The Florida Department of Health (FDOH) has stated that it cannot divulge if Franck’s is being investigated at this time. If an investigation is being done and the pharmacy is believed to pose an immediate threat to patient safety, FDOH could issue an emergency suspension order (ESO) to immediately suspend the pharmacy’s license. FDOH can't confirm whether they are investigating Franck's or any pharmacy until 10 days after the alleged investigation and only if probable cause is found.
To read more about Franck's current issues with its compounding pharmacy, see the following:
Associated Press. “CDC Links Eye Infections to Troubled Florida Pharmacy.” Fox News.com. (May 04, 2012), click here.
CBS News Staff. “Rare Fungal Eye Infections Tied to Fla. Pharmacy, CDC Warns.” CBS News. (May 04, 2012), click here.
Medina, Carlos E. “Eye Infections Linked to Ocala’s Franck’s Compounding Lab.” The Gainesville Sun. (May 03, 2012), click here.
WFTV. “Ocala Pharmacy Blamed for Dozens of People Suffering Vision Loss.” WFTV.com. (May 04, 2012), click here.
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Saturday, May 19, 2012
Friday, May 18, 2012
Why We Need and Must Have Compounded Medications
In the wake of the tragic deaths in Franck's (Florida), Apothecure (Texas) and Meds IV (Alabama), it is important to not lose sight of the fact that we need and must have compounded medications. If these medications were not available, some patients (both humans and animals) would suffer and some could die. This was explained by Loyd V. Allen, Jr., Ph.D., R.Ph., Editor-in-Chief, International Journal of Pharmaceutical Compounding, when he testified on April 19, 2007, before the U.S. Senate Special Committee on Aging in Washington, DC. During his testimony he explained:
Millions of Americans have unique health needs that off-the-shelf prescription medicines cannot meet. For many of them a customized, compounded medication prescribed by licensed physicians or veterinarians and mixed by trained, licensed compounding pharmacists are the only way to better health. If customized medicines were not available, some of our most at-risk patients would needlessly suffer and some would die.
Allen also gave excellent examples of those who rely on compounded medications:
• Infants and children: Compounding pharmacists can transform medicines fromThese are important examples of why we need and must have compounded medications in the United States. The problems in the tragic cases do not suggested that the practice of compounded medications must be stopped; instead, the tragedies shows that the rules and regulations relating to compounding need to be complied with by pharmacies, doctors, veterinarians and enforced by state boards of pharmacy, state boards of medicine, state veterinary boards and the United States Food and Drug Administration. To read the entire transcript of Dr. Allen's testimony, click here.
hard-to-swallow pills intended for adults into syrups, elixirs, suspensions, and
emulsions for children, at the request of physicians. Flavors offered by
compounding pharmacists can make drugs more palatable to children. In
addition, premature infants often rely on lifesaving and life-sustaining drugs made
only in compounding pharmacies.
• Hospital patients: Many, if not most, of the lifesaving intravenous drugs given in
hospitals and clinics are compounded. Because hospital patients are often on
multiple medications, compounding them into one treatment saves the hospital
personnel time and the patient multiple injections or administrations.
• Cancer patients: Cancer treatment often involves special mixtures of cancer drugs
that are compounded pursuant to a doctor’s prescription. Pharmacists can
combine multiple drugs into one treatment, leading to shorter administration times
for cancer patients.
• Senior citizens: Elderly patients often have difficulty with traditional dosage
forms, such as pills taken orally. Compounding pharmacists create alternate
methods of delivery, like transdermal gels, to make it easier for the elderly to take
their medicine.
• Pets: Animals come in all shapes and sizes, so one-size-fits-all pharmaceuticals do
not always meet their needs. In many cases, a compounded medication may be
necessary for a non-food animal to be satisfactorily treated.
• Patients with allergies: Patients who are allergic to a preservative, dye, flavor or
other ingredient in commercial products can have their doctor write a prescription
for a compounding pharmacist to customize the same medication without the
offending ingredient.
• Menopausal women: Many women experience significant pain and discomfort as
their bodies’ progress through menopause. Doctors prescribe bioidentical
hormones for patients for whom synthetic hormone treatments may be ineffective
or produce undesired side effects. Several bioidentical hormone products are
available in FDA-approved, one-size-fits-all formulations from pharmaceutical
companies. However, physicians may determine that their patients have unique
needs that warrant prescribing a different compounded hormone treatment. This
often allows patients to take the smallest amount of a given hormone preparation
to treat their symptoms, in conjunction with the recommendation provided by the
Women’s Health Initiative study.
• Patients who require non-traditional dosage forms: Many patients are unable to
take medications orally or as injections – the traditional dosage forms for
manufactured drugs. Compounding pharmacists can create alternate methods of
delivery, like ointments, solutions or suppositories, to fit these patients’ unique
health needs. The pharmaceutical industry supplies only limited strengths of
drugs, which some patients cannot tolerate. It is often necessary for a doctor to
request a different strength of a drug for a patient through compounding.
• Patients who rely on discontinued drugs: Pharmaceutical manufacturers have
discontinued thousands of drug products over the years, due to low profitability.
For certain groups of patients, these were very effective, important, and
sometimes life-saving medications. Such medications are now only available if a
doctor prescribes them to be compounded.
• Hospice patients: End-of-life therapy involves the compounding of many different
and unique dosage forms to allow patients to live out their lives free of pain and
discomfort. Many combinations of drugs are prescribed by doctors and used for
these patients who cannot swallow medications and who don’t have the muscle
mass that is required to receive multiple injections each day. Compounding
pharmacists can provide alternate delivery methods such as oral inhalation, nasal
administration, topical, transdermal or rectal use.
Franck's had to Answer Why It had Not Paid Penalties
A recent article entitled Trouble ahead for Franck's, Second Drug Controversy in Three Years could Spell Problems for Ocala Compounding Law, written by Carlos E. Medina and published on May 4, 2012, points out that Franck's has not satisfied state penalties handed down in the settlement after the 2009 incident that killed the 21 horses and Franck's recently had to appear before the Florida State Board of Pharmacy to answer why it had not paid the penalties. The articles states:
But even as the company deals with the latest investigation, it still has not satisfied state penalties handed down in a settlement after the 2009 incident that killed the 21 horses.The Florida State Board of Pharmacy recently brought Franck's before them to answer for not paying the penalties.
On May 1, the board ordered the lab to pay more than $14,387.21 in original penalties, plus another $2,000 fine and $1,000 in administrative costs for not abiding by the first settlement. The company has 90 days to pay the fines.
In the 2009 case, Franck's was cited by the state Department of Health for numerous violations of Florida law covering pharmacies.
