Missouri Board of Pharmacy Issues Sterile Compounding Board Advisory

Sterile Compounding Board Advisory
The Board recently issued a Sterile Compounding Board Advisory for all compounding pharmacies. The advisory contains important information for all compounders. The advisory is available for review  here

Missouri Board of Pharmacy HB 412 Veterinary Pharmacies Rules

HB 412 IMPLEMENTATION FAQ
(Veterinary Pharmacies)
During the recent 2011 legislative session, the 96th Missouri General Assembly enacted House Bill 412 which requires a Missouri pharmacy permit for facilities or entities dispensing legend drugs for animal use by prescription/veterinarian order. This FAQ provides general information on complying with the new law which becomes effective on August 28, 2011. The Board’s goal is to educate the public regarding the new requirements and to assist in compliance.
FAQ
1)
Who needs a pharmacy license?
Effective August 28, 2011, any facility or entity selling or dispensing legend drugs for animal use by prescription/order must have a Missouri pharmacy permit. The new law does not apply to drugs that can be dispensed without a prescription/veterinarian order.
2)
Does HB 412 apply to all animal drugs?
No. The new law only applies to drugs that require a prescription/veterinarian order for animal use. Many veterinary antibiotics and vaccines can be dispensed over-the-counter without a prescription/order. The new law does not apply to over-the-counter products. Review the product label or check with your local veterinarian to determine if a prescription/veterinarian order is required for products in your inventory.
3)
What is a “legend drug”?
A “legend drug” is specifically defined in 21 USC §353 of federal law. As a general guide, the term applies to any drug that includes, or is required to include, one of the following cautionary statements on the label:

“Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian”

“Rx only”

“Caution: Federal law prohibits dispensing without a prescription”
Generally, products labeled “For Veterinary Use Only” do not require a prescription/veterinarian order. A pharmacy permit is not required to dispense or sell these products although other law/restrictions may apply.
4)
Does HB 412 apply to over-the-counter drugs?
No. HB 412 does not apply to over-the-counter products that can be sold without a prescription/order.
5)
What about antibiotics/vaccines?
Under federal law, many antibiotics and vaccines may be dispensed to animals without a prescription/order. HB 412 does not apply to antibiotics or vaccines that can be lawfully sold without a prescription/order. Review the product label or check with your local veterinarian to determine if a prescription/order is required.
6)
What about medicated animal feed?
Medicated animal feed does not fall under the definition of a legend drug. HB 412 does not apply to medicated animal feed.
7) What about animal devices?
HB 412 only requires a permit if you are providing legend drugs by prescription/order. The law does not
apply to the sale of devices.
8) How does the new law affect drugs dispensed by a veterinarian?
HB 412 does not restrict or apply to drugs dispensed by a veterinarian to his/her patients.
9) What type of pharmacy permit do I need?
Facilities may apply for a Class A (Community Ambulatory) pharmacy permit or a Class L (Veterinary
Pharmacy) permit. Class A pharmacies must have a Missouri licensed pharmacist present on site when
legend drugs are dispensed, sold or filled. Class L pharmacies will be authorized to operate and dispense
non-controlled drugs in the absence of a pharmacist as allowed by HB 412 and the Board’s rules.
However, Class L pharmacies may dispense legend drugs for animal use only and cannot dispense drugs for
human use.
10) If I have a Class A permit, do I need to add a Class L?
No. Class A pharmacies can dispense legend drugs for animal use under their current permit.
11) What are the requirements for a pharmacy permit?
To be licensed as a pharmacy, applicants must generally meet the following requirements:
 The pharmacy’s equipment and facilities must be operated and maintained in a manner that will
not endanger the public health or safety;
 The pharmacy must be equipped with proper reference materials and pharmaceutical and sanitary
appliances;
 The pharmacy must be under the supervision of a registered pharmacist (designated as the
pharmacist-in-charge);
 The pharmacy must be clean, sanitary and orderly. For Class L (Veterinary) permit applicants,
areas where legend drugs are stored or maintained must be clean and sanitary, and;
 The pharmacy must be operated in compliance with all applicable laws, including, all pharmacy
and drug distribution laws and regulations.
For additional permit information/requirements, see the following statutes/rules: § 338.220, § 338.140, §
338.250, 20 CSR 2220-2.010 and 20 CSR 2220-2.020.
12) How do I apply for a pharmacy permit?
Pharmacy permit applications are available online at http://pr.mo.gov/pharmacists-forms.asp. Permit
applications may be filed now. The application fee is $ 300.
13) What about pharmacies located outside of Missouri?
Pursuant to 20 CSR 2220-2.025, non-resident pharmacies shall not ship, mail or deliver prescription drugs
into Missouri without first obtaining a Missouri pharmacy permit. This includes prescription drugs for
animal use. Non-resident permit applications/forms are available online at
http://pr.mo.gov/boards/pharmacy/375-0492.pdf.
14) Does a pharmacist have to be on site?
 Class A Pharmacies: Under 20 CSR 2220-2.010(1)(B), Class A pharmacies must have a licensed
pharmacist present on site when any legend drug is compounded, dispensed or sold. Additionally
pharmacy technicians must be under the direct supervision of a Missouri licensed pharmacist.
 Class L Pharmacies: Under HB 412, Class L pharmacies are not required to have a pharmacist on site if
a Missouri licensed pharmacist reviews the pharmacy’s activities and records, as authorized by HB 412
and the Board’s rules. As a result of the new law, pharmacy technicians in a Class L pharmacy may
only dispense or sell non-controlled medications without a pharmacist present if a Missouri licensed pharmacist performs the review required by the Board’s rules. At this time, the Board is in the process of promulgating rules. Note: A Missouri licensed pharmacist must be present on site of a Class L pharmacy whenever legend drugs are compounded for animal use or if the pharmacy sells or dispenses controlled substances.
15)
Will my staff need to be licensed/registered?
A Missouri pharmacy technician registration is required for any person who “assists in the practice of pharmacy.” Generally, technician registration will be required for:

