The Law of Compounding Medications And Drugs

Wednesday, July 3, 2013

Oregon Board of Pharmacy Rule Changes

July 1, 2013

On June 12, 2013 the Board amended the following fees: Reciprocity, County Health Clinics, Family Planning Clinics, Hospital Drug Rooms, Correctional Facilities, Prophylactic/Contraceptive Outlets, Retail and Institutional Drug Outlets, Home Dialysis Drug Outlets and all Controlled Substance registration fees.

The Board implemented a temporary fee reduction for these fees as allowed by ORS 291.055(3) due to an unexpected surplus in revenue. These fee reductions are in addition to the temporary pharmacist licensure fee reduction that went into effect on April 5, 2013.
Certificate and Order for Filing Temporary Administrative Rules - Effective July 1, 2013

855-110 - Fees

June 27, 2013 Rulemaking Hearing

On Thursday, June 27, 2013 at 9:30AM, the Oregon Board of Pharmacy will conduct a rulemaking hearing on the following topics in Room 1A of the Portland State Office Building, 800 NE Oregon St., Portland, OR 97232.

Notice of Rulemaking Hearing and Statement of Need

Div 019 - Consulting Pharmacist Practice
Div 041 - Preamble for Central Fill, Remote Processing and Consulting or Drugless Pharmacies
Div 041 - Central Fill
Div 041 - Remote Processing
Div 041 - Consulting or Drugless Pharmacies
Div 041 - Customized Patient Medication Packages
Div 060 - Manufacturers
Div 080 - Controlled Substances

Remote Processing Drug Outlet rules provide minimum requirements of operation for centralized prescription processing by a pharmacy that processes drug orders on behalf of an Oregon pharmacy.

Central Fill Drug Outlet rules provide minimum requirements of operation for centralized prescription drug filling by a pharmacy that fills drug orders on behalf of an Oregon pharmacy.

Consulting or Drugless Pharmacy rules are intended to ensure that a consulting pharmacist may safely store records and protected health information in an Oregon licensed drugless pharmacy when engaged in Independent Pharmacy Practice.

Consulting Pharmacist Practice rules are amended to establish registration requirements for a consulting pharmacist that stores health protected records outside an Oregon licensed pharmacy.

Customized Patient Medication Packages rules are amended to include a waiver clause.

Manufacturer rules are amended to clarify that any compounded non-patient specific drug from an

out-of-state drug outlet may only be distributed into the state by an Oregon registered manufacturer.

Controlled Substance rules are amended to include certain synthetic cannabinoids and cathinone-type derivatives that are subject to abuse, and have no legitimate medical purpose.

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Ohio Board of Pharmacy May 6-8 2013 Minutes--including disciplinary actions

can be read here

PCCA Compounding Courses

Class Schedule

Read course descriptions here.

Introductory Compounding Lab Boot Camp

Status: Sold out
Location: Houston, Texas
Date: August 12-13, 2013

Status: Click to register
Location: Houston, Texas
Date: December 12-13, 2013

Advanced Compounding Training Program - Fall 2013 (10-Week Online Component and Lab)

Status: Click to register
Location: Houston, TX
Date: September 9, 2013

Veterinary Compounding Training Program - Fall 2013 (10-Week Online Component and Lab)

Status: Click to register
Location: Houston, TX
Date: September 9, 2013

Veterinary Compounding Training Program - Fall 2013 (10-Week Online Component ONLY)

Status: Click to register
Location: Houston, TX
Date: September 9, 2013

Tuesday, July 2, 2013

Troubled pharmacy stops trading due to contaminated product

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By Tim Sandle

Jul 2, 2013 - 6 hours ago inHealth

California Pharmacy Association Compounders Day 2013 CE

Compounders Day 2013
Saturday September 28th, 2013

Compounders Day is a unique venue that offers pharmacists and pharmacy technicians practicing in a compounding environment to meet and network with their colleagues and compounding vendors. Earn up to 6 hours of CE from educational programs that are selected by compounding pharmacists and tailored to your specific interests.
Join us for a day and earn 6 CE hours:

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Quality Control and Personnel Validation

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Regulatory Update: Late Breaking Federal and State Update
- Panelists:
- David Miller, IACP Executive Vice President and CEO
- Elizabeth Scott Russell, NABP Government Affairs Manager
- Tony Park, California Pharmacy Law

Registration Fees
Online Registration (available until 09-20-2013)
More information found here

CPhA Pharmacist Member: $229
CPhA Non-Member $495 (Includes CPhA Membership!)
Technician CPhA Member: $99
Technician CPhA Non-Member: $199
Student: $59

On-site Registration

CPhA Pharmacist Member: $329
CPhA Non-Member $595 (Includes CPhA Membership!)
Technician CPhA Member: $99
Technician CPhA Non-Member: $199
Student: $59

Click Here to Register Now!

Managing Drug Recalls in the Compounding Environment Stephen Speth, RPh, MS

July 2012 Of the 42 Class I recalls issued in 2011, only 14 required notification to the consumer or patient level; seven of these recalls were for injectable products that could have been used to prepare compounded sterile preparations (CSPs), yet in none of these cases did the recall notification direct the hospital to contact patients who may have received the recalled product.¹ However, in certain situSations, patient contact is required² and if the pharmacy has no method by which to identify specific product lot numbers used in the preparation of CSPs, attempts at such contact will not only be unwieldy, they will also affect many more patients than would realistically be necessary. Imagine the following scenario, which may seem all too familiar.

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07-02-2013 | 15:10 PM Author: John Stahl The Blessing and the Curses of Compounded Drugs: Insurer Pulls Coverage Following Meningitis Outbreak

By John Stahl, Esq.

The FDA website defines “pharmacy compounding” as “a practice in which a licensed pharmacist combines, mixes, or alters ingredients in response to a prescription to create a medication tailored to the medical needs of an individual patient.” A simpler way of understanding this procedure is that a medical care provider determines that someone would benefit more from a customized medication than an “off-the-rack” drug, and the compounding pharmacy fills the prescription for that “made-to-fit” product.

The portion of the FDA’s description that states that “pharmacy compounding, if done properly, can serve an important public health need if a patient cannot be treated with an FDA-approved medication” illustrates the blessing and the curses regarding these hybrid medications.

The blessing is that a compounded drug is “tailored to the medical needs of an individual patient.” This has particular importance to workers’ compensation because the myriad of factors, such as long-term exposure to toxic substances and a simultaneous combination of physical injuries, often hinders determining the optimal “drug cocktail” for a claimant.

The curses include that compounded drugs have not undergone the FDA approval process and that they are not always “done properly.” Additionally, the pharmacies where the compounding occurs overall are subject to less stringent regulation than the manufacturing of the individual compounded drugs, which require the aforementioned FDA approval, that pharmacists combine to make the custom concoctions.

Another portion of the FDA website concisely summarizes more general concerns regarding compounded drugs. Serious risks associated with that practice include:

· Improperly compounded drugs lacking appropriate potency;· Patients using a properly prepared but ineffective compounded drug rather than an effective FDA-approved medication;· Pharmacists who are not properly trained to compound drugs combining drugs that should not be compounded; and· Compound pharmacies that lack appropriate levels of quality control.

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Dr. Kathy senate bill 959 part 1 podcast

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Product Safety Information FACTREL - Veterinarians

Stiff Penalties Tied to Purple Pain, TB-500 By Blood-Horse Staff Updated: Tuesday, July 2, 2013 11:50 AM Posted: Tuesday, July 2, 2013 11:24 AM

The Racing Medication and Testing Consortium has noted that two substances available only through compounding pharmacies are unclassified medications that will be regarded as high-level violations if used in racing.

The RMTC Tactical Research Committee has reviewed data from laboratory analysis of the two substances of concern in racing that have been marketed as powerfully effective drugs: "Purple Pain" and "TB-500."

Both of these substances are non-FDA-approved and only available through compounding pharmacies. Accordingly, under the RCI guideline regarding unclassified medications and foreign substances, the RMTC recommends that any administration of these substances be treated as a prohibited act and that a finding for either substance or their metabolites be treated as a finding for a prohibited substance.

