District of Columbia
Department of Health
Health Regulation and Licensing Administration
Board of Pharmacy and Pharmaceutical Control
Patricia M. D’Antonio, RPh, MS, MBA,CGP
Executive Director, Board of Pharmacy
Program Manager, Pharmaceutical Control
September 28, 2013
Organization
• Health Professions Licensing Administration
– Board of Pharmacy
• Pharmacists
– Authority to Immunize
• Pharmaceutical Detailers
• Pharmacy Interns
• Pharmacy Technicians (Bill passed; regulations
pending)
Board of Pharmacy
• The mission of Board of Pharmacy is to protect
and improve the public health through the
efficient and effective regulation of the practice
of Pharmacy and Pharmaceutical Detailing;
through the licensure of Pharmacist,
Pharmaceutical Detailers and Pharmacy Interns.
• 7 Members
– 5 pharmacists
– 2 consumers (1 space vacant)
– Daphne Bernard, PharmD Chairperson
Pharmaceutical Control Division
• Health Regulation and Licensing
Administration – Division of Food, Drug,
Radiation and Community Hygiene
– Conduct routine and complaint driven
inspections of pharmacy operations of health
facilities
– Investigate reports of contaminated or
suspect drugs or improper distribution of
controlled substances
– Investigate unusual or suspicious reports in
drug supply or in the handling of the drug by
the professional
Regulated Facilities Include:
• Pharmacies
– Resident
– Non-Resident
• Researchers/Teaching
Institutions
• Wholesalers/Distributors/
Manufacturers
• Fire/EMS
• Medical Examiner
• Substance Abuse
Treatment Programs
• Animal Clinics
• Dialysis Centers
• Ambulatory Surgical
Centers
• Controlled Substance
Registration for
Professionals
Liaison Role
Between District and Federal entities:
• Food and Drug (FDA)
• Drug Enforcement Administration (DEA)
• Health Human Service (HHS)
• Consumer Protection Agency
• And others involving regulatory
control matters related to medications
Pharmacy Law and Regulations
• DC Code Title 47, Section 2885.01
Pharmacy
• DC Code Title 48, Section 701-901
Pharmacy related laws
• Federal Law
– Code of Federal Regulations (CFR) 21, Part 1
• Section 1300 - Drugs
Pharmacy Law and Regulations
• DCMR Title 22 Public Health & Medicine
Chapter 4 – Distribution, Manufacturer, or Wholesaler of
Drugs
Chapter 5 – Safe Disposal of Medications
Chapter 10 – Controlled Substance Registration for
Manufacturers, Distributors, and Dispensers
Chapter 12 – Controlled Substances
Chapter 13 – Prescription and Distribution
Chapter 15 – Inspections
Chapter 19 – Pharmacies
Laws/Regulations
• DCMR Title 17 Business, Industry
Professions
– Chapter 40 – Health Occupations, General
Rules
– Chapter 41 – Health Occupations,
Administrative Procedures
– Chapter 65 – Pharmacists, Pharmacy Interns
– Chapter 83 – Pharmaceutical Detailers
– Chapter 85 – Criminal Background Check
Other Regulations of Interest
Title 22 DCMR
Chapter 20 – Hospital and Clinics, Pharmacy Services
Chapter 31 – Health Care and Community Residence
Facilities
Chapter 32 – Nursing Facilities, Pharmaceutical
Services
Chapter 35 – Group Homes
Where can I find this?
• DC Municipal Regulations and DC
Register www.dcregs.dc.gov
– Subscribe
– My favorites
• DC Board of Pharmacy webpage
– http://doh.dc.gov/bop
• DC Pharmaceutical Control webpage
– http://doh.dc.gov/pcd
What’s New?
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Criminal Background Check
Immunization Updates
Safe Disposal of Unused Pharmaceuticals
Collaborative Practice
Pharmacy Technician
Prescription Drug Monitoring Program
Criminal Background Check
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As of January 3, 2011
Initial, renewal or reinstatement license
All health care professionals
FBI and Local
Repeat every 4 years
Through Morpho Trust Services
In District/Out of District Process
http://doh.dc.gov/cbc
Immunization
• 17 DCMR Section 6512
• Effective, June 8, 2012
• immunize patients twelve (12) years and
older with parental consent or patients
eighteen (18) years and older that present
valid identification for specific vaccinations
by protocol
Immunization
• Obtain written protocol for the vaccinations from
a physician
• Report vaccine administration to the physician
listed on the Vaccination Protocol and to the
patient’s primary care physician.
