Why does Nancy Loomis, RPh have an active license with ZERO discipline recorded, not even a public complaint, when the pharmacy she owned and operated as a supervising pharmacist plead GUILTY to a FELONY?)

I  have previously posted about Signature Pharmacy which was located in Orlando, Florida  See links below.  Guess who was an owner in Signature Pharmacy and guess who is an owner in Olympia Pharmacy, which just initiated a volunteer recall.  You will want to read Dr. Ken Woliner's post below the previous post on this blog about Signature.

NY judge tosses convictions in Fla. steroids case

New details in DA's admonishment in Signature Pharmacy case

Orlando pharmacy pleads guilty to drug charge Signature Compounding Pharmacy of Orlando sold steroids 

Plea deal ends years-long steroids case No individual criminal charges against operators of former Florida pharmacy Times 

Signature Compounding case Lawsuit against Soares dropped Case facing Albany County prosecutor ends after pharmacy admits felony

Written by Dr. Ken Woliner, MD, ABFM

www.holisticfamilymed.com

Olympia Pharmacy is owned by Nancy and Stan Loomis (with Nancy Loomis, R.Ph. being the prescription department manager). These are the same owners of the defunct Signature Pharmacy that was the center of "Operation Which Doctor" that Albany County (NY) State Attorney prosecuted against this pharmacy and several "rejuvenation clinics"

Lowlite Investments Inc, doing business as Olympia Pharmacy in Orlando, Florida, has initiated a voluntary recall of all unexpired sterile drug products compounded by the pharmacy because of a lack of sterility assurance.

Lowlite Investments Inc, doing business as Olympia Pharmacyin Orlando, Florida, has initiated a voluntary recall of all unexpired sterile drug products compounded by the pharmacy because of a lack of sterility assurance.

"The recall is being initiated due to concerns associated with prior quality control procedures that impacted sterility," the company says in a press release posted May 29 on the FDAWeb site.

The affected product was compounded between December 17, 2012, and March 27, 2013. The recall includes all sterile products that Lowlite supplied to patients and offices of licensed medical professionals with a use-by date of September 25, 2013, or earlier.

A complete list of the recalled products, lot numbers and expiration dates can be found on the FDA Web site.

The recall is being conducted as a "precautionary measure," the company says. To date, they have not received any reports of injury or illness associated with the recalled product. However, "in the event a sterile product is compromised patients are at risk for serious and possible life threatening infections."

Lowlite is notifying customers by telephone, fax, or mail to return the products to the pharmacy.

Source found here

NABP Surveyors to Assist With New Jersey Compounding Pharmacy Inspections Under Contract With the State

Under a contract with the New Jersey Division of Consumer Affairs (Division) and the state’s Attorney General Jeffrey S. Chiesa, NABP will assist the Division with inspections of New Jersey pharmacies engaged in the practice of compounding. The planned pharmacysurveys will expand the Division’s already robust inspections of compounding pharmacies. As noted in a Division press release, New Jersey State Board of Pharmacy regulations hold compounding pharmacies to “stringent compounding standards, mirroring those of the U.S. Pharmacopeial Convention” and the Division’s inspectors have routinely inspected the state’s pharmacies to ensure compliance with regulations. The contract with NABP will enable New Jersey “inspectors to draw upon a greater body of expertise and experience to address this growing industry,” indicates Chiesa. Chiesa stated further that the Division “will act immediately on any violations that appear to threaten the public’s health and safety.” The expanded compounding pharmacy inspections have been initiated as a result of contamination issues discovered at Med Prep Consulting, Inc, in Tinton, NJ, and similar reports of contamination at compounding facilities in other states, as well as the fungalmeningitis outbreak linked to contaminated products compounded by the New England Compounding Center in Framingham, MA. New Jersey’s contract with NABP enables the Division to temporarily employ NABP inspectors on an as-needed basis. 

Similar inspection programs are under consideration in a number of other states, and NABP is in discussion with these states regarding how the Association can assist with these efforts to ensure the safety of compounded medications. In addition, NABP plans to establish an e-Profile for each pharmacy in the US, which will include verifications of licensure, disciplinary checks, and verification that a timely and robust inspection has occurred for each pharmacy, including those performing sterile and nonsterile compounding. The information in the e-Profiles for pharmacies will be sent proactively to boards of pharmacy for use in making licensure and registration determinations for nonresident pharmacies. 