As such, these substances should be treated as an Association of Racing Commissioners Class 1 substance (highest level violation) with Class A penalty guidelines (most severe) attached.

The results of these studies and additional information on those drugs was provided in recent bulletins issued by the RMTC to horse racing drug-testing laboratories, the Organization of Racing Investigators (ORI), and the Association of Racing Commissioners International (RCI).

Purple Pain is marketed as a pain reliever. TB-500 is claimed by some marketing materials to build muscle, speed muscle recovery, stop bleeding, increase red blood cells, and decrease inflammation.

"This effort is part of the RMTC's renewed focus on identifying and detecting illicit substances and eliminating them from racing," stated RMTC scientific advisory committee co-chair Dr. Rick Arthur. "This type of work is intended to ensure the integrity of racing as well as the safety of the equine and human athletes."

The University of California-Davis Kenneth L. Maddy Laboratory, an RMTC accredited laboratory, performed analysis on samples of both of these compounds. Those results were shared with the RMTC.

"We are grateful to the UC-Davis Kenneth L. Maddy Laboratory and the California Horse Racing Board for sharing this information with the RMTC," said RMTC chairman Dr. Robert Lewis. "The pooling of efforts allows the RMTC and all racing stakeholders to make limited funding dollars stretch further."

GOP senator urges vote on drug compounding bill By Elise Viebeck - 07/02/13 01:04 PM ET

The Senate Health (HELP) Committee's top Republican urged leadership to schedule a vote on his bill empowering federal regulators to oversee certain compounding pharmacies.

In a statement Tuesday, Sen. Lamar Alexander (R-Tenn.) said the legislation would prevent future tragedies caused by drug compounders, such as an outbreak of fungal meningitis that has killed more than 60 people since last fall.

"Americans continue to lose loved ones from the meningitis outbreak, and the Commissioner of the Food and Drug Administration has warned us that this will happen again if Congress fails to act," Alexander said.

Read more: http://thehill.com/blogs/healthwatch/medical-devices-and-prescription-drug-policy-/308925-gop-senator-urges-vote-on-drug-compounding-bill#ixzz2Xulx6TNc
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Alexander: Senate Must Vote On Compounding Legislation “As Soon As Possible” Tuesday, July 02, 2013

The lead Republican on the U.S. Senate health committee today called for the full Senate to vote “as soon as possible” on legislation unanimously approved by the health committee in May to clarify oversight of drug compounders, as Centers for Disease Control and Prevention reports the number of deaths caused by a multistate outbreak of fungal meningitis has risen to 61.

Contaminated drugs traced last year to a Massachusetts compounding pharmacy led to the outbreak that has led to 749 illnesses and 61 deaths, the CDC reported Monday.

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Maryland Law Changes Regarding Compounding Pharmacies

Compounding pharmacies will now be subject to state review. These pharmacies change medicine to fit the needs of a particular patient. An example of this is a dose not usually made for infants. Or avoiding a particular part of the medicine if someone is allergic, for example, flu immunizations are grown in eggs and therefore people who are allergic cannot receive them but a compounding pharmacy could create it differently, without the egg.

These pharmacies have not been regulated in the same way as traditional pharmacies are but that is changing after a meningitis outbreak was traced back to a contaminated steroid created in a compounding pharmacy.

Pharmacy Practice News - Hi-Tech Tools Boost Savings, Safety

Medication shortages noted as a 'public health crisis' More than 300 medicines crucial to treating cancer, infections, cardiac arrest, premature infants, pain, and more are in short supplyShady vendors buy injectable drugs, often from "compounding" pharmacies, then resell the drugs at big markups. July 1, 2013

The Philadelphia Inquirer

PHILADELPHIA, Pa. — Rationing medical care is denounced as immoral in the United States, yet it goes on daily in hospitals, clinics, nursing homes, ambulances, and pharmacies.