To read the entire article, click here.
Settlement Agreement Between Franck's and Florida State Department of Health
A draft of the Florida State Department of Health board meeting minutes for April shows more trouble for Paul Franck and Franck Pharmacy. To read the entire draft of the minutes, click here. Here are the disciplinary actions against Franck.
TAB 3 DISCIPLINARY CASES – John Truitt, Assistant General Counsel
A. SETTLEMENT AGREEMENT– APPEARANCE REQUIRED CASES
A-1 Paul Wayne Franck, PS 17342, Ocala, FL
Case No. 2008-17152 – PCP Powers/Jones
Respondent violated:
Count One: Section 465.016(1)(e), F.S., by violating Sections 499.01(1) and 499.005(22), F.S., by failing to obtain a prescription drug wholesaler’s permit or a retail pharmacy drug wholesaler’s permit prior to engaging in wholesale distribution of prescription drugs.
Count Two: Section 465.016(1)(e), F.S., by violation of section 499.005(22)m by failing to obtain a permit prior to operation as a prescription drug repackager as required by section 499.01(1)(b).
Respondent shall be present. Respondent shall pay a fine in the amount of $2,000 and costs in the amount of $427.17. Respondent shall complete a 12 hour Laws and Rules CE course.
Respondent was present and sworn in by the court reporter. Respondent was represented by William Furlow.
Motion: by Weizer, seconded by Fallon, to accept the Settlement Agreement. Motion carried.
A-2 Francks Lab, Inc, PH 19761, Ocala, FL
Case No. 2008-16979, 2010-16555 – PCP Powers/Jones, Garcia/Weizer
(2008-16979) Respondent violated:
Count One: Section 465.016(1)(e), F.S., by violating Sections 499.01(1) and 499.005(22), F.S., by failing to obtain a prescription drug wholesaler’s permit or a retail pharmacy drug wholesaler’s permit prior to engaging in wholesale distribution of prescription drugs.
Count Two: Section 465.016(1)(e), F.S., by violation of section 499.005(22)m by failing to obtain a permit prior to operation as a prescription drug repackager as required by section 499.01(1)(b).
(2008-16979) Respondent shall be present. Respondent shall pay a fine in the amount of $2,000 and costs in the amount of $750.97.
Respondent was present and sworn in by the court reporter. Respondent was represented by William Furlow.
For the first Settlement Agreement:
Motion: by Ms. Mullins, seconded by Dr. Fallon, to dismiss the case. Motion carried with Dr. Griffin opposed.
(2010-16555) Respondent violated Section 456.072(1)(k), F.S., by failing to perform any statutory or legal obligation placed upon a licensee.
(2010-16555) Respondent shall be present. Respondent shall pay a fine in the amount of $2,000 and costs in the amount of $80.67.
For the second Settlement Agreement:
Motion: by Dr. Fallon, seconded by Ms. Glass, to accept the Settlement Agreement. Motion carried.
Article: Liability of Veterinarians When Using Compounded Drugs
The following article appearing in the November 3, 2011, edition of Veterinary Practice addresses the liability issues a veterinarian may be exposed to when violating the law regarding compounded medications.
Legal Exposure Might Not be Worth the
Savings
Using a compounded drug instead of an FDA-approved
animal medication could open a veterinarian to legal exposure if the animal has
a bad outcome.
By Marie Rosenthal, MS
For Veterinary Practice News
Posted: Nov. 3, 2011, 2:35 p.m. EDT
Some veterinarians believe they are helping clients
reduce costs by ordering compounded drugs instead of medications approved by
the U.S. Food and Drug Administration.
But there’s a reason compounded drugs are cheaper than
FDA-approved medications, pharmaceutical companies say. Compounding pharmacies’
quality-control procedures are rarely as stringent or comprehensive as the good
manufacturing practices required by the FDA for approved products. Therefore,
the safety and efficacy of compounded drugs are not guaranteed.
In a case of therapeutic failure of a compounded
product when an FDA-approved medication is available, the amount the
veterinarian saves the client might turn a competitive advantage into a serious
disadvantage. That prescription could leave the veterinarian exposed to legal
liabilities because the FDA does not test or approve compounded drugs.
Liability Dangers
“Many times veterinarians don’t understand that they
are the first in line in liability in the event that a compounded product goes
bad,” says Denise E. Farris, Esq., owner of Farris Law Firm LLC in Kansas City,
Mo.
“If there is an adverse reaction, he or she is liable
to the client for veterinary malpractice. The liability coverage may not cover
that activity because most policies do not cover ‘gross negligence’ or
‘intentional acts.’
“If a veterinarian is prescribing a compounded
product, the veterinarian could be charged with negligence because he or she
knew or should have known that the product was untested and its efficacy was
not proven,” she says.
She adds that there can be further liability if a
client is not fully informed about the risk of using the compounded substitute.
Several studies have reported quality problems with
compounded drugs, including subpotency, superpotency and contamination. In
2006, 33 percent of active pharmaceutical ingredients for human drugs used by
compounding pharmacists or finished compounded human drugs failed an FDA test,
primarily because of sub- or super-potency or a lack of uniformity. Potency
ranged from 67.5 percent to 268.4 percent of the amount of drug declared on the
product labeling, according to the FDA.
In its report, the FDA says, “The results of the
survey suggest that problems with the quality of compounded drugs occur
throughout the country.”
Finding a Place
This is not to say that compounded products do not
have a legitimate place in equine medicine. They do, the FDA acknowledges, but
it says that place is narrow.
In a 2006 warning letter to a veterinary compounding
pharmacy, the FDA wrote: “The drugs that pharmacists compound are rarely
FDA-approved and thus lack an FDA finding of safety and efficacy.”
The FDA regards traditional compounding as the
extemporaneous combining, mixing or altering of ingredients by a veterinarian
or a pharmacist as ordered by a veterinarian (or physician) to create
medication tailored to the specialized needs of an individual patient.
“Compounding is a very narrow, specific field,” says
Jeffrey T. Berk, VMD, who practices equine medicine at Equine Medical
Associates in Lexington, Ky. “A compounded product is supposed to be produced
for a particular patient, for a particular condition, at a particular time and
is obviously tailored for a unique need for which there is no approved
product.”
Many clients think that compounded drugs are generic
substitutions of a name-brand medication, but they are not. By law, compounding
pharmacies are not allowed to make large quantities of medications using
commercial-scale equipment—that could be construed as manufacturing drugs
without a license.
Although the compounding pharmacist is supposed to use
FDA-approved active ingredients when compounding a drug, the final compounded
drug formulation is not an FDA-approved medication because it has not been
tested for efficacy, safety, potency, sterility, dosage or even stability.