A compounding inspection program conducted by NABP on behalf of the Iowa Board of Pharmacy was initiated in mid-December and is ongoing. More information about the Iowa compounding pharmacy inspection program and the information sharing network under development by NABP is included in the April 2013 NABP Newsletter article “Compounding Pharmacy Information Sharing Network Available to Boards Soon” (PDF).

quoted from here

May 30, 2013: Rep. Markey Introduces Bill to Support Compounding of Drug Products

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Rep. Markey Introduces Bill to Support Compounding of Drug Products
Bill Introductions-House
Copyright © Targeted News Service, 2013
2013-05-30

by KAREN NARAG

WASHINGTON, May 30 -- Rep. Edward Markey, D-Mass., has introduced legislation (H.R. 2186) to amend the Federal Food, Drug, and Cosmetic Act to "provide for the compounding of drug products."

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Contact: Eben Burnham-Snyder, Rep. Ed Markey, 202-225-2836

Follows Investigation Showing Lax Oversight of Compounding

WASHINGTON (May 23, 2013) – After his recent report showed that some states across the country are turning a blind eye to the risks of compounding pharmacies, Rep. Ed Markey (D-Mass.) today introduced new legislation to make compounding pharmacies safer for patients. The legislation will strengthen federal regulations for compounding pharmacies, especially high-risk sterile compounding and compounding pharmacies that ship drugs across state lines.

An investigation led by Rep. Markey and his Energy and Commerce Committee colleagues found last month that compounding pharmacies are going largely untracked, unregulated, and under-inspected by states across America, demonstrating the need for more federal oversight of the industry. Many of the risks from compounders were revealed following the 55 deaths and 741 illnesses in 20 states that originated from drugs created at the New England Compounding Center located in Rep. Markey’s Congressional District.

“We know some compounders are acting more like large drug manufacturers. We know that patients continue to be at risk for injury or death. And we know that some states are not doing their jobs to protect patients,” said Rep. Markey. “That’s why we need legislation that gives FDA more authority, while still allowing smaller mom-and-pop compounders to do their work for their patients.”

Massachusetts Governor Deval Patrick today praised Rep. Markey for his leadership on compounding pharmacy oversight. Governor Patrick has instituted a top-to-bottom review and proposed actions to increase the health and safety of compounding pharmacies in Massachusetts following the NECC tragedy.

“Congressman Markey’s legislation, coupled with the important steps we took at the state level, is critical to closing a regulatory gap created over the past several years for a variety of reasons,” said Governor Deval Patrick. “I commend Congressman Markey for his leadership. No one should live in fear that their medicine is unsafe.”

The legislation, the VALID Compounding Act, updates previous legislation introduced in 2012 by Rep. Markey. Original co-sponsors of the bill are Louise Slaughter (D-N.Y.), WM. Lacy Clay (D-Mo.), and Charles Rangel (D-N.Y.).

A one-pager on the VALID Act is available HERE, and the legislation includes the following main elements:

--Provides the FDA with sole regulatory authority over compounding pharmacies that engage in interstate commerce and high-risk sterile compounding without or in advance of a prescription. 

--Preserves State regulatory authority for traditional small compounding pharmacies. 

--Allows compounding pharmacies to compound drugs before receiving prescriptions for the drug provided that they register with the FDA and meet specified safety standards, and allows capable State regulators to oversee these pharmacies.  

--Increases communication between the States and federal government.

--Increases transparency to patients and consumers.

A full copy of the legislation can be found HERE and a section-by-section document HERE.

“This bill will save lives because it improves safeguards for all types of important medications made by the largest compounding pharmacies,” said Diana Zuckerman, PhD, president of the Cancer Prevention and Treatment Fund and National Research Center for Women & Families. “At the same time, it protects the thousands of small 'Mom & Pop' traditional compounders that some patients need.”

