Brief History: Passed House: 3/11/13, 97-0. Committee Activity: Health Care: 3/27/13.

SENATE BILL REPORT

HB 1800

This analysis was prepared by non-partisan legislative staff for the use of legislative members in their deliberations. This analysis is not a part of the legislation nor does it constitute a statement of legislative intent.

As of March 26, 2013

Title: An act relating to compounding of medications.

Brief Description: Concerning the compounding of medications for physician offices or ambulatory surgical centers or facilities to be used by a physician for ophthalmic purposes for nonspecific patients.

Sponsors: Representatives Cody, Morrell and Schmick.

Brief History: Passed House: 3/11/13, 97-0.

Committee Activity: Health Care: 3/27/13.

SENATE COMMITTEE ON HEALTH CARE

Staff: Mich'l Needham (786-7442)

Background: Compounding is a practice in which a pharmacist prepares a prescription by combining two or more ingredients. Compounding is authorized in specific situations and in limited quantities. The compounding of an inordinate amount of drugs, relative to the practice site in anticipation of receiving prescriptions without any historical basis, is considered manufacturing. Manufacturers must obtain a license and meet additional state and federal regulatory requirements.

The Board of Pharmacy allows pharmacists to conduct compounding in limited situations. Pharmacists may compound drugs for individual patients when there is a pharmacist/patient/prescriber relationship and the patient presents a prescription. Pharmacists may also compound drug products that are commercially available for individual patients when it is in anticipation of orders based upon routine, regularly observed prescribing patterns. In addition, pharmacists may compound drugs in very limited quantities prior to receiving a prescription based upon a history of receiving prescriptions from a certain pharmacist/patient/prescriber relationship.

Pharmacists are prohibited from offering compounded drug products to others for resale, except to a practitioner to administer to an individual patient.

Summary of Bill: The Board of Pharmacy must adopt rules to authorize the compounding of ophthalmic medications for use by a physician for nonspecific patients in physician offices, ambulatory surgical centers, and ambulatory surgical facilities. The rules must establish limits on the quantities that may be made available and requirements to record the dispensing of the compounded medication, including the identity of the patients and the amounts dispensed.

The term manufacture, as it relates to legend drugs, excludes the compounding of ophthalmic medications for use by a physician for nonspecific patients in physician offices, ambulatory surgical centers, and ambulatory surgical facilities.

Appropriation: None.

Fiscal Note: Available.

Committee/Commission/Task Force Created: No.

Effective Date: The bill contains an emergency clause and takes effect immediately.

Drug plan targets a need, not greed

Imagine a newborn baby in an intensive care unit who needs a specific, customized drug. Imagine further that there is another baby in the unit who needs the same drug. Now imagine there is only enough of the drug on hand for one of them, and you have to decide who receives it.

This and similar situations are playing out in hospitals, ambulances and specialized clinics throughout the nation — the result of a serious and widespread drug shortage that’s growing more critical every day.

Legislation amending existing state law being considered by the General Assembly would allow Tennessee pharmacists to help alleviate this problem. It does not compromise patient safety and will help compounding pharmacies safely make specialized medicine for vulnerable patients whose lives depend on its availability.

Continue reading here

PCCA Suggested Guidelines for Choosing a Compounding Pharmacy A Has some Excellent Suggestions For Choosing a Compounding Pharmacy

Suggested Guidelines for Choosing a Compounding Pharmacy

When you initially contact a compounding pharmacy, you may want to ask them for the following information:

1. Does the pharmacy use PCCA-tested Formulas and Pharmaceutical Ingredients?
2. What initial training is required for the pharmacy staff members when they begin working there?
3. What ongoing education do staff members receive? Do they participate in formal continuing compounding education programs?
4. Does the pharmacy have a quality assurance and continuous quality improvement program? Does the pharmacy have its compounded preparations tested for potency to ensure you are getting the right amount of medication? Do they test their sterile preparations to ensure sterility? Ask for details.
5. How are patients educated on the appropriate use of their compounded prescriptions? Does the pharmacy conduct a review of all the patients' current medications along with any compounded preparations?
6. If the pharmacy is in a different state than the one you reside in, and you are considering having them ship a compounded prescription to you, first verify that they are appropriately licensed to dispense prescriptions in your state as well.