Any person who routinely has independent access to prescription only drug products;

Any person who assists the pharmacist in the practice of pharmacy. This may include, but is not limited to, staff or personnel that may take prescription orders over the phone, and;

Any person that sells or dispenses prescription legend drugs.
For more on Missouri’s pharmacy technician requirements, see § 338.013 and 20 CSR 2220-2.700. For technician application requirements/forms, visit the Board’s website at http://pr.mo.gov/pharmacists-forms.asp.
16)
When will the Board promulgate rules for Class L pharmacies?
The Board is in the process of promulgating rules to implement HB 412. The Board anticipates filing the rules on or before September 1, 2011 (this date is tentative and subject to change). To receive future rule updates via e-mail, register for the Board’s e-alerts at http://pr.mo.gov/pharmacists-newsletter.asp. Rule updates will also be posted on the Board’s website.
17)
Who should I contact with questions?
You may e-mail the Board at pharmacy@pr.mo.gov or you may contact the Board office at (573) 526-6985. You may also contact the Board’s pharmacy inspector for your area. Inspector contact information is located on the Board’s website at http://pr.mo.gov/boards/pharmacy/territoryassignment.pdf.
Interested parties should review HB 412 as well as Chapter 338, RSMo, and the Board’s rules in their entirety to ensure compliance with Missouri law. The Board’s rules/statues are available online at http://pr.mo.gov/pharmacists.asp. The full text of HB 412 is available at http://www.house.mo.gov/billtracking/bills111/billpdf/truly/HB0412T.PDF

Missouri Board of Pharmacy has Launched New Patient Safety Campaign

Board Launches New Patient Safety
Campaign
A Message from the Board President
For over 100 years, the Missouri Board of Pharmacy has
served the public by ensuring the safe regulation of pharmacy
practice in Missouri. Public protection is the Board’s
primary mission and in the forefront of all that the Board
does. In line with this mission, the Board is pleased to announce
its 2013 MoSafeRx patient safety campaign.
The goal of the MoSafeRx campaign is to promote a
culture of patient safety in all pharmacy practice settings.
According to the United States Agency for Healthcare Research
and Quality (AHRQ), more than 777,000 injuries
and deaths are caused each year by adverse drug events.
Health care costs for treating these patients are estimated
to be anywhere from $1.56 billion to $5.6 billion a year.
Now more than ever, it is important that the Board joins
the crucial discussion on ways to increase patient safety in
the pharmacy profession. Board licensees are usually the
last ones to interact with a patient before a prescription is
dispensed. The decisions we make can change lives.
As a licensed and practicing pharmacist for over 22 years,
I know the busy demands of pharmacy. However, I also know
how important it is to protect our patients. Patient safety is
more than just providing the right drug and the right dose
to the right person. Instead, it is a daily commitment to
protecting our patients in everything we do.
Visit the Board’s Web site at http://pr.mo.gov/pharmacists
for more information on the MoSafeRx campaign. The Web
site contains a variety of patient safety tools and resources,
including the following:
♦♦ Consumer brochures are available in English and Spanish
on a variety of patient safety topics, including how
to use medication safely and how to safely store and
dispose of unwanted medicine. A “Personal Medication
List” is also available to assist patients with recording
their medications.  ♦♦ The video “Medication Safety: A Patient’s Perspective”
provides a sharp reminder of how medical errors can
permanently change lives.
♦♦ March 2013 is National Patient Safety Month. Check
the Board’s Web site in March for additional information
on National Patient Safety Month activities sponsored
by the Board.
♦♦ Free patient safety continuing education courses
geared specifically for Missouri licensees (dates to be
announced).
♦♦ Food and Drug Administration patient safety videos and
practice resources made specifically for pharmacists
and pharmacy technicians.
Do not know where to begin? The Board recommends
that you use the Board’s Web site to first educate yourself
and your staff on ways to enhance patient safety. To assist
you, the Board is encouraging every pharmacist-in-charge
(PIC) and pharmacy to complete the Pharmacy Survey
on Patient Safety at your practice site. This interactive
self-assessment tool developed by AHRQ will help assess
patient safety awareness in your pharmacy. Initially
developed for clinical pharmacists, the Pharmacy Survey
on Patient Safety can be used to assess patient safety in any
practice setting. A complete survey toolkit and instructions
are available on AHRQ’s Web site at www.ahrq.gov/qual/
patientsafetyculture/pharmsurvindex.htm.
Patient safety is our responsibility. Together, we can help
ensure SAFE PRACTICE, SAFE PATIENTS, and a SAFE
MISSOURI.
Pamela Marshall, RPh
President