Approvals
Generic drugs are subject to FDA oversight just as
brand-name medications are, but compounded drugs are not. A pharmaceutical
company that wants to make a generic version of a brand-name medication must
prove to the FDA that the generic is equivalent in all characteristics to the
brand-name medication. The generic drug must also meet the same manufacturing
quality control requirements as the brand-name product.
“There are appropriate times and ways to compound, and
there are inappropriate ways to compound,” says Lynne White-Shim, MS, DVM, an
assistant director in the American Veterinary Medical Association’s Scientific
Activities Division. “When a veterinarian is deciding how to treat his or her
patient that has a medical condition, the veterinarian needs to follow federal
rules if he or she decides on an extralabel use of a product, and compounding
rules are a component of extralabel drug-use rules.”
The experts say there is a hierarchy to prescribing
medications, especially when it comes to food animals. The rules allow for
greater flexibility when treating non-food animals, says Dr. White-Shim:
* The
first choice should be an FDA-approved veterinary medication indicated for that
species and marketed for that condition;
* The
second choice should be an FDA-approved veterinary medication which might be
indicated for another species;
* The third choice would be an FDA-approved human medication indicated
for that condition; and
*
Fourth, if there are no FDA-approved medications, a compounded drug.
“If a veterinarian is prescribing a compounded product
knowing that there is an equivalent FDA-approved medication on the market, then
that is an FDA violation,” says Farris, the attorney. “If there is an
FDA-approved medication, FDA regulations prohibit veterinarians from
prescribing a compounded equivalent, and prohibit a compounding pharmacy from
producing it.”
Limitations
Generally speaking, compounding pharmacies are
restricted from promoting or advertising unapproved new animal drugs, creating
and marketing compounded preparations that mimic FDA-approved medications, and
manufacturing large quantities of drugs under the guise of compounding or
distributing these preparations wholesale.
They are permitted to advertise in certain instances,
such as when the compounded product serves many patients that do not have
access to an FDA-approved product.
Some compounding pharmacies skirt the law,
veterinarians and pharmaceutical companies contend, and the FDA lacks the
resources to prosecute every violation.
Berk notes that the American Association of Equine
Practitioners and the AVMA, which have issued guidance for veterinarians about
the appropriate use of compounded products in veterinary medicine, encourage
the FDA to become more involved in enforcing compounding regulations.
“Veterinarians are under additional legal exposure
when they use compounded drugs,” Berk says.
The experts provide these tips to limit that exposure:
* Make
sure you have a valid veterinarian-client-patient relationship and provide full
disclosure about the compounded drug, its risks and why it is being prescribed.
* Use
compounded drugs only if an FDA-approved medication (indicated for either
animals or human use) is not available or cannot adequately treat the medical
condition at hand, and the health of the animal is threatened, or if suffering
or death may result from failure to treat.
*
Check whether the pharmacy is certified by an independent body, such as the
Pharmacy Compounding Accreditation Board.
*
Contact the state board of pharmacy to find out the status of the pharmacy
within the state and assure that it is licensed to compound in that state.
“Veterinarians often believe they are providing a cost
savings to the client, but their clients may not understand that the cost of
the legitimate FDA-approved products include long-term testing for efficacy,
safety, consistency and purity. There might also be a lack of understanding of
the legal ramifications the veterinarian faces,” says Farris.
“In addition,” Farris continues, “the owner relies on
the veterinarian to provide the appropriate standard of care. Using untested,
unproven compounded products when there is an FDA-approved medication available
not only violates FDA regulations, but increases the veterinarian’s liability
exposure in circumstances not typically covered by insurance.”
Thursday, May 17, 2012
Texas State Board of Pharmacy's Ability to Impose Discipline for Violations of Other States' Law
An excellent blog post entitled, Texas State Board of Pharmacy's Ability to Impose Discipline for Violations of Other States' Law, posted on on February 3, 2011,and written by Louis Leichter, explains how Texas Board of Pharmacy, pursuant to Texas law, is authorized to discipline pharmacists for violating another state's law pertaining to drugs or the practice of pharmacy. Leichter notes that this grant of jurisdiction is expansive and raises unique regulatory pitfalls for Texas pharmacists whose practice reaches into other states or who hold licenses in multiple jurisdictions. With regard to the law relating to compounding medications, this is another example where a pharmacist needs to not only check federal law and the law of the state where licensed, but the pharmacist also needs to check the law of any other state where business is being conduct. For example, if the pharmacist is licensed in Texas, but delivering or shipping compounded medications to Oklahoma, the pharmacist would need to comply with applicable Texas and Oklahoma state law and any applicable federal laws.
Click here to view the post.
United States General Accounting Office Report on State and Federal Oversight of Drug Compounding by Pharmacies
In 2003, Janet Heirich, who was then the Director of Health Care--Public Health Issues, testified before Congress regarding State and Federal Oversight of Drug Compounding by Pharmacies. Her testimony was based on a very interesting study conducted by the United States General Accounting Office. To review that report click here.
Wednesday, May 16, 2012
Compliance Study on Sterile Compounding Practices Calls for Participants
From the National Association of Boards of Pharmacy website dated May 16, 2012:
Compliance Study on Sterile Compounding Practices Calls for Participants
Topics: Compounding, Patient Safety
Sterile compounding facilities are invited to participate in the 2012 USP 797 Compliance Study, a National Study of Sterile Compounding Practices, co-directed by sterile compounding experts, Eric Kastango, RPh, MBA, FASHP, and Kate Douglass, MS, RN, APN,C, CRNI. The study is now open and will remain open through June 30, 2012. The study, first conducted in 2011, is the largest and most comprehensive study of 797 compliance ever undertaken in the US, as noted in an announcement from CriticalPoint. After this year, the study team plans to repeat the study again one year after the US Pharmacopeial Convention (USP) Expert Committee makes final the newest changes to the chapter, expected in late 2013. It is hoped that the information and insights gained from this study will assist in benchmarking progress and identifying where additional resources and focus are required to continue to improve sterile compounding practice and patient safety. More information and a link to participate in the study are available at www.797study.com (Survey Code B797A). Questions may also be directed to the study team by calling 240/238-4352. The results of the study will be published this fall in Pharmacy Purchasing & Products Magazine.
