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Tuesday, April 30, 2013

Statement on Veterinary Compounding from the Veterinary Council in New Zealand

Statement on Compounding Veterinary Medicines
This statement should be read in conjunction with:
• Paragraph 6 of the Veterinary Medicines section of the VCNZ Code of
Professional Conduct and related explanatory notes
• MAF Guidance on Developing a Documented System to meet conditions of
exemption from registration for Compounded Veterinary Preparations under the
ACVM (Exemption) Regulations 2011
Definitions
Compounding means to combine ingredients (for example, generic chemicals or
biological compounds or trade name products) to prepare a medication to be
dispensed to a person to treat an animal. To prepare means not only the process of
combining ingredients in an appropriate manner for the intended purpose but also
placing the medication into appropriate packaging with appropriate labelling to allow
it to be dispensed to and used by a person other than the veterinarian who
compounded it.
Practices that are also included but do not strictly fit the above definition of
compounding are:
• decanting and breaking down trade name products into smaller quantities when
there is no change in the product itself
• reconstituting trade name products, and
• preparing medications to be used immediately by the veterinarian who prepares
the medication.

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What The Proposed Federal Legislation Has to Say About Compounding from Bulk- Vets What Do You Have to Say? You Need to Be Voicing Your Opinions on How This Will Effect You!


Bulk Ingredient Qualifications and Restriction on Wholesaling

The bulk requirements in current section 503A are preserved, with one modification.  Current law requires that any drug compounded from bulk must use bulk active pharmaceutical ingredient that 1) either complies with an applicable United States Pharmacopoeia (USP) or National Formulary (NF) monograph, is part of an FDA-approved drug, or appears on a list established by the Secretary; 2) is manufactured in a registered establishment; and 3) is accompanied by a valid certificate of analysis.  The revised section 503A would permit the Secretary to identify a drug that only has an applicable USP or NF monograph as not suitable for compounding following the publication of the reasoning and consideration of comments submitted to a docket open for at least 30 days. Inactive ingredients also must comply with USP or NF.

If a drug is being compounded for a minor animal species, the same requirements on bulk chemicals apply. However, if a drug is compounded for a non-food major species or food-producing animal, compounding from bulk can only be performed if FDA has listed that bulk ingredient. The major species are cattle, horses, swine, chickens, turkeys, dogs, and cats. Minor animal species are all other species.

Compounded drugs may only be sold by the entity that compounded that product, and all must be labeled “not for resale”. It is a prohibited act to resell a product labeled “not for resale”. 

quoted from the Senate's section by section paper.

Do vets have a problem with this proposed new federal legislation?  If so, you need to get your comments submitted by the May 3, 2013 deadline.

ASHP Statement on HELP Committee Proposed Pharmaceutical Compounding Bill April 30th, 2013 John Buck

The American Society of Health-System Pharmacists (ASHP) is encouraged by the provisions included in draft legislation released by the Senate Committee on Health, Education, Labor, and Pensions (HELP) to address regulatory gaps in the oversight of compounding outsourcers.

“Based on a preliminary assessment, ASHP is pleased with the direction the Senate is heading on this very important legislation that includes key provisions we have advocated for over the past six months,” said ASHP CEO Paul W. Abramowitz, PharmD, FASHP. “We are particularly pleased that the committee recognizes the role of the states in overseeing traditional compounding, including that which occurs in hospitals and health systems, while creating a new definition of a “compounding manufacturer” that would be overseen by the Food and Drug Administration (FDA).”
The Society has been actively engaged with HELP Committee staff as they have developed legislative language and has sought to distinguish patient-care driven hospital and health-system compounding from commercial compounding provided by compounding outsourcers.
The draft legislation establishes a boundary between traditional pharmacy compounding and defines a new entity, “compounding manufacturer,” which compounds preparations without or in advance of a prescription and engages in interstate commerce. It also preserves the states’ primary role in regulating traditional pharmacies.
ASHP will thoroughly review the discussion draft and submit comments to the Committee by its May 3 deadline.
Source: ASHP

Question of the Day: 4/30/2013 Doesn't Congress Needs to Listen to the Experts in the Field--the Ones Who Deal with the Real World of Compounding?

