Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Friday, April 1, 2016
New Jersey Board of Pharmacy Reminds pharmacists: "The compounding of domperidone without utilizing FDA’s Expanded Access IND program is a direct violation of Board regulations N.J.A.C. 13:39-7.5, N.J.A.C. 13:39-6.2(f)(9), and N.J.A.C. 13:39-4.18(a) and may result in the Board imposing disciplinary action against pharmacies and pharmacists participating in this unauthorized activity."
Compounding of Domperidone
It has come to the Board’s attention that some pharmacists
may be compounding domperidone. According to
FDA, domperidone is currently not approved for human
use in the United States. Although there are restrictions
on domperidone, FDA recognizes that there are patients
with severe gastrointestinal motility disorders refractory to
standard treatment who might benefit from domperidone
and in whom the benefits of the drug may outweigh its
risks. Domperidone is currently available to these patients
through FDA’s Expanded Access to Investigational New
Drug (IND) program. This Expanded Access IND program
ensures that the appropriate safeguards are in place to
protect patients treated with domperidone from the drug’s
serious adverse effects, including QT prolongation and
cardiac arrhythmias. Information on this Expanded Access
IND program can be found at http://www.fda.gov/Drugs/
DevelopmentApprovalProcess/HowDrugsAreDeveloped
andApproved/ApprovalApplications/InvestigationalNew
DrugINDApplication/ucm368736.htm.
The compounding of domperidone without utilizing
FDA’s Expanded Access IND program is a direct violation
of Board regulations N.J.A.C. 13:39-7.5, N.J.A.C.
13:39-6.2(f)(9), and N.J.A.C. 13:39-4.18(a) and may
result in the Board imposing disciplinary action against
pharmacies and pharmacists participating in this unauthorized
activity.
source New Jersey Board of Pharmacy April 2016 Newsletter
source New Jersey Board of Pharmacy April 2016 Newsletter
Oklahoma Board of Pharmacy takes action against pharmacists for problems relating to compounding and 797
David Kent Johnson, DPh #13429 – Case No. 1377: Agreed
to guilt on 1,887 counts; neither admits nor denies guilt on
five counts including failing to supervise all employees as
they relate to the practice of pharmacy; failing to comply
with all aspects of USP compounding standards; failing
to mix, prepare, and otherwise manipulate, count, crush,
compound powders, or pour liquid hazardous drugs inside a
ventilated cabinet designed to prevent hazardous drugs from
being released into the work environment; failing to verify
all critical processes; failing to ensure appropriate stability
evaluation is performed; failing to have available written
policies and procedures for all steps in the compounding
of preparations; failing to train and evaluate staff by
using media-fill challenge tests to evaluate sterile technique;
compounding a drug preparation that is commercially available
in the marketplace or that is essentially a copy of an
available FDA-approved drug product; failing to use total
aseptic techniques; failing to establish procedures for sterilization
of all preparations compounded with any nonsterile
ingredients; failing to test all high-risk level compounded
sterile preparations (CSPs) for administration by injection; failing to establish procedures for semiannually testing the
techniques of pharmacists using simulated aseptic procedures;
failing to have a controlled limited access area that
has a certified and inspected ISO Class 5 environment that
is inspected and certified semiannually; failing to routinely
inspect, calibrate as necessary, and check to ensure proper
performance of automated, mechanical, electronic, limited
commercial scale manufacturing or testing equipment;
failure to use USP–NF drug substances and inactive components
that have been made in an FDA-registered facility;
failure to have written procedures for the compounding of
drug preparations to ensure that the finished preparations
have the identity, strength, quality, and purity they purport
to have; failing to assign the correct BUDs for CSPs; and
failing to maintain a ratio of no more than two pharmacy
technicians per supervising pharmacist on duty. Five
years’ probation until December 3, 2020, and $5,000
fine. Shall attend an eight-hour law seminar in addition
to the required 15 hours of CE during the calendar
years 2016 and 2017. All 15 hours of required CE that
respondent must have to renew his license shall be live
during his five years of probation. Respondent shall
provide documentation of recently completed training
in compounding under USP <797> guidelines. Respondent
shall attend and provide the Board with proof of
biannual training under USP <797> guidelines for five
years until December 3, 2020.
source Oklahoma Board of Pharmacy April 2016 Newsletter
source Oklahoma Board of Pharmacy April 2016 Newsletter
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