Source Missouri Newsletter February 2013

See also Prior Post with Meeting and Agenda

Missouri State Board of Pharmacy Disciplinary Records

are available here along with orders in each case.

Missouri Board of Pharmacy Hospital Working Group Agenda for Feb. 15, 2013 meeting

to view click here

Missouri Board of Pharmacy Patient Safety Working Group Meeting Feb. 7, 2013 and Agenda

Meeting Notice
Missouri Board of Pharmacy
Patient Safety Working Group
February 7, 2013 9:00 a.m. to 3:00 p.m.
Professional Registration
3605 Missouri Blvd
Jefferson City, MO 65109
Notification of special needs as addressed by the Americans with Disabilities Act should be forwarded to the Missouri Board of Pharmacy, P O Box 625, 3605 Missouri Blvd., Jefferson City, Missouri 65102, or by calling (573) 751-0091 to ensure available accommodations. The text telephone for the hearing impaired is (800) 735-2966.
If any member of the public wishes to attend the meeting, s/he should be present at the Division of Professional Registration, Main Conference Room, 3605 Missouri Blvd, Jefferson City, Missouri, at 9:00 a.m. on February 7, 2013.
Please see attached tentative agenda for this meeting.
2/4/2013
12:06 PM
TENTATIVE AGENDA
February 7, 2013 9:00 a.m. to 3:00 p.m.
Missouri Board of Pharmacy
Patient Safety Working Group Meeting
Professional Registration
3605 Missouri Blvd
Jefferson City, MO 65109
Conference Call
OPEN SESSION
1 Call to Order
2 Roll Call
3 Welcome/Introductions
4 Description of MoSafeRx 2013 Initiative
5 Committee Purpose/Goals
 Oregon Board of Pharmacy
 MoSafeRx Newsletter
 “Take the Pledge”
 Statutory/Rule Review
6 Open Discussion: Committee Member Goals/Suggestions
7 Lunch/Open Discussion- con’t. (Lunch will be provided)
8 Defining “Patient Safety”
9 Patient Safety & Clinical Pharmacy Services Collaborative
U.S. Dept. of Health and Human Services,
Health Resources and Services Administration
10 Patient Safety Organizations (PSOs) & Community Pharmacy
11 Future Agenda Suggestions
12 Adjournment

Missouri Board of Pharmacy Annual Report--Compounding Issues Are Some of Issues Addressed

To view the report click here

Missouri Board of Pharmacy Disciplining Those Who Violate Compounding Rules and Regulations

Missouri Board of Pharmacy appears to be aggressive against pharmacies and pharmacists who violate the rules relating to compounding drugs.  Here are a few examples:

Dennis L. Stockstill, #028884 – Richland, MO – August 22, 2011.
Probation for three (3) years. As pharmacist-in-charge, pharmacy
personnel compounded without proper licensure, equipment, or
environment; dispensed compounded substances with expired
ingredients and in batches that exceeded their beyond-use date;
maintained deficient compounding logs; misbranded and adulterated
compounded products; failed to issue a recall of misbranded
drugs; failed to supervise personnel to ensure compliance with
laws/regulations. Section 338.055.2(5), (6), (13), and (15), RSMo