In reading articles recently posted, it is apparent that there is still much misunderstanding about compounding, compounding pharmacies and the state of the law.  If as some commentators say, "the FDA dropped the ball"  then why is there a need for new federal legislation giving them authority over some compounders if in fact they had authority over all compounders or at least the group recently inspected by them?  If the FDA did not drop the ball  and thus did not have authority to regulate, then isn't it true the states dropped the ball and that there may be a need for additonal federal legislaton of some kind?

Doesn't it make sense for Congress to get more input from the people who actually deal with compounding everyday?  Why not call leading pharmcist in compounding and knowledgeable marketing directors that deal with the realities of compounding to testify before them and get their input in how the federal legislation should be drafted?

Health Canada Reviews Compounding Regulations Following Drug Scare
After reports of more than 1,000 patients receiving diluted chemotherapy treatments, Health Canada has implemented an interim solution to cover gray areas in the oversight of small compounding facilities, allowing admixing to continue under strict direction.

International Regulatory Compliance Blog--Compounding Laboratories & Pharmacies – How Safe Are Your Products?


To read this blog 

click here


Will Senate fix compounding pharmacy oversight this time?


The first time most people heard of a “compounding pharmacy” was last fall, when people started dying after getting routine shots produced by one such operation in the Boston area. By early this month, the death toll stood at 53, or 50 more than the marathon bombings.

Among the dead was Douglas Wingate, 47, a Virginia account executive whose only complaint was a pinched nerve in his shoulder. He got a steroid shot and became a victim of a meningitis outbreak tied to tainted injections made by the New England Compounding Center.

More than 700 people in 20 states have been sickened, and many are still suffering.

In the aftermath of this public health disaster, Republicans and Democrats in Congress are debating two questions: Has the Food and Drug Administration failed to use its existing authority to oversee compounders such as NECC? Or does the FDA need broader powers?

The answers are yes, and yes. The FDA repeatedly dropped the ball. And the agency’s authority does need to be clarified and expanded.

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BREAKING NEWS: TN governor signs bill easing compounding--No Requirement Anymore for Patient-Specific Prescription


Gov. Bill Haslam has quietly signed into law a bill that eliminates a Tennessee requirement that pharmacists have a patient-specific prescription before dispensing a specially compounded drug.
The measure, which was backed by the Tennessee Pharmacists Association and sponsored by two legislators who are licensed pharmacists, comes in the wake of a nationwide fungal meningitis outbreak blamed on a Massachusetts drug compounding firm.
Alexia Poe, spokeswoman for the governor, said state Health Department officials worked with legislators to put in safeguards to ensure patient safety.
Those provisions include a requirement that pharmacists doing compounding filequarterly reports with the state on the volume of compounded drugs they are producing. That reporting requirement, however, does not apply to hospital pharmacies.
continue to read here

How a Shadow Drug Industry Tries to Avoid Regulation

How a Shadow Drug Industry Tries to Avoid Regulation

Rules to Be Considered for Adoption at the Texas Board of Pharmacy Meeting on May 7, 2013

Board Meeting Agenda
Tuesday, May 7, 2013, at 9:00 a.m.

The Board business meeting will begin Tuesday, May 7, 2013, at 9:00 a.m.. The  meeting will be held at the William P. Hobby Building, 333 Guadalupe, Tower 2, Room 225, Austin, Texas. Click here to view the agenda and supporting materials.

Rules to be Considered for Adoption
Amendments to the following rules were proposed by the Board and published in the March 8, 2013, issue of the Texas Register and will be consider for adoption at the May 7, 2013, Board business meeting.