Monday, May 14, 2012
Drug Compounding for Veterinary Patients
In 2005, the AAPS Journal published an article entitled Drug Compounding for Veterinary Patients
written by Mark G. Papich. Although this article was written several years ago it is still a good resource. The article contains the following topics:
Current Regulations on Compounded Veterinary Drugs
The Need for Compounded Drugs in Veterinary Medicine
Potential Problems Caused by Compounded Formulations
Examples of Potential Problems
The Interspecies Problem
Transdermal Drugs
Current Guidelines for Veterinarians
Future of Veterinary Drug Compounding
Oral Arguments Set in Franck's case for week of October 29, 2012
The 11th Circuit Court of Appeals has set the Franck's case on the oral argument tentative calendar to be held in Atlanta during the week of October 29, 2012. The actual date and time of the oral argument will be announced later. As previously, discussed on this blog, here is an overview of the appellate process:
Jurisdiction of 11th Circuit Court of Appeals The Franck's case is currently pending at the 11th Circuit Court of Appeals. I thought a short discussion of federal appellate procedure might be helpful. The 11th Circuit Court of Appeals is a federal court with appellate jurisdiction over the district courts in the following districts: 1. Middle District of Alabama 2. Northern District of Alabama 3. Southern District of Alabama 4. Middle District of Florida 5. Northern District of Florida 6. Southern District of Florida 7. Middle District of Georgia 8. Northern District of Georgia 9. Southern District of Georgia What the 11th Circuit Can Consider A federal appellate court is generally only allowed to consider the record that was established in the district court. There are some exceptions, but for the most part if the evidence or information was not presented in the district court then the 11th Circuit will not be allowed to consider it on appeal. The same principle generally applies to legal arguments made on appeal. If the argument was not made in the district court, there is a strong chance it will be considered waived or forfeited on appeal. Again there are exceptions. Oral Argument Once briefing is done in Francks, the case will be submitted to a panel of three judges to review the district court decision. Approximately three-fourths of the court's cases are decided on the briefs submitted by the parties, while the remaining cases include oral argument. Oral arguments are held in the Elbert P. Tuttle United States Court of Appeals Building in Atlanta, Georgia and are open to the public. Oral arguments are also held in Florida (Jacksonville and Miami) and Alabama (Montgomery). Most likely in Franck's the judges will set the case for oral argument because the parties have requested oral argument. Each side's attorneys will get 15 minutes to argue the position of the party represented. The amicus curiae who filed briefs in the Franck's case may participate in oral argument only with the court's permission. Timing of Decision After oral argument, the appellate court will issue a decision. There is no time limit on when the decision has to be issued. Some cases can take over a year before an appellate court issues its opinion. The Written Opinion The opinion will consist of a written analysis that reviews the district court's decision. The appellate court can (1) affirm the district court decision; (2) reverse the district court decision; (3) modify the district court decision or (4) remand the case for further the district court to make further factual findings. This decision will be binding only in the states listed above that make up the 11th Circuit Court of Appeals. It will be persuasive authority in all other states, but those federal courts will not be bound by the decision and can reach a totally contrary result if presented with the issue. Only if the issue is decided by the United States Supreme Court will the decision be binding in all federal courts. Options of Losing Party At that point, the losing party can file a (1) petition for rehearing before the three judge panel, (2) file a petition for rehearing en banc before the full 11th Circuit Court of Appeals (3) petition for certiorari to the United States Supreme Court or (4) accept the decision and implement whatever it says. A court of appeals is not required to grant a petition for rehearing before the three judge panel or before the full court. Furthermore, the United States Supreme Court would not be required to grant certiorari. Each of the first three options has different legal standards that must be met. |
JUDGE IN NORTHERN DISTRICT OF TEXAS SETS SCHEDULING ORDER FOR SENTENCING as to Gary D Osborn, Apothecure Inc
SCHEDULING ORDER FOR SENTENCING as to Gary D Osborn, Apothecure Inc:
Presentence Investigation Report due by 7/6/2012.
Objections to Presentence Investigation Report due by 7/20/2012.
Presentence Investigation Addendum due by 7/27/2012.
Objections to Presentence Investigation Addendum due by 8/3/2012.
Sentencing set for 9/21/2012 01:30 PM before Judge Barbara M.G. Lynn.
Motions for Downward Departure due by 9/12/2012.
Sentencing Memoranda and Character Letters due by 9/12/12.
Presentence Investigation Report due by 7/6/2012.
Objections to Presentence Investigation Report due by 7/20/2012.
Presentence Investigation Addendum due by 7/27/2012.
Objections to Presentence Investigation Addendum due by 8/3/2012.
Sentencing set for 9/21/2012 01:30 PM before Judge Barbara M.G. Lynn.
Motions for Downward Departure due by 9/12/2012.
Sentencing Memoranda and Character Letters due by 9/12/12.
Sunday, May 13, 2012
Franck's Compounding Lab: Notice of Recall - Triamcinolone acetonide P.F. 80mg/ml
These recalls relating to Franck's Compounding Lab were issued on March 31, 2012, and May 1, 2012
Recall -- Firm Press Release
FDA posts press releases and other notices of recalls
and market withdrawals from the firms involved as a service to consumers, the
media, and other interested parties. FDA does not endorse either the product or
the company.
Notice of Recall - Triamcinolone acetonide P.F. 80mg/ml
Contact:
Jim Kilbride, RPh
Pharmacist-in-Charge
Franck’s Compounding Lab
1210 SW 33rd Ave. Ocala, FL 34474
352-622-2913
Fax: 352-690-6770
May 2, 2012
Dear Physician,
Franck’s lab recently had a fungal issue with one lot of triamcinolone
acetonide P.F. 80mg/ml and on March 29, 2011 instituted a recall. The recall
involved five physicians and eight prescriptions. The physicians have been
contacted and all prescriptions accounted. As a precaution Franck’s Lab has
recalled one additional lot of triamcinolone acetonide P.F. 80mg/ml. No adverse
events have been reported related to this lot. The recall involved four
physicians and five prescriptions. All offices have been contacted. If you have
any concerns or questions regarding a prescription of triamcinolone acetonide or
product containing triamcinolone acetonide received from Franck’s do not
hesitate to contact us.
Regards,
Jim Kilbride, RPh
Pharmacist-in-Charge
Franck’s Compounding Lab
1210 SW 33rd Ave. Ocala, FL 34474
352-622-2913
Fax: 352-690-6770
Jim Kilbride, RPh
Pharmacist-in-Charge
Franck’s Compounding Lab
1210 SW 33rd Ave. Ocala, FL 34474
352-622-2913
Fax: 352-690-6770
Recall -- Firm Press Release
FDA posts press releases and other notices of recalls
and market withdrawals from the firms involved as a service to consumers, the
media, and other interested parties. FDA does not endorse either the product or
the company.