The legislation has been endorsed by the National Consumers League, National Research Center for Women and Families, Cancer Prevention and Treatment Fund, National Women’s Health Network, Our Bodies Ourselves, Union of Concerned Scientists, U.S. PIRG, Community Catalyst, The TMJ Association, and WoodyMatters. A copy of the endorsement letter can be found HERE

US House Shows Little Support for Senate Version of Compounding Bill

read this article here

The Sterility Risks in Pharmacy Compounding Can Be Limited, Not Eliminated, Experts Stress at USP Forum May 29th, 2013

to read this article click here

Louisiana Proposed Rule Changes: Some pharmacists concerned about proposed rule changes By Bill Lodge Advocate staff writer

Proposed changes in regulations could push some pharmacists out of the specialty medicine business in Louisiana, according to a Baton Rouge pharmacist with 37 years of experience.
Patricea Angelle, a compounding pharmacist in Baton Rouge, said the rule changes would impose an enormous cost burden on some compounding pharmacies and create serious problems for patients who depend on the medicines they provide.
Compounding pharmacies prepare medicines prescribed for patients with allergies or other negative reactions to some medications they need in order to recover from illness or injury.
Some of those special medicines may be needed by patients for whom other medications simply don’t work. Compounding pharmacists also prepare medicines that some physicians want to keep stocked at their offices.
Malcolm J. Broussard, executive director of the Louisiana Board of Pharmacy, said he hasn’t “heard from any pharmacies telling us the proposed rule would force them to close.”
If so, others will fill those gaps, Broussard said.
A public hearing on the pharmacy board’s proposals is scheduled for 1 p.m. Thursday at the board office, 3388 Brentwood Drive.
The proposed rule changes in Louisiana follow an incident late last year in which dozens of recipients of medicines from a compounding pharmacy in Massachusetts contracted fungal meningitis and died.
The Louisiana Board of Pharmacy declared an emergency in January, and members announced they planned to adopt a rule that would bar the state’s compounding pharmacists from deriving more than 10 percent of their business from the sale of medicines by purchase order to physicians for use at their offices.
“The quality and safety standards for products made pursuant to a purchase order are ordinarily more stringent than the quality and safety standards for preparations made pursuant to a patient-specific prescription,” Broussard, said in an email exchange this week.
“When pharmacies make products pursuant to purchase orders in compliance with the less stringent standards applicable to patient-specific prescriptions, there is a potential risk,” Broussard added. “The proposed rule is an attempt to mitigate that risk by limiting such activity to no more than 10 percent of a pharmacy’s activity.”
In Washington, D.C., Sarah Dodge, the International Association of Compounding Pharmacists’ vice president for government affairs, said such rules seem arbitrary.“That concerns us,” Dodge added.
Dodge explained that one proposed federal law calls for greater controls on compounding pharmacies that send sterile compounds across state lines to recipients who are not patients.
Inside one state’s boundaries, Dodge said, “What we prefer is that the state allow what has been usual for (physicians’) office use.” She said her organization does not support an arbitrary cap.
“The federal proposal is far more palatable than the Louisiana proposal,” Dodge said.
Broussard said, “In the event a pharmacy is currently preparing more than 10 percent of itsactivity pursuant to (physicians’) purchase orders, that pharmacy will need to make a business decision.”
continue reading here

FDA to Once Again Allow Import of Unapproved Drugs to Solve Shortages

29 May 2013

By Alexander Gaffney, RF News Editor

Responding quickly to congressional pressure and the needs of critically ill neonates, the US Food and Drug Administration (FDA) today announced that it would allow the import of several types of [Read More...] 

Edwards, Hospira Warn Investors of Receipt of FDA Warning Letters

30 May 2013

By Alexander Gaffney, RF News Editor

Two major life sciences companies, Hospira and Edwards Lifesciences, have separately warned their respective investors about their receipt of Warning Letters from the US Food and Drug Administration [Read More...] 

Is it True: Pharma Trying to put Vet Compounding Pharmacies Out of Business?

ig Pharma Trying to put Vet Compounding Pharmacies Out of Business

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Proven ingredients mixed to create effective medicines to become illegal if big pharma gets it's way. These money hungry sluts want to control everything related to the drug market. No doubt medication for people will be next!