Amendments to §281.61 concerning Definition of Discipline Authorized
Amendments to §291.33 concerning Operational Standards
Amendments to §291.34 concerning Records
Amendments to §297.8 concerning Continuing Education Requirements for Pharmacy Technicians 


Source Texas Board of Pharmacy

Communication 101: Encouraging Communication between the FDA and the States is A Start, But the States Need a Purpose and a Plan

By Sue Tuck Richmond
April 30, 2013

Communication in any relationship is essential whether that be a relationship with your spouse, your kids or your boss.  Without good communication, the right hand often doesn't know what the left hand is doing.  Things fall through the cracks.  People speculate and are left to guess and wonder.  This is not a good situation in a personal relationship or in a business relationship.

The proposed federal legislation regarding compounding contemplates that the FDA will encourage direct communication between the states regarding traditional compounders.  It also requires the FDA to communicate with states.  When the  FDA receives a complaint report from a state regulatory agency about a specific traditional pharmacy or pharmacy product, the FDA must relay that information to the state pharmacy board where such facility is licensed within 15 days.

Encouraging states to communicate is a great start but without a purpose and a plan, more communication between the states and states to the FDA will not improve.  In researching a recent complaint, I learned that one state--the state where the compounding pharmacy was a resident-had failed to re-inspect the pharmacy after finding major violations and it never referred the complaint to the FDA.  Another state, the non-resident state of the compounder, received a similar complaint against the same compounding pharmacy.  This state decided the compounder was possibly manufacturing and that the case should be referred to the FDA.  The state inspector sent a letter to and FDA employee in  the local FDA office and indicated in the letter, that she did not know if this was the proper person to refer such complaints to.  This state never communicated with the state where the compounding pharmacy resided.   When I inquired, almost a year later, whether the state inspector in the non-resident states had ever heard from the FDA, the response was no.  The state inspector had done no followup.  To this day it is not clear if this case was ever received by the right person at the FDA.  The compounder is still in business ands till doing the same conduct that was complained about.  What is the remedy for failure to communicate with the proper state or with the FDA?  What is a person who files a complaint to do?  A person should not have to file more than one complaint to receive proper action. A person can only inquire about your complaint so many times.  There was clearly a failure to communicate in this case.

First, the purpose of communication here was clear.  The purpose was to communicate to the proper state and the FDA the complaint to determine if laws were being violating.  Next, there needed to be a plan.  A plan that ensured the proper people were notified of the complaint and the action taken.  In this case, the resident state failed to do a re-inspection and document the file. Second, the non-resident state should have communicate the complaint it received to the resident state and coordinated with that state on referring the complaint to the FDA.  The state inspector from the non-resident state should have picked up the phone and found out the proper place to submit the complaint or at the very least followup with the person she submitted the complaint to and made sure the complaint was forwarded to the proper person at the FDA.  The person at the FDA who received the letter and complaint should have sent a letter back to the state inspector indicating it had received the complaint, that it was or was not the proper place to send such complaints, and if it was not the proper place let the state inspector know where she should send them in the future and what in fact he was doing with the complaint he received.  There appears to have been a complete breakdown in the communication in this case, leaving everyone wondering what, if anything, is being done, with the complaint.  In the future, all parties involved need to have a purpose and a plan in communicating regarding these types of complaint.  Without such a purpose and a plan, there is more likelihood nothing will improve with regard to communication between states and between states and the FDA.

Ten Reasons That the Proposed Compounding Federal Legislation Is Not A Good Idea To Pass In Its Current Form

Sue Tuck Richmond
April 30, 2013

While there are good things about the proposed federal compounding legislation, there are also somethings that make this not the best possible legislation that Congress can pass. Here are ten reasons that the proposed compounding federal legislation is not a good idea to pass in its current form:

1.  Congress appears to be rushing to pass Federal legislation without taking the time to allow all affected parties time to analyze this legislation.  While Congress is asking for comments, they are not allowing much time to submit those comments.  Comments are due May 3, 2013.