Since 2006, this country has had worsening shortages of sterile generic injectables — drugs given by shots or intravenously. Currently, more than 300 medicines crucial to treating cancer, infections, cardiac arrest, premature infants, pain, and more are in short supply.

The reasons for this predicament are complex, and the fixes, elusive. The scope, however, is clear from surveys of medical and trade groups. The latest, a University of Pennsylvania poll of oncologists released this month, found 83 percent had dealt with shortages by delayingcancer treatments, omitting doses, using second-choice drugs, or sending patients elsewhere.

"Oncologists are facing wrenching decisions about how to allocate lifesaving drugs," said cancer specialist Keerthi Gogineni, who led the Penn survey.

Why aren't patients and families up in arms?

They may not realize their care was compromised or complicated by a shortage unless their caregivers are unusually candid.

"Patients in an intensive care unit often don't know they've been impacted," said pharmacist Erin Fox, who tracks shortages as manager of the University of Utah's drug-information service. "And the hospitals don't want folks to talk about it. They don't want to admit, 'We had a patient who died because we didn't have this drug.' "

The secret human toll is rising. In the last three years, dozens of deaths due to contaminated drugs have been linked to producers and vendors who have capitalized on shortages. The Institute for Safe Medication Practices (ISMP) in Horsham received hundreds of reports of medication errors, near-disasters, and 15 deaths related to shortages when it surveyed 1,800 health-care practitioners in 2010.

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A Few Things the Senate Needs to Consider With Regard to Pharmaceutical Compounding Quality and Accountability Act- Before It Comes Before the Senate for A Vote

July 2, 2013

by Sue Tuck Richmond

There are a few a things the United States Senate needs to consider as it debates the Pharmaceutical Compounding Quality and Accountability Act. First, pharmacy is pharmacy in the states. Veterinary pharmacy is not separate for the most part. While a few states such as Virginia and Texas have specific veterinary regulations addressing compounding that apply to veterinarians, these regulations do not apply to pharmacies or pharmacists. The state board of pharmacy rules and regulations apply to compounding. I have posed the questioned of whether pharmacy should be pharmacy and whether veterinary pharmacy should be separated out, but right now it is is not in the states. In light of this treatment in the states, it makes little sense for federal legislation to apply only to human compounding. Nor is it clear that the current draft as written would only apply to human compounding.

Second, I have also discussed this issue: the do not compound list. The legislation should require that a committee or a commission. The committee or commission should be made up of not only FDA officials but also knowledgeable compounding pharmacists, pharmaceutical representatives, doctors, veterinarians, marketing representatives, and consumers who meet, discuss and recommend a do not compound list to Congress who must approve it much like it does the United States Sentencing Guidelines factors. This will prevent the FDA from having complete authority over what cannot be compounded.

TN State Pharmacy Board Strengthens Oversight of Drug Compounding

By: CINDY SANDERS

Posted: Monday, July 1, 2013 11:01 am

In the wake of another suspect drug case with reports of adverse patient events, the Tennessee Board of Pharmacy has announced actions to better assure the safe, sterile compounding of drugs by state-licensed entities.The latest incident found officials with the Tennessee Department of Health (TDH) and other state and federal agencies working through the Memorial Day weekend to investigate problems with methylprednisolone acetate (MPA) products produced by Main Street Family Pharmacy, LLC, in Newbern, Tenn.
Reports of adverse events first surfaced in Illinois and North Carolina from patients who received injections of preservative-free MPA (80 mg/mL) after Dec. 6, 2012. By May 24, seven reports of illness had been logged with no report of meningitis or other life-threatening infection. The suspect MPA was shipped to physicians and clinics in 14 states. In Tennessee, seven facilities received the questionable drug — Quality Care, Jackson; PinnaclePain Management Clinic, Union City; Getwell Family Clinic, Jackson; Walker Pain Management Center, Jackson; First Choice Clinic, Dyersburg; Christian Care Clinic, Newbern: and Axis Medical Clinic, White House.
The Tennessee Board of Pharmacy first licensed Main Street Family Pharmacy in 1985, with a license as a manufacturer/wholesaler/distributor being added in 2010. State officials reported the staff of Main Street Family Pharmacy had fully cooperated with the investigation and launched a voluntary recall of all its sterile products even though no known adverse effects have occurred from any other product. The pharmacy is currently on probation as a result of this investigation.
The new measures adopted by the Tennessee Board of Pharmacy collectively address the need for safe, effective medicines while preserving access for patients. “The board is working cooperatively to identify solutions to improve safeguards for public health while not placing unnecessary barriers on sterile compounding pharmacies that would hamper production of much-needed drugs already in short supply,” said Charles E. “Buddy” Stephens, DPh, president of the Board of Pharmacy. “We believe our actions enhance existing safeguards and offer new steps to ensure safe and effective medications are there when needed.”
The board has taken action to:

Expedite suspension of sterile compounding by a pharmacy or manufacturer when a serious problem is discovered. With cause, a sterile compounder’s license can be suspended jointly by an officer of the Board of Pharmacy, its authorized executive director, and the commissioner of the Tennessee Department of Health without having to wait for a full Board of Pharmacy meeting.
Enhance oversight and regulation of drug manufacturing operations in the state. The license for manufacturers will be a separate category. Prior to this move, manufacturers were included in a combined classification with wholesalers and distributors.
Work more closely with the U.S. Food and Drug Administration. The new requirements call for drug manufacturers in Tennessee to show proof their operations are registered with the FDA.
Add a sterile compounding registration to the regular pharmacy license, to the manufacturer license, and to the wholesaler/distributor license.

These initial actions are not expected to be the last. A workgroup from the Board of Pharmacy is collaborating with staff at the TDH to identify additional measures and improvements to address the manufacturing and distribution process. Items under consideration include more proactive inspection with additional emphasis on critical reviews of maintenance and quality control records, interim self-assessment and applicable reporting by the licensed entities, and adoption of applicable U.S. Pharmacopeia Standards. Additionally, three more licensed pharmacists are being recruited by the Board of Pharmacy to serve as inspectors and another administrative staff person will be added to facilitate the new self-assessment and reporting responsibilities.
“It’s a great challenge to strike a thoughtful, protective balance between addressing the daily drug shortages faced by patients and healthcare providers across Tennessee with the absolute need to assure safety and effectiveness in the compounded product,” said TDH Commissioner John Dreyzehner, MD, MPH. “While we wish the current situation associated with a Tennessee pharmacy had not happened and that patients had not been affected, the actions taken by the board, along with legislation passed recently, are moving us forward in assuring the safety and availability of important medications.”
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Monday, July 1, 2013

Veterinarian Survey This information is taken from a May 2013 survey of the customers of one of the largest veterinary compounding pharmacies in the U.S.

for the information click here

Moving Closer to Achieving Our Vision July 1, 2013

IN THE LAST 20 YEARS, the ASHP House of Delegates has debated and passed important proposals like support for the entry-level Pharm.D., universal health insurance, mandatory reporting of medication errors and “just culture,” collaborative practice, and the implementation of health information technology. In recent years, the ASHP House of Delegates has approved policies that set future goals for residency training for all practitioners in direct patient care roles; defined the role of pharmacist prescribing in interprofessional patient care; called on federal officials to take action on compounding, drug shortages, REMS, and meaningful use standards; and pushed for standardized education, certification, registration, and licensure requirements for pharmacy technicians. These policies touch every facet of pharmacy practice and have a profound impact on medication use in this country. ASHP’s professional policies offer a vision for the future of the profession in which pharmacists are essential members of every health care team and where medication use is optimal, safe and effective for all people, all of the time. Last month, the ASHP House of Delegates approved more than 20 new professional policies during its session at the 2013 Summer Meeting in Minneapolis. Along with passing measures that support training in team-based patient care for student pharmacists and residents and the reclassification of hydrocodone combination products under the Controlled Substances Act, delegates also took strong positions on compounding safely and achieving provider status for pharmacists. These actions are emblematic of the leadership that ASHP has taken on key medication-use issues throughout its history. ASHP’s professional policies provide a solid foundation for the Society to pursue transformative solutions to the issues that affect our ability to care for our patients. In particular, the newly approved policies on compounding by health care professionals and pharmacist recognition as health care providers highlight this principle. Compounding ASHP is actively engaged in federal efforts to close gaps in the regulatory oversight of pharmaceutical compounding activities. We’ve worked closely with members of Congress and congressional staff on legislation that we expect the Senate to vote on this month; namely, the Pharmaceutical Quality, Security, and Accountability Act. While this legislation addresses federal authority, our new policy focuses on the laws and regulations that govern traditional compounding that occurs in hospitals, clinics, and other areas within health systems. It advocates for the adoption of applicable standards of the United States Pharmacopeia by state legislatures and boards of pharmacy. The laws and regulations governing compounding vary from state to state. It is essential for the safety of all patients that all pharmacies that compound medications, regardless of the setting, adhere to the very highest standards. A uniform standard will help to ensure that the medications our patients receive are safe and that they are not harmed by agents that are intended to help them. Pharmacist Recognition as a Health Care Provider -