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You have used compounded medications for your pet, and those medications are under attack by the big drug companies.

The big drug companies are trying to intrude on your relationship with your veterinarian and your pets. Last month, a provision they proposed was temporarily removed from a Senate bill (S.959) that would have greatly limited your vet’s ability to prescribe compounded medication for dogs, cats and horses.

This provision allowed the FDA to severely restrict compounded medications for dogs, cats and horses. Treatment options for elephants, giraffes, hamsters and other “minor species” were not limited. Yes, you are reading this correctly. The proposal actually targets family pets and horses. Why? Because that’s where the money is.

The proposal is the work of the Animal Health Institute (AHI), a group created and funded by the big drug companies. They want your money. You and your vet want the best possible care for your pets.

We know that many pet owners rely on compounded medication to treat serious and chronic conditions in your pets. They can be literally lifesavers. But now, we hear those corporate interests who would put profits before pets are hoping to insert this provision back in as early as late June when S.959 is debated on the Senate floor. As one AHI lobbyist was quoted in the trade press: “We hope our absence from the bill is temporary.” What’s more, the same drug company lobbyist criticized the “permissiveness” of the original language restricting treatment options for your pets. Have they no shame? 

We can’t let that happen. The consequences are too severe. Please take action today to tell Congress to leave medical decisions about dogs, cats and horses to you and your veterinarian.

http://www.mymedsmatter.com/?vvsrc=/Camp...95/Respond


Animal Health Institute - Big Pharma lobby group. Located 1000 feet from the White House.

This post is quoted from here

http://www.ahi.org/about/member-directory/

http://maps.google.com/maps?client=safar...IgBEPwSMAA

Update: Texas Board of Pharmacy Is Seeking Pharmacits to Assist in Disciplinary Proceedings??? Are there Going to Be So Many Their Lawyers Can't Handle Them? Are Maybe so Complex and Relating to Compounding That It Makes More Sense for Pharmacists to Handle Them?

1. TX Pharmacy Board ‏@txpharmacyboard 15h

   TSBP is seeking pharmacists to assist in disciplinary proceedings, including case preparation and presentation for... http://fb.me/U8JMmgiQ 
   
   Here is what the FB link says:
   
   

   TSBP is seeking pharmacists to assist in disciplinary proceedings, including case preparation and presentation for non-therapeutic dispensing and negligent practice cases. To learn more about this opportunity to advance professional care and concern for the practice of pharmacy, contact Caroline Hotchkiss at 512/305-8046.

KUDOS--This Article MAKES AN EXCELLENT POINT THAT HAS BEEN MADE SEVERAL TIMES ON THIS BLOG: Make pharmacy regulations meaningful May 28, 2013 10:12 PM

OUR VIEW

How much clearer does it have to be? The laws that are meant to ensure compounded medications are safe are not getting the job done.
Last year’s outbreak of fungal meningitis caused by contaminated medicine killed 55 patients, including 15 people in Tennessee. Hundreds more were sickened.
And yet, another compounding pharmacy, this one in West Tennessee, has been identified as the likely source of a new spate of infections in North Carolina and Illinois.
Facilities in 13 states overall received supplies of the medicine.
Main Street Family Pharmacy LLC in Newbern has now recalled all its sterile products. Tennessee health officials on Tuesday released the names of seven Tennessee facilities that received the drug.
Main Street shipped the medications about two weeks after state inspectors found violations at the pharmacy in November. Inspectors concluded that “the processes they were following at the time did not indicate there was any problem,” says Terry Grinder, interim director of the Tennessee Pharmacy Board.
How can that be, since the inspection helped lead to Main Street’s top pharmacist being fined and placed on two years’ probation; 109 medications on the pharmacy’s shelves were found to be outdated, and 11 prescriptions were not written on tamper-resistant paper as required under state law?
Main Street also was cited in 2011 for having expired medications used for drug compounding; sterilization equipment out of compliance; and shipping compounded drugs directly to physicians’ offices without patient-specific prescriptions, a direct violation of state law.
The state did not shut down the pharmacy then, either.
So maybe these dangerous problems continue because compounding pharmacies know that the consequences for breaking the rules are minor, if they are imposed at all.
And let’s not pretend that health officials and pharmacies do not understand the risk to patients’ safety if their medications are not compounded under strictly controlled conditions and made for specific patients. The deadly outbreak caused by the New England Compounding Center unfolded before Main Street was inspected in November.
Then, early in 2013, the Tennessee General Assembly acted irresponsibly by approving a loophole in the specific-patient prescription requirement. It was suggested that the risk of shortages outweighs the risk of contamination.
That is an important discussion to have, but why are the only options ample supply or lax safeguards? Shouldn’t compounding pharmacies ensure that they are adequately staffed and supplied without resorting to shortcuts?
Pharmacists are not physicians, but they are their partners in care. Shouldn’t they also adhere to the key tenet, “First, do no harm”?
quoted from here