2.  There are currently state rules and regulations covering some of the same areas.  These state rules and regulations need to be enforced.  Adding more piecemeal regulations when the current ones are not enforced makes little sense.

3.  The FDA already has jurisdiction over manufacturers.  If a compounding pharmacy is engaged in manufacturing the FDA should already be enforcing its laws.  A new category muddies the water, creates more gray area, and leaves open more areas for litigation.

4.  This proposed legislation contains a number of loopholes.  The bad compounders will continue to find ways around the legislation and use the loopholes to their advantages.

5.  The labeling requirements should not  only require  the name, address, and phone number of the applicable compounding manufacturer, but should also require the name of the pharmacist responsible for preparing the compound.

6.  Exempting hospitals pharmacies who ship interstate within a hospital system from the definition of compounding manufacturer or to excuse them from registration with the FDA will not save lives or ensure public safety.  People receiving these compounds deserve the same protections as everyone else.

7.   Charging a $15,000.00 fee for inspections may cause some good compounders to stop compounding much needed drugs. This is a huge amount to be charged for inspections. In addition the compounder must pay 100 percent of the cost of reinspection.

8.   Only covering preparations prepared without a prescription or in advance of prescription does not ensure public safety.  Compounds prepared with a prescription can also be deadly.  Just because the number of deaths may not be as great as in NECC this does not mean we should not do everything we can to prevent all deaths from bad compounds.

9.    This legislation will require the larger compounders who prepare prescriptions in advance of prescription or without a prescription to be monitored by the FDA but in no way ensures a way for the FDA to monitor, inspect or keep track of the "bad compounders" who do not fit the proposed definition.

10.  The legislation creates a number of areas such as who is a compounding manufacturer that could be highly litigated and take years to be settled by courts. The "bad compounders" who probably meet these definitions will have the resources and money to tie these issues up for years in court, which in effect does not truly advance the ball as far as public safety.

As a side note, Congress is spending too much time trying to place blame on someone when in truth the blame is shared by a number of people--the FDA, the states, bad compounders, organizations and lobbyists, doctors and vets not demanding the highest quality of compounds, and the public for not being educated and knowledgeable and demanding more from doctors, vets, pharmacists, the FDA and states.  Congress needs to be careful to not adopt legislation that actually punishes the the good compounders who are are making every effort to play by the rules.

Monday, April 29, 2013

Question of the Day: 4/29/2013 Why Do More States Not Imposed a Tax on Prescriptions In Order to Collect More Revenue to Use to Hire More Inspectors and Conduct More Pharmacy Inspections?


New FDA Deputy Commissioner Announced By Louise Zornoza, RegLink

29 April 2013
The Secretary of  the US Department of Health and Human Services (DHHS), Kathleen Sebelius, has placed her Chief of Staff, Sally Howard, in FDA’s Office of the Commissioner as the new Deputy [Read More...

GOP lawmakers fault FDA for fatal drug compounding incident ■ A House panel says the agency didn’t do enough to prevent a meningitis outbreak linked to compounded medications. The FDA says it needs more regulatory authority. By Jennifer Lubell amednews staff — Posted April 29, 2013