See more at: http://www.ashpintersections.org/2013/07/moving-closer-to-achieving-our-vision/#sthash.hlcampvp.dpuf

Virginia’s Griffith works on draft proposal for compounding legislation July 01, 2013 Association comments on compounding discussion draft

In June 21 comments on Rep. Morgan Griffith’s (R-VA) compounding discussion draft, APhA recommended modifications in the draft pertaining to radiopharmaceuticals, an advisory committee on compounding, more clarity on state oversight, and more resources forinspections.

Griffith has taken the lead on drafting compounding legislation for the House Energy & Commerce Subcommittee on Health. He requested an updated comment letter from the Association. APhA is working with Griffith’s office as the legislative process moves forward.

“There needs to be clear delineation with respect to state and FDA authorities and requirements regarding compounding and inspection authorities,” APhA wrote in the letter on the topic of state oversight. “While we agree FDA should have inspection authority if a pharmacycrosses the line into manufacturing, this line should be drawn in advance to avoid surprises.”

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House Republicans may introduce compounding legislation soon

July 1, 2013. At the request of Rep. Morgan Griffith (R-VA), who has taken the lead on drafting compounding legislation for the House Energy & Commerce Subcommittee on Health, APhA commented June 7 on a regulatory concept that relied on a draft Compliance Policy Guide that had been under development by FDA before the recent fungal meningitis outbreak.

“While APhA is supportive of making sure that nothing like this occurs again, we are also concerned that overreaching changes to the law could inadvertently block patient access to needed compounded medications,” the Association wrote in the comment letter. “Our utmost concerns are patient safety and access to best treatment options and access to quality medications, including appropriate compounded medications.”

APhA staff meet with Griffith’s office

Following the requested comment letter, APhA staff met with Griffith’s office on June 10 and will continue to work with him as the legislative process moves forward. “It was a very productive meeting,” said APhA Senior Lobbyist Michael Spira. “I would expect we might see legislation in the coming weeks.”

House Republicans are pushing to introduce compounding legislation in the near future because on the Democrat-controlled Senate side, the Health, Education, Labor, & Pensions Committee chair and ranking member have asked Senate Majority Leader Harry Reid (D-NV) to put its compounding bill on the floor by the July 4 recess, according to Spira. The House “has to put its marker down or they will be forced to deal with the Senate bill,” he explained. Even though the Senate bill is bipartisan, the House has indicated it won’t take up the Senate bill.

The House Energy & Commerce Subcommittee on Health held a hearing on examining drug compounding on May 23. Two previous hearings on compounding were held by the Subcommittee on Oversight and Investigations.

‘Compounding is part of the pharmacy profession’

The Association’s June 7 letter to Griffith’s office highlighted several compounding issues and referred to 2008 APhA policy on pharmacy compounding accreditation (see sidebar).