• Adverse events reporting requirements
– Pharmaceutical Control Division
– Director of the Department of Health
– within 48 hours of the discovery of occurrence
Immunization
• Hepatitis
• Shingles
• Human
Papillomavirus
• Tetanus
• Tdap
• Meningococcal
• Heamophilus
Influenzae
• Pneumococcal
• Influenza including
but not limited to
H1N1 and other
epidemic vaccinations
specified by the World
Health Organization
or the Center for
Disease Control at
the time of
vaccination
Immunization
• Registration with the Board required
– not new but seems to cause confusion
– FAQs on Board of Pharmacy website
– Pharmacist License not Facility License
Safe Disposal of Unused
Pharmaceuticals
• Unused Pharmaceutical Safe Disposal Act of
2009 (legislation)
• Applies to Health Care Facilities
• Facilities shall not disposed of unused
pharmaceuticals by flushing the product
down a drain or any method that uses the
public sewer system
Safe Disposal of Unused
Pharmaceuticals
• Subject to a civil fine of up to one
thousand dollars ($1,000) per occurrence;
and
• Required to submit to the Board of
Pharmacy, or its designee, a mitigation
plan designed to prevent further such
occurrences within thirty (30) days of
receipt of a request for the mitigation plan
Collaborative Practice
• Collaborative Care Expansion Amendment
Act of 2012 passed in May 31, 2013
• Regulations pending from Board of
Pharmacy and Board of Medicine
• Voluntary written agreement
• Between a licensed pharmacist and a
licensed physician or another health
practitioner with independent prescriptive
authority
Collaborative Practice
• Defines the scope of practice between the
licensed pharmacist and licensed
physician, or other health practitioner,
– Licensed by a District health occupation board
• Initiation, modification, or discontinuation
of a drug therapy regimen
Collaborative Practice Agreements
• Specification of the drug therapy to be provided
and any tests that may be necessarily incident to
its provision;
• Conditions for initiating, modifying, or
discontinuing a drug therapy; and
• Directions concerning the monitoring of a drug
therapy and the conditions that would warrant a
modification
• Establish policies and procedures for approving,
disapproving, and revoking collaborative
practice agreements.
Pharmacy Technician
• Pharmacy Technician Amendment Act
– Passed July 19, 2013
• 17 years of age
• A high school diploma or its equivalent, or
has passed a Board-approved
examination that proves that he or she has
achieved competency in the educational
skills required to perform the function of a
pharmacy technician; and
Pharmacy Technician
• A current certification from the Pharmacy
Technician Certification Board, the National
Health Career Association, or another national
or state certifying organization approved by the
Board; or
• Successfully completed one of the following
types of pharmacy training programs, which
shall include a Board-approved exam:
Technician Training Programs
• (i) A national, regional, or state accredited pharmacy technician
training program recognized by the Board;
• (ii) A pharmacy technician program at a college or university that is
accredited by an accrediting body recognized by the Secretary of
the United States Department of Education or the Council on
Postsecondary Accreditation
• (iii) An employer-based pharmacy technician training program
recognized by the Board that includes within a one-year period a
minimum of 160 hours of training, including theoretical and practical
instruction; or
• (iv) A pharmacy technician program that meets the guidelines of the
American Society of Health-System Pharmacists, is licensed by the
District of Columbia Educational Licensure Commission, and has
certified to the Board its intent to pursue accreditation upon
becoming eligible to do so.
Pharmacy Technician
• Grandfather Clause
• Defines the roles of ancillary personnel
• Addresses supervision responsibilities of a
pharmacist
• Regulations pending Board of Pharmacy
– Legislation provides one year
– Monitor communications and DC Register for
Proposed Regulations
Prescription Drug Monitoring Program
• Tool for practitioners to review prior to
writing controlled substance prescription
• Legislation introduced in 2012
• Hearing held in July 2013
• Expected passage by end of 2013
Findings on Inspection
• Failure to document administration and/or
wasting of CSII substances
• Failure to obtain drugs from an approved
supplier
• Failure to conduct CSII audit as indicated
• Medication Administration Records (MARs) not
consistently reflecting current date and time
• Physician signature log missing DC Controlled
Substance and DEA numbers and respective
expiration dates
Compounding
• preparation, mixing, assembling,
packaging, or labeling of a drug or device
• result of a practitioner’s prescription drug
order or for the purpose of, or as an
incident to, research, teaching, or chemical
analysis and not for sale or dispensing
• in anticipation of prescription drug orders
based on routine, regularly observed
prescribing patterns
Manufacturing
• prepare, produce, propagate, compound,
convert, process, or package a drug,
either directly or indirectly, by extraction
from a substance of natural origin, or
independently by means of chemical
synthesis
Manufacturing
• any packaging or repackaging of the
substance or drug; labeling or relabeling of
any drug package or container to further
distribution from the original place of
manufacture to the person who makes
final delivery, distribution, or sale to the
ultimate consumer or user
AccessRx
Prescription Drug Marketing
Costs
• manufacturers and labelers of prescription
drugs who engage in marketing in District
report their costs for pharmaceutical drug
marketing in the District
• 2011 report $83.7M (158 companies)
• Impact Reports
– Antipsychotic Use in Children (2012)
– Antipsychotic Use in the Elderly (2013)
Future
• Clarification of Student Intern
requirements
• Prescription Drug Monitoring Program
• Manufacturer/Distributor Regulations
• Compounding Regulations
Board of Pharmacy Meeting
First Thursday of every month
9:30am
899 North Capitol Street, NE
2nd Floor Conference Room
Open to the Public
Health Regulation and Licensing Administration
Board of Pharmacy and Pharmaceutical Control
899 North Capitol Street, NE
2nd Floor
Washington DC 20002
Phone Number:
202-727-9856
patricia.dantonio@dc.gov