 An investigation by congressional Republicans suggesting that the Food and Drug Administration missed opportunities to prevent a deadly meningitis outbreak cast a new spotlight on the pharmacy compounding industry and how closely it should be regulated. The industry’s trade group said it was willing to work with the FDA to strengthen state regulations on compounding, but some health care professionals believe these facilities need federal oversight.
Pharmacy compounding refers to a process under which licensed pharmacists work with ingredients to create a tailor-made drug for an individual patient. According to the FDA, this practice, “if done properly, can serve an important public health need if a patient cannot be treated with an FDA-approved medication.”
But something went wrong in 2012 when contamination of an injectible steroid at the New England Compounding Center in Framingham, Mass., resulted in a fungal meningitis outbreak that sickened more than 700 people across the nation, killing 53. The Centers for Disease Control and Prevention had reported the presence of Exserohilum rostratum in sealed, 80 mg/mL vials of preservative-free methylprednisolone acetate produced by NECC, which suspended production soon after the outbreak.
At its Interim Meeting in November 2012, the American Medical Association House of Delegates responded to the events by approving policy for organized medicine to monitor the investigations of these pharmacies and advocate for new regulations that would ensure patient safety.
Republican lawmakers also decided that the event warranted further investigation. On April 16, the majority staff of the House Energy and Commerce Committee released a report concluding that the agency didn’t take appropriate actions against NECC and its sister company, Ameridose, after an initial warning letter in 2006, despite numerous complaints from health care professionals, patients and others that the facilities were engaging in unsafe practices.
Inspections and related enforcement measures had been considered during the past six years, but “they were repeatedly delayed and ultimately canceled,” the report stated. The findings also said the FDA failed to alert the state of Massachusetts routinely about safety issues related to NECC and Ameridose products.

More scrutiny sought

The Energy and Commerce oversight and investigations panel sought further answers from FDA Commissioner Margaret Hamburg, MD, at an April 16 hearing.
In her testimony, Dr. Hamburg acknowledged that the compounding industry was evolving and required more oversight. Too many deaths and injuries have resulted from unsafe practices at these facilities, she said. “However, the current legal framework does not provide the FDA with the tools needed to identify and adequately regulate these pharmacies to prevent product contamination.”
The FDA needs a system “that requires these compounding facilities to register with us so we know who they are,” she said.
Republicans on the panel remained skeptical about the FDA’s handling of the Massachusetts facilities. It’s unclear why the agency never inspected NECC or Ameridose but had inspected other compounding facilities after the outbreak, said Rep. Bill Johnson (R, Ohio). “What causes you enough alarm to want to go inspect? If event reports that say public health is in danger and that lives are in danger … if that’s not enough, I’d like to be able to understand that.”
State pharmacy boards currently regulate the quality and safety of compounding pharmacies. Although thousands of pharmacies specialize in compounding, only a handful have been accredited.
David Ball, a spokesman for the International Academy of Compounding Pharmacists, said the approximately 30 inspections the FDA recently conducted shows that the agency already has adequate authority to look into questionable practices or problems.
The events discussed at the hearing revealed that the FDA failed to take prompt action, Ball said. But to prevent similar incidents as the meningitis outbreak, “the State Boards of Pharmacy that regulate compounding need to have open communication with the FDA. IACP has recommended and continues to advocate for changes and improvements to the state regulation of compounding pharmacies.”

Doctors debate federal monitoring

Other observers aren’t convinced that state regulation is the answer. “Every state is different,” said Timothy Deer, MD, an anesthesiologist and a member of the board of directors of the American Academy of Pain Medicine. “You may see some states that are more relaxed than other states. So I think accrediting should be mandatory and monitored by the federal government, and that would certainly improve safety.”
Accrediting is voluntary now, Dr. Deer added. In his view, any compounding pharmacy that makes a drug that’s injected, taken orally or infused should require accreditation.
Michael Schafer, MD, communications Cabinet chair at the American Academy of Orthopaedic Surgeons, said it should be up to the FDA to determine what changes should be made regarding the regulation of compounding pharmacies. “We have been proactively educating and updating our members on this issue since the initial reports of concern came to our attention,” he said. “Any time patients are at risk from a medical product or procedure, we certainly have to determine if there is more we can do to mitigate risks.”
In a health alert issued March 4, the Centers for Disease Control and Prevention advised physicians to remain aware of any signs and symptoms indicative of meningitis after the Massachusetts outbreak. Although the outbreak first was reported in September 2012, the CDC cautioned that the infection had a prolonged incubation period.
None of the patients in Dr. Deer’s practice uses compounded steroids, and they weren’t at risk during the meningitis outbreak. If a physician does have patients at risk, the patients should be contacted and informed on what the signs are for this infection, he advised. Collaboration with other physicians also is crucial, he said. “If it’s an infectious risk like this was, I think it’s important to reach out to the infectious disease doctors who have more expertise than the anesthesiologist doing the injection would have, and get their input.”