“Compounding is an integral part of the pharmacy profession and was virtually synonymous with the practice of pharmacy for many years prior to the inception of large-scale and widespread pharmaceutical manufacturing,” APhA wrote. “Common examples where compounding serves a critical patient need include preparing dosage forms to enhance medication administration and adherence, preparing a formulation that excludes an ingredient known to trigger a patient’s specific allergic response, maintaining a patient on a medication when there is a drug product shortage, and providing a drug product in a specific and customized strength or dosage form. In addition, cancer patients with challenged oral intake may require oral medications compounded into other dosage forms that meet that particular patient’s needs.”

Continued APhA’s letter: “There continues to be an appropriate place for customized compounding of medications in today’s health care system.”

APhA policy on pharmacy compounding accreditation (2008)

APhA reaffirms the 1992 Compounding Activities of Pharmacists policy, which states that APhA affirms that compounding pursuant to or in anticipation of a prescription or diagnostic preparation order is an essential part of health care that is the prerogative of the pharmacist.
APhA supports compounding as defined by the Pharmacy Compounding Accreditation Board (PCAB) as a means to meet patient drug therapy needs.
APhA opposes compounding when identical medications are commercially and readily available in strength and dosage form to meet patient drug therapy needs.
APhA asserts that compounding is subject to regulations and oversight from state boards of pharmacy. APhA urges state boards of pharmacy to identify and take appropriate action against entities who are illegally manufacturing medications under the guise of compounding.
APhA supports accreditation of compounding sites by PCAB to ensure patient safety. APhA encourages state boards of pharmacy to recommend accreditation for those sites that engage in more than basic nonsterile compounding as defined by PCAB.
APhA supports the development of education, training, and recognition programs that enhance pharmacist and student pharmacist knowledge and skills to engage in compounding beyond basic, nonsterile preparations as defined by PCAB.
APhA encourages the exploration of a specialty certification in the area of compounding through the Board of Pharmaceutical Specialties (BPS).

(JAPhA NS48(4):470 July/August 2008) (Reviewed 2009)(Reviewed 2011)

Diana Yap

Senior Assistant Editor, Pharmacy Today

US Senate Posts Amended Pharma Serialization and Traceability Bill and Compounding Bill--Debated Expected Week of July 8, 2013

Entitled the "Pharmaceutical Quality, Security, and Accountability Act", this bill is the result of the merging of the compounding and drug security bills which were passed earlier in June by the Senate HELP committee.

The new consolidated bill includes certain amendments to the drug security bill previous passed by the HELP committee. Highlights include:

Provisions for Manufacturers to provide transaction history, information and statements in a single document, paper or electronic, to downstream trading partners
Verification procedures for Manufacturers, Wholesale Distributors and Dispensers in the event of potentially suspect product that should specifically include the standardized numerical identifier when verifying the package starting on or after the respective serialization deadlines for each industry segment

Debate on the bill in the full Senate is expected the week of July 8th. If the bill passes, it will have to be reconciled with the House drug security bill that differs on a few key components.

To hear a detailed breakdown of the serialization, transaction traceability, product verification and other provisions of both the Senate and House bills, you can watch a streaming replay of our analysis here: Federal Pharmaceutical Serialization and Traceability Webinar. Or, drop us a note and we'd love to discuss what the potential national legislation would mean to your business!

FDA Cracks Down On Online Pharmacies Selling Counterfeit Drugs Posted: June 30, 2013 Author: Jennifer Walker-Journey

The Food and Drug Administration (FDA) and Interpol are cracking down on online pharmacies for selling counterfeit or substandard medication, or selling drugs without appropriate safeguards. To date, 1,677 sites have been shut down and several others have received warnings. Fifty-eight people have been arrested and more than $41 million worth of illegal medications have been seized.

Many of these illegal pharmacies have names similar to legitimate pharmacies. For example, one of the online pharmacies the agencies have closed is Walgreens-Store.com, a play off of the legitimate Walgreens.com website.

Many of these sites advertise popular drugs such as Viagra and Celebrex. However, the drugs actually contain fake ingredients. The agencies say it is difficult to know how many deaths or serious reactions these errant medications have caused.