NABP Testifies at US House Subcommittee Hearing Regarding Support for Federal Legislation to Distinguish Between Compounding and Manufacturing May 29, 2013 6:15 pm

May 29, 2013 6:15 pm Topics: Compounding

NABP expressed its support for federal legislation that would distinguish between compounding and manufacturing, in testimony (PDF) presented at a United States House subcommittee hearing on May 23, 2013. The hearing, “Examining Drug Compounding” was held to provide US Committee on Energy and Commerce Health Subcommittee members an opportunity to hear testimony from Food and Drug Administration (FDA) and health care experts regarding the importance of drug compounding to patients and the current regulation of compounding on the federal and state levels. In its testimony, NABP noted that the clarifications in the proposed Pharmaceutical Compounding Quality and Accountability Act (S 959) regarding the distinction between compounding and manufacturing “provide a safe and equitable environment for both compounding and manufacturing to occur in the best interest of the patient.” The Association stressed that the distinction between compounding and manufacturing is “critical to maintain the present authority of the states and address one of the contributing factors to the NECC [New England Compounding Center] crisis, specifically, the ambiguous authority between the states and FDA.”  The proposed legislation also specifies that a “compounding manufacturer” cannot be licensed as a pharmacy, and NABP notes that this provision is “essential to distinguishing between state-regulated compounding and FDA-regulated manufacturing.”
continue reading here

News Release: FLORIDA DEPARTMENT OF HEALTH PROVIDES UPDATE ON MULTISTATE EPIDEMIOLOGICAL INVESTIGATION ASSOCIATED WITH STEROID INJECTIONS

Link to press release can be found here 

Thank you to Kenneth Woliner, MD, ABFM, www.holisticfamilymed.com, for providing the link to the press release.

13 new illnesses linked to TN drug compounder May 29, 2013 5:45 PM

Written by

Walter F. Roche Jr.

The Tennessean

The number of adverse events suspected of coming from steroid medications from a Tennessee drug compounder has nearly tripled with 13 new cases reported by the Florida Health Department.

In a statement released Wednesday, Florida officials said adverse reactions were limited to skin abscesses and did not involve any life-threatening conditions. The disclosure boosts the total number of cases in the growing cluster to 20, including five in Illinois and two in North Carolina.
According to Florida health officials, the victims were all given intramuscular injections of methylprednisolone acetate shipped from the Main Street Family Pharmacy in Newbern, Tenn. Four Florida facilities received the suspect drugs.
No adverse reactions have been reported in Tennessee, where seven clinics got the drugs. Among them was Axis Medical Clinic in Robertson County.
Dr. Paul Yim, who has been operating the clinic in White House for 15 years, said in a telephone interview Wednesday that he is contacting an estimated 200 patients who were injected with the steroids.
“We’ve not had any complaints or reports of infection,” Yim said. “None at all.”
The drug is the same one blamed for a nationwide fungal meningitis outbreak that has taken the lives of 15 Tennessee patients and 55 nationwide. Those tainted spinal steroids were shipped around the country by the now-bankrupt New England Compounding Center in Massachusetts.
Yim said Axis Medical is contacting any patients who got shots with methylprednisolone acetate over the past six months. He said he has been working with the state health department to collect information on the patients, including their age, the date of the shots and the date of the last visit.
He said Main Street Family Pharmacy was suggested to him by a medical supply firm and he has been buying drugs from the firm for about two years without any problems. He described Main Street sales staff as “pleasant and professional.”