ADDITIONAL INFORMATION

Multiple incidents tied to compounded products

Food and Drug Administration Commissioner Margaret Hamburg, MD, said at an April 16 House committee hearing that the agency planned to be more aggressive about monitoring compounding facilities, but that it needed more regulatory authority over this industry. In her testimony, Dr. Hamburg outlined several incidents during the past decade in which compounded products led to serious injuries or deaths.
  • 2012: Fungal meningitis outbreak associated with a contaminated injectable steroid distributed by the New England Compounding Center results in about 700 illnesses, with more than 50 deaths.
  • 2012: Contaminated sterile ophthalmic drugs cause fungal eye infections in 43 patients.
  • 2011: Nineteen bacterial infections, including nine deaths, result from contaminated total parenteral nutrition products.
  • 2007: Texas compounder sells colchicine that is 640% the labeled strength, resulting in three people dying from organ failure.
  • 2005: Five cases of severe system inflammatory infections, three of which result in death, are caused by contaminated cardioplegia solution.
  • 2001: Three patients die and others receive medical care or are hospitalized after injections of a contaminated steroid solution.
Source: Testimony of Margaret Hamburg, MD, Food and Drug Administration commissioner, before the House Energy and Commerce oversight and investigations subcommittee, April 16 (link)
quoted from here

Senate Bill Gains Major Support to Increase FDA Muscle on Drug Compounders Senate Bill Gains Major Support to Increase FDA Muscle on Drug Compounders April 29th, 2013 // 12:52 pm


Not long after a nationwide fungal meningitis outbreak that was found to have been caused by a drug compounding pharmacy, 35 US senators have put together draft legislation that would boost FDA oversight of compounders and also would have a list of strict requirements for these pharmacies to do business.
This bill would allow the agency to pinpoint certain types of drugs that may not be compounded. The bill also would make distinctions on acts that are associated with regular compounding, by putting restrictions on what is thought to be distribution wholesale of compounded products. Compounders also would be charged a fee of $15,000. This would help to increase FDA’s tight budget.
The bill also noted that compounders have to register with the agency and inform them of products they are making. Production must be supervised by a pharmacist at the state level and the company must comply with all FDA cGMP guidelines. All adverse events have to be reported. There has to be better communications with state pharmacy boards. And only ingredients that are in compliance with the US Pharmacopeia can be utilized.
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Compliance Blog: Draft bill gives FDA authority over some pharmacie...

Compliance Blog: Draft bill gives FDA authority over some pharmacie...: The Food and Drug Administration would gain greater authority over pharmacies that compound sterile drugs and ship them across state line...

Duane Morris Summary of New Federal Draft Legislation


ALERTS AND UPDATES

Congress Drafts Compounding Legislation -- Defines Compounded Drugs as "New Drugs" Under the FFDCA and Creates Bright Line Between "Traditional Compounders" and "Compounding Manufacturers"

April 29, 2013
While the Proposal's creation of two new regulatory categories for traditional compounders and compounding manufacturers represents a significant change, the most sweeping change under the Proposal is the inclusion of compounded drugs as a "new drug" under the Federal Food, Drug, and Cosmetic Act.
In the wake of the New England Compounding Center meningitis outbreak, the federal government has actively pushed for greater legislative oversight over compounding pharmacies. On April 26, 2013, the U.S. Senate Committee on Health, Education, Labor & Pensions ("HELP") releasedproposed legislation ("Proposal") aimed at regulating compounding pharmacies. The Proposal makes compounds "new drugs" under the Federal Food, Drug, and Cosmetic Act ("FFDCA"), subjecting all compounds to federal regulation. The Proposal also draws a bright line, defining some compounders as "traditional compounders," and creates a new category called "compounding manufacturers." While the legislation has a long road until it becomes law, compounding pharmacies should consider closely analyzing the provisions now, as the Proposal fundamentally changes the regulation of compounding pharmacies.