The National Association of Boards of Pharmacy recently assessed more than 10,000websites for online pharmacies and found that 97 percent fell short of meeting state and federal guidelines, and 88 percent did not require a valid prescription. Nearly half of the pharmacies reviewed sold medications that had not been approved by the FDA.

The National Association of Boards of Pharmacy features an approved list of online pharmacies. If in doubt, consumers can verify the authenticity of a site first, if the website asks for a valid prescription, and secondly if they have a licensed pharmacist available for consultation. The pharmacy should also be located in the United States and licensed in the state where the website is registered.

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Monday, July 1, 2013 Drug Companies Try to Ban Compound RX for Vets Today's Medical Monday deals with a critical issue to pet health care--a Vet's take on need for compounded drugs

Today's Medical Monday deals with a critical issue to pet health care.

My Meds Matter, a medical watchdog site with a specific interest in custom compounded medications, recently posted an alert about a proposal coming before the U.S. Senate. If passed, this proposal would effectively ban pharmacies from compounding medications prescribed by veterinarians to treat dogs, cats, and horses.
According to My Meds Matter, "customized medications can make all the difference is the world when these animals have a health issue.

The most egregious provision under consideration would limit the bulk ingredients that can be used in compounded medications to treat dogs, cats and horses to a positive list developed by the FDA.

There are no similar restrictions for elephants, giraffes, hamsters, other minor species— not even humans!

This could mean the elimination of important drug therapies that dogs, cats and horses depend on."

What's behind this push to ban compounding drugs? Apparently it's sponsored by the Animal Health Institute (AHI), a group created and funded by the big drug companies. Their member directory reads as a Who's Who of the world's major pharmaceutical companies: Abbot Laboratories, Bayer, Merck, Boehringer Ingelheim, Novartis, Zoetis
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AMA meeting: Compounding pharmacies need more oversight-■ The recommendations come as some physicians note it is critical for them to have compounded drugs available quickly. By PAMELA LEWIS DOLAN amednews staff — Posted July 1, 2013

Chicago Compounding pharmacies should comply with tighter restrictions, according to a report approved by the American Medical Association House of Delegates.

The house adopted a report with recommendations that compounding pharmacies comply with current U.S. Pharmacopeia and National Formulary compounding regulations concerning uniformity, quality and safety. The report also encourages state boards of pharmacy, which regulate the traditionalcompounding pharmacy industry, to require those pharmacies to adhere to sterile compounding practices. The report further recommends that large compounding pharmacies that introduce drugs into interstate commerce be regulated by the U.S. Food and Drug Administration.

The report, approved at the AMA Annual Meeting in June, was heavily debated during reference committee testimony, as some doctors argued that tighter restrictions could limit their access to compounded pharmacy products, placing patients at risk of not receiving necessary treatments in adequate time.

Compounding refers to the act of combining, mixing or altering pharmaceutical ingredients to prepare a customized medication for a patient. Traditional compounding is done by pharmacists for individual prescriptions. The AMA wants compounding facilities that mass produce compounded products to be recognized as “compounding manufacturers” that are subject to FDA regulations.

The reference committee said the report was prepared in response to widespread concerns about the safety of pharmacy compounding and the extent to which the products were deeply embedded in the U.S. health care system. The issue arose in 2012 when a meningitis outbreak that killed 58 people and sickened 700 others was linked to a compounded injectable product manufactured in Massachusetts.

Ophthalmologists share concerns

According to the FDA, compounding, “if done properly, can serve an important public health need if a patient cannot be treated with an FDA-approved medication.” Several ophthalmologists underscored this point during testimony when they spoke of the need for compounded medications to treat conditions such as macular degeneration, which could lead to loss of sight if treatment is delayed. Physicians buy these drugs to keep on hand in the office for such cases.

Sam Solish, MD, chair of the AMA Ophthalmology Section Council, said the section supported the concept of the report but said compounded drugs are essential to many ophthalmology practices, since some antibiotics needed for the eyes are available only in compounded form. Doctors must have those medications on hand to treat patients at the time of diagnosis, said Dr. Solish, who practices in Portland, Maine.