Erin E. Thomas, #2005011039 – St Louis, MO – September 22,
2011. Probation for two (2) years to begin January 1, 2012. Use
of unlicensed facility to prepare sterile compounds; misbranded,
outdated, and inappropriately maintained drugs; compounded
commercially available products; dispensed sterile products without
documented prescriber authorization prior to end-product testing;
failed to validate beyond-use dates; compounded without a prescription.
Section 338.055.2(6) and (13), RSMo


Franck’s Compounding Pharmacy, #2005007704 – Ocala, FL
– September 9, 2011. Probation for three (3) years. Disciplinary
action in another state involving compounding of a solution with
incorrect measure of sodium selenite; operated without a license;
and improper labeling. Section 338.055.2(8), RSMo.

M D Pharmacy, Inc, #002337 – St Louis, MO – September 28, 2011.
Probation for three (3) years. Received drugs from non-wholesale,
unlicensed drug distributors; misbranding by overfilling stock
bottles; compounded prescriptions not logged; failed to maintain
hard copies of controlled substance prescriptions; failed to complete
 CII order forms; filled prescriptions for another pharmacy
without a Class J license; record keeping violations; drug security
violations; technician allowed to work and dispense without a
pharmacist on duty, and counsel patients; and allowed live animal
in pharmacy. Section 338.055.2(5), (6), (10), (13), and (15), RSMo.

Specialty Pharmacy of St Louis, LLC, #2003001140 – St Louis,
MO – September 22, 2011. Probation for three (3) years to begin
January 1, 2012. Compounded other than pursuant to individual
patient prescription; use of unlicensed facility to prepare sterile
compounds; misbranded, outdated, and inappropriately maintained
drugs; compounded commercially available products; dispensed
sterile products without documented prescriber authorization
prior to end-product testing; failed to validate beyond-use dates;
compounded without a prescription. Section 338.055.2(6) and
(13), RSMo

Lee E. Ori, #2000148445 – Des Peres, MO – September 22, 2011.
Probation for three (3) years to begin January 1, 2012. While
pharmacist-in-charge, compounded other than pursuant to an
individual patient prescription; use of unlicensed facility to prepare
sterile compounds; misbranded, outdated, and inappropriately
maintained drugs; compounded commercially available products;
dispensed sterile products without documented prescriber authorization
prior to end-product testing; failed to validate beyond-use
dates; compounded without a prescription. Section 338.055.2(6)
and (13), RSMo.

James A. Cordes, #028128 – Des Peres, MO – December 2, 2011.
Probation for two (2) years. As pharmacist-in-charge, misbranding,
compounded prescriptions not logged, prescriptions filled for
another pharmacy without a Class J permit, failure to keep complete
acquisition/purchase/distribution records, technician allowed to
work unsupervised and allowed to dispense prescriptions without
a pharmacist on duty, and failed to supervise personnel to ensure
compliance with laws/regulations. Section 338.055.2(5), (6), (13),
and (15). RSMo.

William R. Buntin, #027483 – Moberly, MO – June 10, 2012.
Suspended for three (3) months followed by probation for
five (5) years. While pharmacist-in-charge, violation of discipline
involving outdated drugs in pharmacy, incomplete
controlled substance inventory, failure to timely respond
to inspection compliance notice, compounding log and
product label did not contain active/therapeutic ingredients,
expired license displayed, sold pseudoephedrine products
without a current Methamphetamine Epidemic Self-Certification,
failed to maintain updated electronic record of
controlled substance shipments. Section 338.055.2(5), (6),
(13), and (15), RSMo


Buntins Pharmacy, #003884 – Moberly, MO – March 15,
2012. Probation for five (5) years. Violation of discipline
involving outdated drugs in pharmacy, controlled substance
not included in controlled substance inventory, failure to
timely respond to inspection compliance notice, compounding
log and product label did not contain active/therapeutic
ingredients for a compounded product, expired pharmacist
license displayed, sold pseudoephedrine products without
a current Methamphetamine Epidemic Self-Certification,
failed to maintain updated electronic record of controlled
substance shipments. Section 338.055.2(5), (6), (13), and
(15), RSMo

Pharmacy Solutions, Inc, #2002005329 – St Louis,  MO –
February 22, 2012. Probation for one (1) year. Compounding
without a prescription, unable to substantiate representations
regarding compounded products, compounded
commercially available products, compounding for office
stock, release of risk level 3 products prior to end-product
test completion, failure to investigate test results, failure to
validate beyond-use dates beyond 30 days, and compounded
with products restricted by Food and Drug Administration
(FDA). Section 338.055.2(5), (6), (13), (14), and (15),
RSMo