Reminder: Florida Pharmacy Association Law and Regulatory Conference - Sandestin--including ethics, compounding, HIPPA and compliance

When:	1/25/2014 07:00
Where:	Map this event » Hilton Sandestin Beach Golf Resort and Spa 4000 Sandestin Beach Blvd Destin, Florida  32550 United States
Contact:	Stacey Brooks sbrooks@pharmview.com more information here

Save the Date for 3-1 compounding conference-practice-based, compounding, and veterinary clinical and compounding.

3-in-1 conference that brings the pharmacy profession together in paradise. The American College of Apothecaries (ACA), the International Academy of Compounding Pharmacists (IACP) and the American College of Veterinary Pharmacists (ACVP) are joining forces again to bring you an extraordinary Educational Conference, February 5-8, 2014 at the ocean front property, the Harbor Beach Marriott Resort & Spa in Fort Lauderdale, Florida.

What you can expect in 2014:

•Benefit from multiple education tracks; practice-based, compounding, and veterinary clinical and compounding.
•Learn the fundamental steps to successfully work with your local media. 

•Develop a Social Media campaign about your pharmacy and its role in the community.  •Leverage the latest tools and resources to implement a quality improvement plan in your pharmacy. •Hear what your peers are doing in the This Works for Me! sessions. •Tips for hiring and retaining good employees for a successful pharmacy.  •What’s New in Veterinary Pharmacy, and much more!•Visit with companies showcasing services that can improve your business. 

More information found here

Community Pharmacists Urge Senate To Split Drug Tracing, Compounding

Community pharmacists are urging Senate lawmakers to split drug tracing and compounding legislation into two bills so that Congress can move forward with the drug supply chain measure and continue to resolve stakeholder concerns with the drug compounding portion of the bill.

Oregon Board of Pharmacy Discussed Appropriate Registration for Compounding Outlets update During October Meeting

