borne disease that may result from use of
syringes and needles
Methods for preventing the transmission or
contraction of blood-borne disease
Proper disposal practices
Dangers of injection drug use and how to access drug
treatment
Toll-free number for info on HIV
Statement t hat it is legal for persons to possess
syringes
NYS PHARMACISTS AS
IMMUNIZERS
Pharmacists must be certified
Training course (within last 3 years)
Acceptable lO the Commissioner or associated with a
Doctor of Pharmacy degree
Possession of a current COA from another j urisdiction
and continuous practice
CPR certification
OSHA training
Register with NYS Board of Pharmacy
http://www.op.nysed.gov/pharmimmuncert.pdf
STANDING ORDER
Non-patient-specific order
prescribed or ordered by a licensed physician or
certified nurse practitioner with a practice site in the
county in which the inununization is administered;
or
if the immunization is administered in a county
with a population of75,000 or less, the
immunization shall be prescribed or ordered by a
licensed physician or certified nurse practitioner
with a practice site in the county in which the
immunization is administered or in an adjoining
county.
5/22/2013
PHARMACIST AS IMMUNIZERS
Part 63: 63.9
NYS PHARMACISTS AS
IMMUNIZERS
Influenza and
pneumococcal disease to
adults 18 years of age and
older
Also includes
administration of
medicarion 10 treat
anaphylaxi.<
Pharmacist or pharmacy
MUST have
a non-patient specific order
Patient specific order
Immunizing agents to
prevent herpes zoster
ONLY patient specific
order
WHAT THE STANDING ORDER
SHALL INCLUDE
Specific agents, dose, indications and routes
Name, license# and signature of prescriber
Can be pharmacist-specific or provided to
employer for certified pharmacists under
contract
Beginning and end date
64
NYS REGULATIONS
Ensure the patient has no contraindications
Have emergency anaphylaxis treatment
available at the location
Inform of potential side effects and adverse
reactions orally and in writing
Written instructions on what to do if
contraindications or adverse reactions -
MUST give the VIS
NYS REGULATIONS
Report adverse outcomes, if any according to
Federal Law (V AERS)
Provide information on the importance of having
a primary care provider
Report the administration of any immunizations
to the New York State Department of Health
and/or to the New York City Department of
Health and Mental Hygiene, in a manner required
by the Commissioner of Health.
ADMINISTRATION OF
IMMUNIZATIONS
FOR MORE INFORMATI ON
http:/ /www. op.nysed.gov /prof/ pharm/ pharmi
mmunizationfaq.htm
5/22/ 201 3
NYS REGULATIONS
With the consent of the recipient or a person
legally responsible when the recipient is
incapable of consenting, the certified
pharmacist shall communicate this information
to the recipient's primary health care
practitioner, if one exists, within one month of
the administration of such immunization, and
such communication may be transmitted in
electronic format
RECORD KEEPING
A certified pharmacist shall ensure that a
record of all persons immunized including:
Recipient's name
Date
Address of adminisrration
Administering pharmacist
Immunization agent
Manufacturer and lot number
Can be part of patient profile or separate file
Collaborative drug therapy
management
Education l aw: Article 137:6801-a
65
Collaborative Drug Therapy
Management
Demonstration project
Collaborative drug therapy management
The performance of services by a pharmacy
relating to the review, evaluation and management
of drug therapy to a patient who is being treated
by a physician for a specific disease or disease state
In accordance with a written protocol with a
voluntarily participating physician and with the
policies, procedures and protocols of the faciltiy
Facil ity
Teaching hospital, t r eatment center or
hospital- based outpatient department
Residential health care facilities and nursing
homes are excluded
Questions??
5/ 2212013
CDTM Protocol
Adjusting or managing a drug regimen of a
patient
Does not include substituting or selecting a
different drug
Ordering clinical laboratory tests
Ordering or performing routine patient
monitoring functions
Participating Pharmacist
Awarded either a
master of science in
clinical pharmacy or a
doctor of pharmacy
degree
Maintain a current
unrestricted license
Have a minimum of
three years experience
in a health facility
Awarded a bachelor of
science in pharmacy
Maintain a current
unrestricted license
Within the last seven
years, have a minimum
of three years
experience, of which at
least one year shall
include clinical
experience in a health
residency
References to Review
Laws, Rules & Regulations - State Board of
Pharmacy
http://www.op.nysed.gov/pharm.htm
Controlled substance Act (Article 33)
http://www. health. state.ny.us/ regulations/pub
lie health law/article/ 33/ docs/33odf
Controlled Substance Regulations (Part 8o)
hnp:/ /www.health.state.ny.us/regulations/ con
trolled substance/part/ 8o/docs/ 8o.pdf
66

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