What Is a "Compounding Manufacturer" Under the Proposal?

Compounding pharmacies are presently licensed under state pharmacy laws. The Proposal, however, divides compounding pharmacies into two categories for purposes of federal regulation: (1) traditional compounders and (2) compounding manufacturers.
Under the Proposal, a traditional compounder would be limited to entities where a drug is compounded by a licensed pharmacist, physician or veterinarian that compounds the drug either (1) upon receipt of a prescription order for an identified individual patient or (2) in limited quantities before receipt of a prescription order for an identified individual patient in certain limited circumstances.1 Although a traditional compounder would continue to be state licensed pharmacies, under the Proposal, it would be subject to additional federal requirements.
However, a compounding manufacturer would be defined as an entity that compounds a sterile drug prior to receiving a prescription and introduces the drug into interstate commerce.2 The new definition of compounding manufacturer also includes entities that pool sterile products or that repackage sterile, single-use, preservative-free vials. Under the Proposal, compounding manufacturers cannot be licensed as pharmacies under state laws.

What Are the New Requirements Under the Proposal?

While the Proposal's creation of two new regulatory categories for traditional compounders and compounding manufacturers represents a significant change, the most sweeping change under the Proposal is the inclusion of compounded drugs as a "new drug" under the FFDCA. This creates a presumption that compounded drugs are subject to the FFDCA's registration, new drug, manufacturing practices and other requirements, unless an exemption applies.
If any entity meets the new definition of a traditional compounder, it would be exempt from the FFDCA requirements for Current Good Manufacturing Practices ("CGMPs"), adequate directions for use regulations and the new drug provisions.
If an entity meets the definition of a compounding manufacturer, it would be exempt from the new drug and adequate directions for use regulations. Significantly, however, compounding manufacturers would be required to comply with the CGMPs and would not be exempt from the FFDCA's registration and inspection exemptions.
The Proposal would also require compounding manufacturers to:
  • Compound products under the direct oversight of a pharmacist licensed in the state in which the compounder is located.
  • Make biannual reports of drugs sold.
  • Report serious adverse events within 15 days; investigate, follow up and report adverse event experiences; and maintain records of adverse events for 10 years.
  • Develop enhanced labeling that includes a statement identifying the drug as a compounded drug. Compounded drugs without these labels will be deemed misbranded.
  • Pay a $15,000 annual fee designed to defray the costs for inspection and regulation.3
Finally, the Proposal identifies three categories of drugs that may not be compounded: (1) complex dosage forms and biologics, (2) marketed drugs or "copies" and (3) drugs removed from the market based on safety and efficacy concerns.

Limitations on the Sale of Compounded Drugs

The Proposal also imposes certain limitations on the sale of compounded drugs. Compounded drugs, whether from a traditional compounder or compounding manufacturer, may not be sold by an entity other than the compounding manufacturer or traditional compounder that compounded the drug. Similarly, the compounded drug may not be sold to an entity other than a healthcare entity that provides medical services through licensed prescribers directly to patients, except in cases where a traditional compounder dispenses the drug directly to an individual or in inter-corporate transfers to a licensed pharmacy for the sole purpose of dispensing compounded drugs to the end user for self-administration. Drugs sold to healthcare entities must also be marked "not for resale."

Criminal Penalties

It is important to note that the Proposal makes it unlawful to resell a compounded drug that is labeled "not for resale." These sales are not prohibited under the FFDCA and carry penalties of up to one year in prison and/or up to a $1,000 fine. Additional penalties may be imposed if the resale is committed with the intent to defraud or mislead; such sales are punished by up to three years in prison and/or up to a $10,000 fine.
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