NOTICE OF RECALL
Contact:
Jim Kilbride, RPh
Pharmacist-in-Charge
Franck’s Compounding Lab
1210 SW 33rd Ave. Ocala, FL 34474
352-622-2913
Fax: 352-690-6770
March 31, 2012
Dear Physician
Franck’s lab recently had a fungal issue with one lot of triamcinolone acetonide P.F. 80mg/ml and instituted a recall. The recall involved five physicians and seven prescriptions. The physicians have been contacted and all prescriptions accounted. If you have any concerns or questions regarding a prescription of triamcinolone acetonide or product containing triamcinolone acetonide received from Franck’s do not hesitate to contact us.
Franck’s lab recently had a fungal issue with one lot of triamcinolone acetonide P.F. 80mg/ml and instituted a recall. The recall involved five physicians and seven prescriptions. The physicians have been contacted and all prescriptions accounted. If you have any concerns or questions regarding a prescription of triamcinolone acetonide or product containing triamcinolone acetonide received from Franck’s do not hesitate to contact us.
Regards,
Jim Kilbride, RPh
Pharmacist-in-Charge
Franck’s Compounding Lab
1210 SW 33rd Ave. Ocala, FL 34474
352-622-2913
Fax: 352-690-6770
Jim Kilbride, RPh
Pharmacist-in-Charge
Franck’s Compounding Lab
1210 SW 33rd Ave. Ocala, FL 34474
352-622-2913
Fax: 352-690-6770
###
Georgetown's Food, Drug, and Cosmetic Law Research Guide
A wonderful resource regarding researching Food, Drug, and Cosmetic Law Research Guide in the United States can be found at Georgetown's Law Library website. Click here to view the list.
FDA's 2012 Enforcement Priorities
At the recent December 2011 Food and Drug Law Institute (FDLI) conference on Enforcement, Litigation and Compliance Conference in Washington, DC, Howard Sklamberg, Deputy Associate Commissioner for Regulatory Affairs, ORA, FDA at U.S. Food and Drug Administration, gave a speech on ORA 2012 Enforcement Priorities. The slides from that presentation can be viewed here. Sklamberg's conclusion included these points:
- Enforcing the laws and regulations is one of the Agency’s highest priorities.
- Effective enforcement ensures that businesses
- remain vigilant about their corporate responsibility to comply with the laws enforced by FDA;
- firms invest in quality systems that prevent harm to the public; and
- those who do comply with the law are not unfairly disadvantaged.
- FDA needs to transform from a domestically-focused safety agency operating in a globalized world to a truly globally-focused agency that is fully prepared for a regulatory environment in which national borders are less relevant to product safety than they have been in the past.
- FDA intends to build international coalitions of regulators who have the capability and technology to rapidly share public health information and protect those they serve.
- Advantages for industry may include: fewer inspections, stream-lined regulation, level playing field between foreign and domestic producers, elimination of the competitive advantage of non-compliance.
- This monumental effort will take a long-term investment in time and resources, but the pay off will be added safety and security for American consumers.
Saturday, May 12, 2012
Capitol Weekly: Compound drugs fuel dispute between docs, insurers, labor
The following article appears in Capitol Weekly regarding compound drugs in California and bill introduced to include a fee schedule for compound drugs in that state:
Compound drugs fuel dispute between docs, insurers, labor
Compound drugs fuel dispute between docs, insurers, labor
By John Howard | 09/08/11 12:00 AM PST
It started in a small way, doctors’ use of specially mixed drugs to help treat workers injured on the job.
But in recent years, the practice has ballooned, driven by a lack of fiscal safeguards on the sale and distribution of so-called compounded drugs for the treatment of injured workers in the state’s workers’ compensation insurance system.
The issue is thorny and contentious, in part because it deals directly with the pocketbook, in part because doctors believe there is a potential here to interfere with their medical decision-making.
The use of compounded drugs – mostly creams and ointments – has risen exponentially. One 2010 study found that sales of the medications and so-called “medical foods” more than quadrupled, from 2.3 percent to 12 percent between 2006 and 2009.
Compounded drugs, mixed and dispensed by doctors and some pharmacies – now entail sales worth at least $100 million annually, experts believe. The mixtures aren’t FDA-approved but are legal.
But a problem has arisen: The medications’ costs aren’t adequately controlled, contend critics of the existing system, as in other programs that entail government reimbursements, such as Medi-Cal, which has a detailed fee schedule. That schedule defines how much medical providers receive for specific services.
Legislation awaiting action in the Senate, AB 378 by Assemblyman Jose Solorio, D-Santa Ana, would pave the way for such a schedule. It blocks doctors from referring patients to any place for medications in which the doctor has a financial interest. It also requires compounded drugs to be billed at the ingredient level – a move that conforms with rules already in place at the state Pharmacy Board.
On Wednesday negotiations between the rival parties were under way to reach a compromise on the legislation by midnight Friday, when the Legislature adjourns for the year. Late Wednesday, however, it failed on a Senate vote. Lawmakers agreed to reconsider the measure, which means it could come up again, however.
The bill has an odd array of supporters – including the California Labor Federation, the American Insurance Association and the Association of California Insurance Companies. Foes are led by the California Medical Association and the California Pharmacists Association, among others.
For them, the problem is that the fee schedule sought by Solorio reflects antiquated dollar amounts and, ultimately, shortchanges those who dispense the medications.
“It (the bill) includes pharmacy compounding but for the methodology, they are relying on a medical fee schedule that hasn’t been updated for 30 years. We propose ingredient costs, plus appropriate (reimbursement) for time and expertise,” said Jon Roth, CEO of the 5,000-member California Pharmacists Association.
Pharmacies are increasingly getting into compounded medications, he added. “It’s getting back to the roots of pharmacies, with customized medications specific to the patient’s illness.”
The ingredients are provided to the doctors by makers or wholesalers – sometimes fee of charge – who mix and dispense the medications, then receive reimbursement through the workers' compensation system. In some cases, a third-party bills the system on behalf of the physician. Some pharmacies, called compounding pharmacies, also mix and dispense the medications.
Physicians note that the compounded drugs are specifically tailored to the needs of individual patients, especially in cases of injured employees because “they (compounded drugs) focus on pain management and musculoskeletal injuries, which are common among injured workers,” according to an Assembly analysis.
The State Compensation Insurance Fund, a quasi-governmental entity that provides workers' comp coverage to employers, has told doctors to halt prescribing compound drugs without prior permission of an insurance adjuster or under an order of a workers' compensation judge.
The 35,000-member California Medical Association said this week that SCIF’s move interfered with a doctor’s decision making, even to the point of barring medications at all “regardless of medical necessity.”