Question quoted from here

NABP States Take Action to Ensure Safety of Compounded Drugs March 27, 2013 3:00 pm

Through board of pharmacy inspections of compounding pharmacies and proposed laws to tighten requirements for compounding, states are taking action to help ensure the safety of compounded drugs, reports The Washington Post. The article highlights the ongoing Iowa nonresident compounding pharmacy inspection program, a program initiated in partnership with NABP. Any disciplinary actions resulting from inspections would have to be addressed by other boards of pharmacy, Lloyd Jessen, JD, RPh, executive director, drug control program administrator, Iowa Board of Pharmacy, and NABP Executive Committee member told The Washington Post. The report also notes that the United States Food and Drug Administration (FDA) is in support of legislation that would authorize the agency to regulate entities that operate like manufacturers, though they are registered as compounding pharmacies. “Rather than wait for the decision on whether it’s going to be FDA or the states,” boards of pharmacy are going to make sure they do their best to protect patients, noted Carmen Catizone, MS, RPh, DPh, NABP executive director/secretary. 

More information about the Iowa compounding pharmacy inspection program and other issues related to the regulation of compounding are included in the April 2013 NABP Newsletter article “Compounding Pharmacy Information Sharing Network Available to Boards Soon” (PDF).

Quoted from here

2013 Annual Meeting State Boards of Pharmacy and NABP—Gateway to Shared Responsibility and Success May 18-21, 2013 St Louis, MO

For more information click here

Veterinary Pharmacy Issues: Identifying Illegal Practices and Distinguishing Supply Chain Variations ACPE #205-000-13-004-L03-P

Monday, May 20, 2013

8:15 - 10:15 AMJoint CPE

Veterinary Pharmacy Issues: Identifying Illegal Practices and Distinguishing Supply Chain Variations

ACPE #205-000-13-004-L03-P
(0.2 CEUs – 2 contact hours)

Target Audience: Pharmacists
Activity Type: Application-based

Learning ObjectivesAt the conclusion of this session participants will be able to:

1. Illustrate why pharmacists who dispense veterinary medicines should possess particular skills.
2. Describe the additional training necessary for pharmacists to practice veterinary pharmacy.
3. Explain the legal differences between the human and veterinary drug supply chain.

DescriptionMany pet owners think that Fido is part of the family, but who should prescribe and dispense veterinary medicines? This session’s discussion will center around what knowledge is necessary regarding drug therapy and pharmacokinetics in veterinary medicine and why a lack of such knowledge may place our animal counterparts at risk. Additionally, attendees will learn the differences between the two drug supply chains – the how and the why the veterinary drug supply chain is legally allowed to be separate and vary from the human drug supply chain.

For more information click here

The Compounding/Manufacturing Debate: When Is a Duck Not a Duck? ACPE #205-000-13-001-L03-P

Saturday, May 18, 2013

2 - 4 PM

Pre-Meeting CPE

The Compounding/Manufacturing Debate: When Is a Duck Not a Duck?

ACPE #205-000-13-001-L03-P
(0.2 CEUs – 2 contact hours)

Target Audience: Pharmacists
Activity Type: Application-based

Learning ObjectivesAt the conclusion of this session participants will be able to:

1. Explain how a compounding pharmacy might be registered as a manufacturer by Food and Drug Administration (FDA).
2. Describe how states can enforce their regulations when it comes to the activities of compounding pharmacies acting as manufacturers.
3. Describe how compounding pharmacies that are acting as manufacturers may be regulated in the future.

DescriptionThe New England Compounding Center tragedy resulted in regulators conducting in-depth investigations of compounding pharmacies. This has brought to light the realization that these types of entities may be operating in a gray area of law. During this special pre-meeting continuing pharmacy education (CPE) panel session, federal and state regulators and compounding experts will discuss the perplexities surrounding the issue of compounding pharmacies acting as manufacturers and the resultant and ongoing regulatory challenges facing the boards of pharmacy.

For more information click here

AVMA Now: Toolkits, Fly-Ins, and Compounding

AVMA Now: Toolkits, Fly-Ins, and Compounding

Safety Alerts for Human Medical Products Palimed Solutions, Inc. Sterile Compound Products: Recall - Visible Particulates Observed

Safety Alerts for Human Medical Products Palimed Solutions, Inc. Sterile Compound Products: Recall - Visible Particulates Observed

Radford v. New England Compounding Pharmacy, Inc. et al

Radford v. New England Compounding Pharmacy, Inc. et al