To view agenda click here

Ohio Board of Pharmacy Guidance Regarding Compounding in Ohio

COMPOUNDING IN OHIO
We recognize and enforce Federal law that compounding is performed by a pharmacist in a
pharmacy and pursuant to a patient specific prescription.  Refer to 21 USCA 353a
 You may not compound FDA approved drugs that are commercially available.
 On July 9, 2012, President Obama signed into law the FDA Safety and Innovation
Act which in part grants permission for hospitals and health systems to repack and
share drugs, not controlled substances, in short supply during an FDA published
shortage plus 60 days after the drug is taken off the list. Caveat: only within the
same health system    
http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/Significant
AmendmentstotheFDCAct/FDASIA/ucm313121.htm
Our state law defines compounding in ORC 4729.01(C)
(C) “Compounding” means the preparation, mixing, assembling, packaging, and
labeling of one or more drugs in any of the following circumstances:
(1) Pursuant to a prescription issued by a licensed health professional authorized
to prescribe drugs;
(2) Pursuant to the modification of a prescription made in accordance with a
consult agreement;
(3)  As an incident to research, teaching activities, or chemical analysis;
(4) In anticipation of orders for drugs pursuant to prescriptions, based on routine,
regularly observed dispensing patterns;
(5) Pursuant to a request made by a licensed health professional authorized to
prescribe drugs for a drug that is to be used by the professional for the purpose
of direct administration to patients in the course of the professional’s practice,
if all of the following apply:
(a) At the time the request is made, the drug is not commercially available
regardless of the reason that the drug is not available, including the
absence of a manufacturer for the drug or the lack of a readily available
supply of the drug from a manufacturer.
(b) A limited quantity of the drug is compounded and provided to the
professional.Compounding in Ohio
Page 2 of 5 rev 9/12
(c) The drug is compounded and provided to the professional as an
occasional exception to the normal practice of dispensing drugs pursuant
to patient-specific prescriptions.
Note: also refer to OAC 4729-9-25 below for specifics relating to (5)
We further regulate compounding in the following rules:
DRUGS COMPOUNDED IN A PHARMACY      OAC Rule 4729-9-21
Please review particularly:
(F) A prescription shall be compounded and dispensed only pursuant to a
specific order for an individual patient issued by a prescriber. A
limited quantity may be compounded in anticipation of prescription drug
orders based on routine, regularly observed prescribing patterns.
(G) A compounded prescription that is dispensed to a patient must be
labeled according to rule 4729-5-16 of the Administrative Code.
DRUGS COMPOUNDED FOR DIRECT ADMINISTRATION BY A PRESCRIBER
OAC Rule 4729-9-25
Please review particularly:
A pharmacist may compound a drug pursuant to a request made by a
prescriber, or by an agent of the prescriber, for a drug to be used by the
prescriber for the purpose of the direct administration to patients in the
course of the prescriber's practice pursuant to division (C)(5) of section
4729.01of the Revised Code and the following:
(A) The drug is compounded and provided to a prescriber as an occasional
exception to the normal practice of dispensing drugs pursuant to patient
specific prescriptions:
(1)  A pharmacy may provide compounded drug preparations to
prescribers for direct administration to patients as long as the total
value of those compounded preparations does not exceed five percent
of the pharmacy's total dollar amount of sales of patient specific
compounded prescriptions within the past twelve months.
(2) The pharmacy shall only provide those compounded drugs that are
not commercially available to a prescriber which are needed:
(a) To treat an emergency situation;
(b) For an unanticipated procedure for which a time delay would
negatively affect a patient outcome;
(c) For diagnostic purposes.
(B) A pharmacy shall not supply more than a seventy-two hour supply of a
compounded drug to a prescriber. A prescriber shall not have more than
a seventy-two hour supply of a compounded drug on hand at any given
time. The seventy-two hour supply provided to the prescriber shall be
determined by previous administration patterns provided by a Compounding in Ohio
Page 3 of 5 rev 9/12
prescriber to the pharmacist. The limitation of a seventy-two hour
supply shall not apply to either of the following:
(1) Compounded non-sterile drug preparations for topical administration,
pursuant to paragraphs (A)(2)(b) and (A)(2)(c) of this rule, shall be
supplied to a prescriber in a single container in which the quantity
does not exceed sixty grams or sixty milliliters. A prescriber shall not
have more than one full container of sixty grams or sixty milliliters of
a compounded drug on hand at any given time; or
(2) Compounded non-sterile drug preparations intended to treat an
emergency situation, pursuant to paragraph (A)(2)(a) of this rule, may
be provided to a prescriber in a quantity required to sufficiently treat
individuals in the event of an emergency situation.
(C) A pharmacy shall not sell a compounded drug to another pharmacy
or wholesaler.
(D) Prescribers shall only administer a requested compounded drug directly
to their own patients. Prescribers shall not:
(1) Dispense a compounded drug to a patient;
(2) Sell a compounded drug to another prescriber;
(3) Sell a compounded drug to a pharmacy; or
(4) Return a compounded drug to the supplying pharmacy.
(E)  Compounded drug preparations shall be assigned beyond use dates
that are based on stability and sterility for sterile compounded drug