The CMA “believes that these new provisions are an attempt by SCIF to exert control over physicians' practice of medicine and clinical judgment,” the association noted in a written statement, requiring doctors “to treat injured workers differently than other patients and violate state law, which allows for prescribing, dispensing, furnishing or administering controlled substances …”
The CMA also said SCIF’s rule could force physicians to be “kicked out of the MPN (medical provider network)” from which doctors are chosen to treat workers in the workers' compensation insurance system.
But Solorio is skeptical about the need for compounding.
“Drug compounding - a legal but rarely necessary practice - has exploded as a physician profit-center in workers' comp," he said in a statement provided through his Capitol staff. "The State Compensation Insurance Fund reports that what was "rarely" billed prior to 2007 rapidly escalated to over $58 million in billings in a 16-month period. That practice must be stopped," he added.
The bill’s principal backers agreed.
“Drug compounders have been able to circumvent the existing pharmacy fee schedule and as a result, pharmacy costs are increasing. One company reported their costs for compound drugs now makes up 44 percent of their pharmacy costs - up from 9.6 percent the previous year,” said a message to lawmakers from the insurers and the California Labor Federation.
But in recent years, the practice has ballooned, driven by a lack of fiscal safeguards on the sale and distribution of so-called compounded drugs for the treatment of injured workers in the state’s workers’ compensation insurance system.
The issue is thorny and contentious, in part because it deals directly with the pocketbook, in part because doctors believe there is a potential here to interfere with their medical decision-making.
The use of compounded drugs – mostly creams and ointments – has risen exponentially. One 2010 study found that sales of the medications and so-called “medical foods” more than quadrupled, from 2.3 percent to 12 percent between 2006 and 2009.
Compounded drugs, mixed and dispensed by doctors and some pharmacies – now entail sales worth at least $100 million annually, experts believe. The mixtures aren’t FDA-approved but are legal.
But a problem has arisen: The medications’ costs aren’t adequately controlled, contend critics of the existing system, as in other programs that entail government reimbursements, such as Medi-Cal, which has a detailed fee schedule. That schedule defines how much medical providers receive for specific services.
Legislation awaiting action in the Senate, AB 378 by Assemblyman Jose Solorio, D-Santa Ana, would pave the way for such a schedule. It blocks doctors from referring patients to any place for medications in which the doctor has a financial interest. It also requires compounded drugs to be billed at the ingredient level – a move that conforms with rules already in place at the state Pharmacy Board.
On Wednesday negotiations between the rival parties were under way to reach a compromise on the legislation by midnight Friday, when the Legislature adjourns for the year. Late Wednesday, however, it failed on a Senate vote. Lawmakers agreed to reconsider the measure, which means it could come up again, however.
The bill has an odd array of supporters – including the California Labor Federation, the American Insurance Association and the Association of California Insurance Companies. Foes are led by the California Medical Association and the California Pharmacists Association, among others.
For them, the problem is that the fee schedule sought by Solorio reflects antiquated dollar amounts and, ultimately, shortchanges those who dispense the medications.
“It (the bill) includes pharmacy compounding but for the methodology, they are relying on a medical fee schedule that hasn’t been updated for 30 years. We propose ingredient costs, plus appropriate (reimbursement) for time and expertise,” said Jon Roth, CEO of the 5,000-member California Pharmacists Association.
Pharmacies are increasingly getting into compounded medications, he added. “It’s getting back to the roots of pharmacies, with customized medications specific to the patient’s illness.”
The ingredients are provided to the doctors by makers or wholesalers – sometimes fee of charge – who mix and dispense the medications, then receive reimbursement through the workers' compensation system. In some cases, a third-party bills the system on behalf of the physician. Some pharmacies, called compounding pharmacies, also mix and dispense the medications.
Physicians note that the compounded drugs are specifically tailored to the needs of individual patients, especially in cases of injured employees because “they (compounded drugs) focus on pain management and musculoskeletal injuries, which are common among injured workers,” according to an Assembly analysis.
The State Compensation Insurance Fund, a quasi-governmental entity that provides workers' comp coverage to employers, has told doctors to halt prescribing compound drugs without prior permission of an insurance adjuster or under an order of a workers' compensation judge.
The 35,000-member California Medical Association said this week that SCIF’s move interfered with a doctor’s decision making, even to the point of barring medications at all “regardless of medical necessity.”
The CMA “believes that these new provisions are an attempt by SCIF to exert control over physicians' practice of medicine and clinical judgment,” the association noted in a written statement, requiring doctors “to treat injured workers differently than other patients and violate state law, which allows for prescribing, dispensing, furnishing or administering controlled substances …”
The CMA also said SCIF’s rule could force physicians to be “kicked out of the MPN (medical provider network)” from which doctors are chosen to treat workers in the workers' compensation insurance system.
But Solorio is skeptical about the need for compounding.
“Drug compounding - a legal but rarely necessary practice - has exploded as a physician profit-center in workers' comp," he said in a statement provided through his Capitol staff. "The State Compensation Insurance Fund reports that what was "rarely" billed prior to 2007 rapidly escalated to over $58 million in billings in a 16-month period. That practice must be stopped," he added.
The bill’s principal backers agreed.
“Drug compounders have been able to circumvent the existing pharmacy fee schedule and as a result, pharmacy costs are increasing. One company reported their costs for compound drugs now makes up 44 percent of their pharmacy costs - up from 9.6 percent the previous year,” said a message to lawmakers from the insurers and the California Labor Federation.
Friday, May 11, 2012
Consulting Applicable Law: Federal and State
Both the state and the federal laws need to be consulted when dealing with compound medications. An example of this is when one is dealing with "office use" or "office administration" of medications--both medications for humans and medications for animals. In general, "office use" or "office administration" of medications refers to "limited" or "reasonable" quantities and for administration in the office, institution or hospital. This does not mean a doctor or veterinarian can dispense the medication to the patient. To determine specifically if one is complying with applicable law, first consult your State Board of Pharmacy rules and regulations regarding "office use."
Second, one should consult the state rules and regulations of any state where medications will be shipped or delivered to, if the medication, is not being shipped or delivered to one's home state. For example, Oklahoma's rules allow the "office use" of compounded medications except for controlled substances as written in their state rules, which is the same as the United States Drug Enforcement Administration (DEA), patient-specific, controlled substance prescription requirement, which is discussed below. Missouri's rules, on the other hand, strictly forbid the "office use" of compounded medications. Whereas, Texas' rules allow the "office use" of compounded medications, but requires a specific contract between pharmacy and practitioner.