continue reading here

American Academy of Ophthalmology Issues Statement on Provisions to Pharmaceutical Compounding Quality and Accountability Act

WASHINGTON, May 29, 2013 /PRNewswire-USNewswire/ -- As legislation to toughen oversight of compounding pharmaceuticals goes to the Senate floor for further debate, ophthalmologists are warning Congress of the unintended consequences of proposed provisions to the bill that require a named prescription for many uses of compounded drugs. While it is largely supportive of the higher safety standards bill S. 959 (the Pharmaceutical Compounding Quality and Accountability Act) would impose on compounding pharmacies and manufacturers, the American Academy of Ophthalmology is seeking exemptions from Sections 503A(d)(4) for biological products and 503A(d)(3) for marketed drugs to allow for continued office use of safe, sterile compounded ophthalmic drugs without a specific patient designation. The Academy points out that there is no evidence to suggest that labeling a drug with a patient's name increases the safety of the repackaging process.

(Logo: http://photos.prnewswire.com/prnh/20130405/MM89329LOGO)

"Safe, sterile compounded medications have long been essential tools available to ophthalmologists for urgent treatment of eye diseases and conditions, benefitting millions of patients," said David W. Parke II , M.D., CEO of the American Academy of Ophthalmology. "The American Academy of Ophthalmology shares the concerns of Congress regarding the need to ensure that these products are compounded in the most sterile and safest manner possible in order to protect public health. As part of that process, however, the Academy urges the continued availability of these sight-saving medications without requiring patient-specific prescriptions, as time is often a critical element in preventing irreversible blindness. The Academy believes that compounding can be done in a safe and efficacious manner and support Congress in ensuring the safe availability of these medications for eye physicians and surgeons and the patients they serve."

continue to read here

New Compounding Pharmacy Scandal in TN May 29th, 2013 // 1:01 pm @ jmpickett

Last month, Tennessee passed a law that eased the restrictions on the state’s compounding pharmacies. Now FDA is looking into seven cases of patients suffering adverse events after they were injected with possibly contaminated drugs that were compounded by a TN pharmacy.
That is why Main Street Family Pharmacy is doing a recall of all of its sterile drug products. Most of them are injectable drugs. It appears that the drugs that are related to the adverse events have methylprednisolone acetate, which is the drug that led to the killer outbreak of fungal meningitis last year.
That outbreak has 740 cases and led to 55 deaths so far. It is the most grave public health crisis in the US in 40 years, and was traced to the New England Compounding Center. That scandal has led FDA to scrutinize drug compounders more closely.
For example, in 2013, FDA started an aggressive effort to do inspections of dozens of drug compounders in many states. There have been some product recalls, too. FDA wants Congress to give them more oversight authority, as well.

• May 30 – Audit Your Lab Like an FDAer
• June 12 – Avoid Warning Letter Disasters with a Strong cGMP Quality Agreement

However, Tennessee last month passed a law to cut down on drug shortages by letting compounders make more drugs and also avoid reliance on compounders out of state. This law also would allow compounders in TN to make/dispense drugs without a specific prescription for a patient. Some experts think this is dangerous.
Records show that Main Street Family Pharmacy shipped product to AL, AR, CA, FL, KY, IL, LA, MS, NM, NC, SC, TN, and TX. So far, patients in NC and IL have infections.
It is not clear how many patients got injected with the tainted drugs, but the TN Department of Health says that the firm had a license as a manufacturer, wholesaler and distributor in 2010.
quoted here

Press Announcements FDA announces import of injectable nutrition drugs

Press Announcements FDA announces import of injectable nutrition drugs

Meet the career con man who made a fortune selling illegal pharmaceuticals online—and pulled off a federal sting that forced Google to pay $500 million.