preparations and stability for non-sterile compounded drug preparations
pursuant to the following:
(1) Beyond use dates for non-sterile compounded preparations shall be
determined by the compounding pharmacy through drug product
testing pursuant to acceptable practice standards; by published peer
reviewed pharmaceutical literature that have been critically reviewed
by unbiased independent experts; or in compliance with requirements
in the current edition of an official compendium, such as the "United
States Pharmacopoeia/National Formulary".
(2) Beyond use dates for sterile compounded preparations shall be
determined by the compounding pharmacy through drug product
testing pursuant to acceptable practice standards or shall be based on
the following "United States Pharmacopoeia/National Formulary"
standards:
(a) Low risk level compounded drug preparations shall be assigned a
beyond use date of not more than forty-eight hours when stored
at controlled room temperature at twenty to twenty-five degrees
celsius, or fourteen days when refrigerated at two to eight
degrees celsius, or forty-five days in solid frozen state at minus
twenty-five to minus ten degrees celsius.
(b) Medium risk level compounded drug preparations shall be
assigned a beyond use date of not more than thirty hours when
stored at controlled room temperature at twenty to twenty-five
degrees celsius, or nine days when refrigerated at two to eight Compounding in Ohio
Page 4 of 5 rev 9/12
degrees celsius, or forty-five days in solid frozen state at minus
twenty-five to minus ten degrees celsius.
(c) High risk level compounded drug preparations shall be assigned
a beyond use date of not more than twenty-four hours when
stored at controlled room temperature at, twenty to twenty-five
degrees celsius, or three days when refrigerated at two to eight
degrees celsius, or forty-five days in solid frozen state at minus
twenty-five to minus ten degrees celsius.
(F) The labeling of a compounded drug preparation must contain the
following:
(1)  The statement "For direct patient administration only" displayed
prominently;
(2)  The statement "Not for resale" displayed prominently;
(3)  Proper storage conditions;
(4)  Beyond use dates pursuant to paragraph (E) of this rule;
(5)  The name(s) of the active and inactive ingredients;
(6)  The amount or percentage of active drug ingredients;
(7)  The quantity of compounded drug provided;
(8)  The route of administration;
(9)  The pharmacy name, address, and telephone number;
(10) The pharmacy control number assigned to the compounded drug
preparation.
(G) Compounded drug preparation containers that are too small to bear a
complete label pursuant to paragraph (F) of this rule must bear a label
that contains at least the following information:
(1) "Not for resale";
(2) The storage conditions if other than room temperature;
(3) The beyond use date;
(4) The drug name(s);
(5) The drug strength;
(6) The route of administration;
(7) The pharmacy control number;
(8) The pharmacy name.
In all cases, a complete label meeting the requirements of paragraph (F)
of this rule must be applied to the outside container in which such
compounded preparation is supplied.
(H) The sale of a compounded drug preparation to a prescriber is
considered a wholesale sale as defined in section 4729.01 of the
Revised Code. A pharmacy is required to follow the record keeping
requirements for wholesale sales listed in paragraph (H) of rule 4729-9-
16 of the Administrative Code.
(I) A pharmacy must follow the compounding requirements pursuant to
rules 4729-5-25 and 4729-9-21 of the Administrative Code, Chapter
4729-19 of the Administrative Code, current professional
compounding standards, and all applicable federal and state laws,
rules, and regulations.Compounding in Ohio
Page 5 of 5 rev 9/12
In addition, all prescriptions must be sent to the PATIENT
If you want to ship ANY patient specific medications to the prescriber rather than the patient,
you must have Board approval (specific to each prescriber office/pharmacy) prior to any such
shipment pursuant to
PRESCRIPTION PICK-UP STATION    OAC Rule 4729-5-10
Please review particularly:
(B)  No pharmacist shall dispense dangerous drugs to a place which offers, in
any manner, its services as a "pick-up station" or intermediary for the
purpose of having prescriptions filled or delivered unless such place is a
pharmacy as defined in section 4729.01 of the Revised Code, has
received board approval to function in such a manner, and paragraphs
(B)(1) to (B)(4) of this rule apply or, if not a pharmacy, unless all of the
following apply:
(1)  The site is appropriately licensed pursuant to Chapter 4729. of the
Revised Code.
(2)  The receipt, storage, control, and distribution of prescriptions or
drugs are in the full and actual charge of a health care professional
licensed pursuant to Chapter 4715., 4723., 4729., 4730., 4731., or
4741. of the Revised Code.
(3) An appropriate recordkeeping system is in place that will provide
accountability for proper receipt, delivery, and return of all
prescription medications.
(4) There is a documented method in place to ensure compliance with
rule 4729-5-22 of the Administrative Code.
(5) The state board of pharmacy has approved the site for such activity
due to clear and convincing evidence that delivery of prescription
medication directly to the patient would result in:
(a) Danger to public health or safety, or
(b) Danger to the patient without increased involvement by a health
care professional in the patient’s drug therapy.
If your special circumstance meets these criteria, you must request approval to ship to a
pick-up station rather than to the patient using the request form that is available on our
website