Second, one should consult the state rules and regulations of any state where medications will be shipped or delivered to, if the medication, is not being shipped or delivered to one's home state. For example, Oklahoma's rules allow the "office use" of compounded medications except for controlled substances as written in their state rules, which is the same as the United States Drug Enforcement Administration (DEA), patient-specific, controlled substance prescription requirement, which is discussed below. Missouri's rules, on the other hand, strictly forbid the "office use" of compounded medications. Whereas, Texas' rules allow the "office use" of compounded medications, but requires a specific contract between pharmacy and practitioner.
Third, you must consult any applicable federal law. For example, 21 CFR § 1306.04 relates to the purpose of issue of prescription. That section provides:
Section 1306.04 Purpose of issue of prescription.
(a) A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.
(b) A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients.
(c) A prescription may not be issued for “detoxification treatment” or “maintenance treatment,” unless the prescription is for a Schedule III, IV, or V narcotic drug approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment and the practitioner is in compliance with requirements in §1301.28 of this chapter.
[36 FR 7799, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 39 FR 37986, Oct. 25, 1974; 70 FR 36343, June 23, 2005]
The DEA does not recognize compounded, controlled substance medications ordered for "office use" or "office administration." Thus, controlled substance cannot be shipped to a doctor's office, but must be patient-specific and delivered directly to patients.
What law applies to compounded medications is a tricky and developing area of the law. It is essential that all involved in the chain dealing with compounded medications consult both state and federal law to ensure compliance with all applicable laws.
Thursday, May 10, 2012
Website with Links to All the State Laws Relating to Compounding
The Compounding Pharmacy Compliance website contains links to all the state laws relating to compounding. Click here to view the links. This website also contains other useful information. For example, this website points out that Texas and South Carolina allow the "office use" of compounded medications, but requires a specific contract between pharmacy and practitioner. The specific requirements that must be found in these contracts can be found in each state's rules.
Wednesday, May 9, 2012
Oklahoma State Board of Pharmacy Expects Compliance with USP 795 and 797
Oklahoma's State Board of Pharmacy April 2012 Newsletter has the following notice regarding compliance with 795 and 797:
12.07. USP 795/797: Compounding pharmacies are now expected to be in full compliance with United States Pharmacopeia (USP) Guidelines 795 (nonsterile products) and 797 (sterile products). These rules may be found in Section OAC 535:15-10 of the Oklahoma Pharmacy Lawbook.
Compounding pharmacists should be familiar with these regulations and act accordingly. Hazardous chemicals (which may include hormones) must be prepared in a Class 1 biological safety cabinet.
Click here to view entire newsletter.
State Pharmacy, Medical and Veterinary Boards Need to Remain Independent and Objective and Not Promote Individual Agendas
A very good article entitled, When is A State Agency Not a State Agency? written by Dale J. Atkinson, JD, appears in the May 2012 National Association of Board of Pharmacy Newsletter. Atkinson points out that state boards, such as state pharmacy, state medical and state veterinary boards need to not cloud the mission of the board by promoting individual agendas. Members of these board need to remain independent and objective for a number of reason. This is especially true in the area of compounding. Here is a portion of the article:
The common law and statutory immunity principles that protect the regulatory boards from liability are essential to the independent and objective operations and decision-making of the boards of pharmacy. Board members must preserve the integrity of the regulatory process by ensuring that decisions made are based upon overall public protection considerations and reflect the collective wisdom of the board as a whole. Individual agendas or professional promotion perspectives cloud the mission of the board and can implicate significant personal and/or pharmacy board scrutiny, which may eventually lead to legal analyses of how and when immunity principles can be propounded.
Self-regulation, that is governmental regulatory boards being comprised primarily of licensees, is always ripe for allegations of professionals protecting professionals. Such is currently under consideration in the litigation involving the North Carolina State Board of Dental Examiners which was the subject of a recent NABP Newsletter article (“FTC: Facinorous Teeth Case,” August 2011 NABP Newsletter). Indeed, the immunity principles are front and center to that ongoing case. Further, challenges to the immunity protections of the Alabama Board of Dental Examiners are ongoing and in need of scrutiny.
The full article is available in the May 2012 NABP Newsletter, and reviews a relevant case involving the Alabama Board of Dental Examiners and a former Board employee.
State Boards of Pharmacy Reported 4324 disciplinary actions in 2011
The April 2012 Newsletter of the National Association of Board of Pharmacy reports that state boards of pharmacy reported 4,324 disciplinary actions to the NABP Clearinghouse in 2011. The percentages of the disciplinary actions report are as follows:
Probation of License (19.7%)
Administrative or Publicly Available Fine/Monetary Penalty (14.8%)
Revocation of License (12.5%)
Suspension of License (11%)
Voluntary Surrender of License (10.7%)
Miscellaneous* (10%)
License Restored or Reinstated,
Complete and Conditional (9.2%)
Reprimand or Censure (9%)
Summary or Emergency Suspension of License (3%)
To view the entire article, click here.
More Information on Ban in India on Cisapride, Phenylpropanolamine and Nimesulide
The ban in India on cisapride, phenylpropanolamine and nimesulide started in January 2011 and was finalized in October 2011. The ban on cisapride was for HUMAN use and does not mention animals. Here are the links to the official Indian documents:
To view the list of drugs banned by India click here and scroll down to find cisapride at number 63.
To view the National communication of ban (effective date of ban) click here.
Those in the veterinary world are still very hopeful that the Indian government will consider allowing production for animal use.
Monday, May 7, 2012
Resources relating to Veterinary Compounding
The American Association of Equine Practitioners has links to a number of resources relating to veterinary compounding. Click here to view any of the following articles.
Illegal Drug Compounding | |
by Dr. Jim Morehead
|
by Dr. Jim Morehead
|
By Dr. Kenton Morgan
| |
Scott D. Stanley, Ph.D., Professor
University of California, Davis School of Veterinary Medicine |
Developed by the AAEP Biological and Therapeutic Agents Committee
|
Factors FDA considers in Deciding Whether to Take Enforcement Action
Importation of Active Pharmaceutical Ingredients (APIs) Requirements CPG 460.200 Pharmacy Compounding Compliance Policy Guides Manual (Tab M), in part provides:
Generally, FDA will continue to defer to state authorities regarding less significant violations of
the Act related to pharmacy compounding of human drugs. FDA anticipates that, in such cases,
cooperative efforts between the states and the Agency will result in coordinated investigations,
referrals, and follow-up actions by the states.
However, when the scope and nature of a pharmacy's activities raise the kinds of concerns
normally associated with a drug manufacturer and result in significant violations of the new
drug, adulteration, or misbranding provisions of the Act, FDA has determined that it should
seriously consider enforcement action. In determining whether to initiate such an action, the
Agency will consider whether the pharmacy engages in any of the following acts:
1. Compounding of drugs in anticipation of receiving prescriptions, except in very limited
quantities in relation to the amounts of drugs compounded after receiving valid
prescriptions.