read the story here

Contaminated injections traced to IL clinic

Contaminated injections traced to IL clinic

Question of the Day: May 29, 2013 What are the differences between "traditional Mom and Pop" compounding and "non-traditional manufacturing" compounding? (Thank you Dr. Woliner for the detailed and indept answer you wrote)

Written by:

Kenneth Woliner, MD, ABFM
Boca Raton, FL
www.holisticfamilymed.com

BACKGROUND

Traditional compounding is done every day, to some extent, at regular chain pharmacies. One example is that FLAVORx is added to liquid medicines (often given to children who can't swallow tablets) to make them taste better (http://flavorx.com/). Another is the various versions of "magic mouthwash" (combinations of viscous lidocaine, maalox, mylanta, benadryl, tetracycline, nystatin, prednisolone, etc) used to treat mouth sores from cancer chemotherapy, apthous ulcers, and even the "burning tongue syndrome" (http://www.drotterholt.com/magicmouthwash.html).


MAINSTREAM PHARMACIES

Admittedly, "big chain pharmacies" such as Walgreens, CVS, Target, Costco, WalMart, etc - aren't efficiently set up to do compounding on a regular basis, preferring to do a "volume business" of using their "pill counting machines" and registered pharmacy techs to take stock bottles of 1,000 pills and transfer them into individual pill bottles of 30 or 60 pills each, handing them to the patient, and having patients sign the form that says "pharmacy counseling offered but refused by patient". From speaking with pharmacists who work in these big chain pharmacies, I understand that this "mill-like atmosphere" makes it very difficult for the pharmacist to have any interaction with the patient, and has turned many pharmacists into "clerks" that fill orders, where they will "hit the green button" verifying that the prescription written is actually the one being dispensed.  When they do get a "magic mouthwash" compounded-type prescription, it slows them down from their clerk-like responsibilities. Hence, a lot of pharmacists do not like to do compounding.


MOM AND POP PHARMACIES THAT DO COMPOUNDING

Not every pharmacy is "part of the corporate machine". There are quite a few "mom and pop" pharmacies out there, and they do thrive by providing great customer service - e.g. they know their patients by name, they're friendly, they might do deliveries (especially for home-bound senior citizens), etc.  Some of these pharmacies are "franchisees" (but locally owned) with a familiar name (e.g. Rexall, The Medicine Shoppe, etc.). Others have a friendly name of the owner pharmacist or town the pharmacy is located in (e.g. "Arthur's Drugs", "Boca Apothecary", etc.).  Part of their "customer service" is to do compounding for their patients, based upon individual prescriptions. They rarely do "anticipatory compounding", of making things up ahead of time. The volume for each type of medicine isn't there for that. It is expensive to do things this way, but because the pharmacy runs low overhead in other ways (no corporate profits), or charges more for each compounded prescription, these mom and pop pharmacies stay in business, and seem to do quite well. What is more important for the pharmacist is the quality of their job (the ability to interact with patients, to use their brain rather than being just a clerk), rather than their paycheck and 401K matching retirement plan the chain pharmacy would have paid them.


SPECIALIZED COMPOUNDING PHARMACIES THAT SERVE THE "LOCAL AREA"

It is a niche market to do compounding, and to "do it right" and to do it efficiently. Pharmacists that love to do compounding go to conferences and read journal articles specifically to learn how to do compounding. They frequent bulletin boards on-line and "trade recipes" of how to safely make different to compound different medicines. They speak with their prescribing physicians and veterinarians, and help "trouble-shoot" solutions with patients with particular problems that are difficult-to-treat such as Multiple Sclerosis, Fibromyalgia, and Chronic Fatigue Syndrome. They realize that allergies to food dyes and other inactive ingredients in medications is a problem for many patients, and they compound allergy-free formulations. They may focus on a niche such as veterinary compounding (small animal, large animal, or both), menopause management (with bioidentical hormone replacement therapy), or pain (topical compounded creams that don't have systemic side effects if sedation, low dose naltrexone, etc).

These pharmacies "may occasionally" mail a prescription across state lines. A patient may be a snowbird, and doesn't want to transfer a prescription from one pharmacy to another. A patient may move away, but like the pharmacy so much, he/she may prefer to use that pharmacy rather than find a local pharmacy. But for the most part, their business is a local one, serving local prescribers and their patients.