Ohio Board of Pharmacy Discusses Basic Differences Between Manufacturing and Compounding Under Its Rules

Manufacturing Versus Compounding: 

Basic Differences

Manufacturing and compounding are two very different 

practices that are regulated differently as well. Ohio recognizes and 

enforces federal law that states compounding 

is performed by a pharmacist in a pharmacy and pursuant to a 

patient-specific prescription (refer to 21 USCA 

353a). Manufacturing does not require a patient-specific 

prescription, but requires a manufacturing license from

FDA that enables the company to produce and sell manufactured medications 

(typically in bulk) again without a 

patient-specific prescription. To obtain an FDA manufacturing license, 

the manufacturing site must also pass 

stringent quality assurance standards (good manufacturing practice) 

designed to test manufacturing of sterile 

drug product. Thus, there is much more scrutiny placed 

on this type of practice (manufacturing) typically due to 

the large amounts of drug product being made for resale. 

Medication compounding, on the other hand, involves 

the practice of taking commercially available products 

and modifying them to meet the unique needs of an individual

 patient pursuant to a prescription from a licensed 

provider. Our state law defines compounding in Ohio 

Revised Code 4729.01(C). Also, a pharmacy must follow 

the compounding requirements pursuant to Ohio Administrative Code 

(OAC) Rules 4729-5-25, 4729-9-25, 4729-

9-21, and 4729-19; current professional compounding 

standards; and all applicable federal and state laws, rules, 

and regulations. As required by OAC 4729-19-04, for 

compounding sterile injectables, the Board would expect 

to see in your written policies and procedures adherence 

to United States Pharmacopeia (USP) Chapter 797 guidelines. 

These guidelines are differentiated by the severity/

risk of the type of products being compounded. The Board 

expects that you review and understand these guidelines 

to assess your practice prior to compounding sterile injectable

 prescriptions. For more information regarding 

the USP Chapter 797 compounding guidelines, visit www

.usp.org/store/products-services/usp-compounding. 

Compounding in Ohio does not require a special FDA 

manufacturing license and can be performed with no 

extra licenses other than those required by the Board 

for pharmacy practice (RPh license for the pharmacist 

to practice, a terminal distributor of dangerous drugs 

license for the location, and, if needed, a Drug Enforcement 

Administration license for controlled substances). 

No doubt, compounding is a legal and common practice 

in many Ohio pharmacies and brings incredible value to 

Ohio patients. However, make sure that your processes 

meet all standards for compounding and that you are not 

manufacturing as defined above. The Board has created 

a great compounding document for review, which can be 

accessed from the Board’s Web site at www.pharmacy

.ohio.gov. Click on the “Terminal Distributor (TDDD) Licenses”

 tab and then on the “Compounding in Ohio” link. 

Source found here

Arizona Veterinary Board Compounding Answers

The Arizona Veterinary Medical  Examining Board Scratching Post Newsletter dated February 2012 contained the following questions and answers regarding compounding:

This was submitted by an attorney that presented this Information to the Board at their December 21, 2011

meeting. The Board has not adopted policies to address or enforce these interpretations.

Q: Why are some pharmacies willing to sell bulk compounds for veterinary hospital dispensing and others are

not?

A:  The pharmacists may not be aware that the clinic is dispensing the medications for clients to take home, or the pharmacy may be unfamiliar with the laws governing this practice.

Q: What If I am not reselling the compounded medication, rather I am providing the take-home portion of a compounded medication that was  obtained from a pharmacy free of charge?

A: Both reselling and dispensing at no-fee are restricted to the practice of pharmacy in Arizona.

Q: Does this mean that veterinarians must write a prescription for 100% of the compounded medications

used to treat animals outside of the clinic?

A:  Yes

Q: Does this mean that veterinarians are restricted from sending a small quantity of compounded medications home with the patient to cover the period of time between the patient’s visit and the

pharmacy’s filling of the prescription?

A: Yes

Q: What if my practice works exclusively with rescued animals that are under foster care, can a pharmacy

provide my practice with pro-made compounded medications to send to the foster homes?

A: No. Even fostered animals cared for outside of the clinic or hospital require the veterinarian to arrange for a pharmacy to fill the prescription.

Q: What If there is an acute  need for a compounded medication and the animal cannot wait?

A: Most specialty pharmacies that provide compounding services understand these challenges and provide emergency services. The specialty pharmacies can also arrange for delivery of medications to rural areas, usually within 24 hours. Collaborating with a trained veterinary pharmacy specialist can often provide

the veterinarian with several options during emergency situations to accommodate acute needs.

Q: Can the State of Arizona update the veterinary practice act to address this issue?

A: The legislature does a have process and the power to expand the veterinary practice to show veterinarians more options as they pertain to compounding services.

 

COMPOUNDED MEDICATIONS

FREQUENTLY ASKED QUESTIONS

Submitted by Roger Morris

Source is found here