2. Compounding drugs that were withdrawn or removed from the market for safety reasons.
Appendix A provides a list of such drugs that will be updated in the future, as appropriate.
3. Compounding finished drugs from bulk active ingredients that are not components of FDA
approved drugs without an FDA sanctioned investigational new drug application (IND) in
accordance with 21 U.S.C. § 355(i) and 21 CFR 312.
4. Receiving, storing, or using drug substances without first obtaining written assurance from
the supplier that each lot of the drug substance has been made in an FDA-registered facility.
5. Receiving, storing, or using drug components not guaranteed or otherwise determined to
meet official compendia requirements.
6. Using commercial scale manufacturing or testing equipment for compounding drug product
7. Compounding drugs for third parties who resell to individual patients or offering
compounded drug products at wholesale to other state licensed persons or commercial
entities for resale.
8. Compounding drug products that are commercially available in the marketplace or that are
essentially copies of commercially available FDA-approved drug products. In certain
circumstances, it may be appropriate for a pharmacist to compound a small quantity of a
drug that is only slightly different than an FDA-approved drug that is commercially
available. In these circumstances, FDA will consider whether there is documentation of the
medical need for the particular variation of the compound for the particular patient.
9. Failing to operate in conformance with applicable state law regulating the practice of
pharmacy.
The foregoing list of factors is not intended to be exhaustive. Other factors may be appropriate
for consideration in a particular case.
Generally, FDA will continue to defer to state authorities regarding less significant violations of
the Act related to pharmacy compounding of human drugs. FDA anticipates that, in such cases,
cooperative efforts between the states and the Agency will result in coordinated investigations,
referrals, and follow-up actions by the states.
However, when the scope and nature of a pharmacy's activities raise the kinds of concerns
normally associated with a drug manufacturer and result in significant violations of the new
drug, adulteration, or misbranding provisions of the Act, FDA has determined that it should
seriously consider enforcement action. In determining whether to initiate such an action, the
Agency will consider whether the pharmacy engages in any of the following acts:
1. Compounding of drugs in anticipation of receiving prescriptions, except in very limited
quantities in relation to the amounts of drugs compounded after receiving valid
prescriptions.
2. Compounding drugs that were withdrawn or removed from the market for safety reasons.
Appendix A provides a list of such drugs that will be updated in the future, as appropriate.
3. Compounding finished drugs from bulk active ingredients that are not components of FDA
approved drugs without an FDA sanctioned investigational new drug application (IND) in
accordance with 21 U.S.C. § 355(i) and 21 CFR 312.
4. Receiving, storing, or using drug substances without first obtaining written assurance from
the supplier that each lot of the drug substance has been made in an FDA-registered facility.
5. Receiving, storing, or using drug components not guaranteed or otherwise determined to
meet official compendia requirements.
6. Using commercial scale manufacturing or testing equipment for compounding drug product
7. Compounding drugs for third parties who resell to individual patients or offering
compounded drug products at wholesale to other state licensed persons or commercial
entities for resale.
8. Compounding drug products that are commercially available in the marketplace or that are
essentially copies of commercially available FDA-approved drug products. In certain
circumstances, it may be appropriate for a pharmacist to compound a small quantity of a
drug that is only slightly different than an FDA-approved drug that is commercially
available. In these circumstances, FDA will consider whether there is documentation of the
medical need for the particular variation of the compound for the particular patient.
9. Failing to operate in conformance with applicable state law regulating the practice of
pharmacy.
The foregoing list of factors is not intended to be exhaustive. Other factors may be appropriate
for consideration in a particular case.
Two Key Things Regarding Compounding: Follow the Applicable State Law and Price Should Not Be A Factor
An article written by Scott Karolchyk, MS, RPh, FIACP, entitled Pharmaceticual Compounding, The Right and Responsibility fo Pharmacists to Compound , appearing in the American Journal of Mesotherapy can be read by clicking here. Karolchyk makes two very good points:
1. follow the applicable state law relating to pharmacy and compounding and
2. price is not a factor; and advertisements or marketing promoting the price of compounded preparations should not be used. If price is advertised, the FDA may view that the company is a manufacturer or wholesaler.
Here is Karolchyk's entire list of factors to remember:
1. follow the applicable state law relating to pharmacy and compounding and
2. price is not a factor; and advertisements or marketing promoting the price of compounded preparations should not be used. If price is advertised, the FDA may view that the company is a manufacturer or wholesaler.
Here is Karolchyk's entire list of factors to remember:
The Responsibilities of Pharmacists to the Profession Patients, and Colleague
1. Operate in conformance with applicable state law regulating the practice of pharmacy
2. Ensure that your professional conduct is above reproach.
3. Practice the art and skill of compounding pharmacy to the best of your ability.
4. Know the limits of your expertise and refer to colleague on issues beyond your knowledge and skill.
5. Continue self-education to improve your standard of compounding practice.
6. When possible, accept responsibility to advance the profession of pharmacy and the practice of compounding by participating in properly developed programs,research projects, seminars, teaching opportunities, lectures, and publications.
7. When possible, accept responsibility to advance the profession of pharmacy and practice of compounding by taking leadership positions with the state association, licensing authority, college of pharmacy, national pharmacy organization, or other organizations that have as their objective the betterment of the profession of pharmacy.
8. Willingly accept responsibility to advance the professionof pharmacy and the practice of compounding by representing to lawmakers at the state and national level the policies and agendas that have as their objective the betterment of the profession of pharmacy.
9. Ensure that marketing practices, fee structures, and overall promotion of your practice are implemented in the best interest of the profession and the treatment of patients.
10. Share ideas and information with colleagues and assist them in their professional development.
11. Give credit to the contributions of your colleagues.
12. Be responsible when placing an appropriate value on your services, and consider the time, skill, experience, and any special circumstances involved in the performance of that service when determining any fee.
13. Do not deny services on the basis of race, religion, gender, disability, age, or national origin.
14. Do not dispense medications to a third entity for resale.
15. Uphold the triad relationship of patient, physician, and pharmacist as the basis for pharmacy practice.
16. Know the details of and adhere to the National Association of Boards of Pharmacy Good Compounding Practices Applicable to State-Licensed Pharmacies or other international standards.
17. Do not engage in marketing or promotional practices that:
a. Utilize manufacturers’ names or the names of patented products
b. Create misinformation with claims of therapeutic equivalence
c. Create misinformation by perception that compounded products are generic products
d. Base such promotion and advertising solely on price
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