NON-TRADITIONAL COMPOUNDING SERVING PATIENTS IN STATES FAR AWAY FROM THE PHARMACY

There is a demand for compounded drugs. Most of it is generated by patients that "do better" with a compounded prescription that is customized to the patient. However, a lot of the demand is generated by the pharmacies themselves. These "larger scale" compounding pharmacies aggressively market themselves nationally by sponsoring exhibit hall booths at conferences that teach "anti-aging" and "alternative medicine" type courses. Some offer to sell these compounds to the physician at a "wholesale price" and then have the physician sell these drugs to the patient at a retail price, even though this is illegal in multiple aspects (patient-brokering, split-fee/kickbacks, etc). Some will let a physician/veterinarian dispense these drugs to the patient for the patient (or its owner) to administer to themselves at home, even though this is also illegal (doing so would make the pharmacy a manufacturer, manufacturing an unapproved new drug).

These "non-traditional" compounders, in part due to their marketing activities, do have enough volume to do "anticipatory compounding" before a prescription is received. This is good and bad. The good: turn-around time from when a prescription is received and when it can be filled is shortened, the cost of the prescription could be less (though not necessarily, especially if there is "restriction of the patient's choice of pharmacy due to the split-fee/kickback/patient brokering agreements mentioned above), and perhaps, quality control could be better because, with batch production, samples can be independently tested for potency and sterility.  The bad: "anticipatory compounding" is for all practical purposes, a loophole to do manufacturing without a manufacturer's license (or the patient-protection regulation that goes along with it). Hence we have "manufacturers in pharmacy clothing" such as NECC, Franck's, and ApotheCure that have operated beyond the scope of pharmacy practice, made mistakes because they were not following all the rules/procedures a manufacturer is supposed to be doing, and patients have died (or been blinded, or suffered other complications) as a result.


SUMMARY

I'm not saying that all "non-traditional" compounders are evil. I do prescribe compounded medications, and, with the patient's choice of pharmacy intact, often call/fax prescriptions to these non-traditional compounding pharmacies. I sometimes even recommend one pharmacy over another (e.g. one pharmacy is well known to do ophthalmic preparations well; another pharmacy is well known for its ability to service patients with Lyme disease, etc). However, I don't dispense compounded drugs from my office, and I don't make a dime off the medications themselves.

I am also more cautious than ever of which pharmacies I recommend and those I don't recommend. If a pharmacy offers me a kickback (overt or covert, directly or indirectly), I will refuse to use them. If a pharmacy is willing to manufacture a prescription in a form that is not bioavailable (such as compounded oral Sporanox/itraconazole; sublingual HCG), I consider the supervising pharmacist to be someone who doesn't care about the welfare of the patient, but merrily someone who wants to sell product (Restore Health Pharmacy in Wisconsin just got disciplined for that exact reason). And a pharmacy that is willing to scam patients with fraudulent treatments, whether it be HCG Diet plans or Laetrile cancer remedies, again, I have no respect for them. I would hope that other prescribers would have the same sense to refuse to do business with these types of pharmacies, but unfortunately, too many physicians don't do their due diligence when looking at the pharmacies they use.

Compounding is important to patients. Compounding should be allowed to continue. But these pharmacies that do "anticipatory compounding" and/or routinely ship prescriptions across state lines, should have a manufacturing license and follow those regulations as well. Going to national conventions and seeing which pharmacies are advertising their wares is perhaps the biggest tipoff and easiest way for the FDA to identify which pharmacies need to be looked at more closely.

2013 NABP Meeting brochure--Talk Scheduled on Compounding-"Compounding the Situation"

2013 NABP & AACP District 6, 7 & 8 brochure (DOC)

Alaska Board of Pharmacy Minutes for February 28-March 1, 2013 Meeting Contains Lot of Discussion On Compounding Issues

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Pharmacist Salaries Hit $117K and Keep Climbing

Pharmacist Salaries Hit $117K and Keep Climbing

How the Pharmacy Industry Ch-ch-changed in 2012

How the Pharmacy Industry Ch-ch-changed in 2012