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Archive of Updates

December 12, 2012
November 30, 2012
November 20, 2012
November 2, 2012
November 1, 2012
October 26, 2012
October 22, 2012
October 18, 2012
October 16, 2012
October 15, 2012
October 12, 2012
October 6, 2012
October 5, 2012 

[12-12-2012] FDA and CDC have identified bacterial and/or fungal contamination in unopened vials of betamethasone, cardioplegia, and triamcinolone solutions distributed and recalled from NECC. These include bacteria known as Bacillus, and fungal species including Aspergillus tubingensis,  Aspergillus fumigatus,  Cladosporium species,and Penicillium species.  Although rare, some of the identified Bacillus species can be human pathogens.  Some of the fungal organisms identified, particularly Aspergillus fumigatus, are known to cause disease in humans.  It is not known how product contamination with these organisms could affect patients clinically.  See CDC’s Advice for Clinicians.

CDC and FDA Laboratory-Confirmed Organisms from Product Samples

Laboratory-Confirmed Organisms from Product Samples Associated with
NECC Recalled Lots of Betamethasone, Cardioplegia, and Triamcinolone Solutions

MedicationLot NumberBacterial and Fungal Contamination
Betamethasone
6 mg/mL injectable –5 mL per vial
08202012@141Paenibacillus pabuli/amolyticus, Bacillus idriensis, Bacillus flexus, Bacillus simplex, Lysinibacillus sp., Bacillus niacini, Kocuria rosea,
Bacillus lentus
Betamethasone
6 mg/mL injectable –5 mL per vial
07032012@22Bacillus niabensis, Bacillus circulans
Betamethasone
12 mg/mL injectable – 5 mL per vial
07302012@52Bacillus lentus, Bacillus circulans, Bacillus niabensis, Paenibacillus barengoltzii/timonensis
Betamethasone
6mg/mL injectable – 5 mL per vial
08202012@44Bacillus lentus, Bacillus firmus, Bacillus pumilus
Betamethasone
6 mg/mL injectable – 5 mL per vial
08152012@84Penicillium sp., Cladosporium sp.

Triamcinolone
40mg/mL injectable – 1 mL per vial
06062012@6Bacillus lentus, Bacillus circulans, Bacillus niabensis, Bacillus nealsonii, Bacillus subtilis group, Bacillus firmus
Triamcinolone
40 mg/mL injectable – 2 mL per vial
08172012@60Aspergillus tubingensis, Penicillium sp.
Triamcinolone
40mg/mL injectable – 10 mL per vial
08242012@2Aspergillus fumigatus
Cardioplegia solution
265.5 mL per bag
09242012@55Bacillus halmapalus/horikoshii, Brevibacillus choshinensis

[11-30-2012] FDA and CDC have identified bacterial and/or fungal contamination in unopened vials of betamethasone, cardioplegia, and triamcinolone solutions distributed and recalled from NECC. These include bacteria known as Bacillus, and fungal species including Aspergillus tubingensis,  Aspergillus fumigatus,  Cladosporium species,and Penicillium species.  Although rare, some of the identified Bacillus species can be human pathogens.  Some of the fungal organisms identified, particularly Aspergillus fumigatus, are known to cause disease in humans.  It is not known how product contamination with these organisms could affect patients clinically.  See CDC’s Advice for Clinicians.

CDC and FDA Laboratory-Confirmed Organisms from Product Samples

Laboratory-Confirmed Organisms from Product Samples Associated with
NECC Recalled Lots of Betamethasone, Cardioplegia, and Triamcinolone Solutions

MedicationLot NumberBacterial and Fungal Contamination
Betamethasone
6 mg/mL injectable –5 mL per vial
08202012@141Paenibacillus pabuli/amolyticus, Bacillus idriensis, Bacillus flexus, Bacillus simplex, Lysinibacillus sp., Bacillus niacini, Kocuria rosea,
Bacillus lentus
Betamethasone
6 mg/mL injectable –5 mL per vial
07032012@22Bacillus niabensis, Bacillus circulans
Betamethasone
12 mg/mL injectable – 5 mL per vial
07302012@52Bacillus lentus, Bacillus circulans, Bacillus niabensis, Paenibacillus barengoltzii/timonensis
Betamethasone
6mg/mL injectable – 5 mL per vial
08202012@44Bacillus lentus, Bacillus firmus, Bacillus pumilus
Betamethasone
6 mg/mL injectable – 5 mL per vial
08152012@84Penicillium sp., Cladosporium sp.

Triamcinolone*
40mg/mL injectable – 1 mL per vial
06062012@6Bacillus lentus, Bacillus circulans
Triamcinolone
40 mg/mL injectable – 2 mL per vial
08172012@60Aspergillus tubingensis, Penicillium sp.
Triamcinolone
40mg/mL injectable – 10 mL per vial
08242012@2Aspergillus fumigatus
Cardioplegia solution
265.5 mL per bag
09242012@55Bacillus halmapalus/horikoshii, Brevibacillus choshinensis

*Other identification of bacteria are pending for this product

[11-20-2012] **The chart is updated to include new culture results

[11-02-2012] *The chart is updated to include additional species of Bacillus bacteria.

[11-01-2012] The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) are reporting laboratory results from samples of two additional recalled NECC products – preservative-free injectable betamethasone and cardioplegia solution. Previously, the fungus Exserohilum rostratum was identified in NECC-supplied, preservative-free methylprednisolone acetate (MPA).

The FDA and CDC laboratories have identified bacteria present in three separate lots (batches) of NECC-supplied preservative-free injectable betamethasone, with each lot producing different culture results, and in a single lot of NECC cardioplegia solution.  

Medication

Lot number

Microbial contamination

Betamethasone 6 mg/mL injectable – 5 mL per vial

08202012@141

Paenibacillus pabuli/amolyticus, Bacillus idriensis, Bacillus flexus, Bacillus simplex, Lysinibacillus sp., *Bacillus niacin, ** Koceria rosea, **Bacillus lentus

Betamethasone 6 mg/mL injectable – 5 mL per vial

07032012@22

Bacillus niabensis, Bacillus circulans

Betamethasone 12 mg/mL injectable – 5 mL per vial

07302012@52

Bacillus lentus, Bacillus circulans, *Bacillus niabensis, Paenibacillus barengoltzii/timonensis

**Betamethasone 6 mg/mL injectable – 5 mL per vial

08202012@44

Bacillus lentus, Bacillus firmus, Bacillus pumilus

**Betamethasone 6 mg/mL injectable – 5 mL per vial

08152012@84

Fungal growth – identification pending

**Triamcinolone 40 mg/mL injectable – 1 mL per vial

06062012@6

Bacillus lentus, Bacillus circulans

**Triamcinolone 40 mg/mL injectable – 2 mL per vial

08172012@60

Fungal growth – identification pending

**Triamcinolone 40 mg/mL injectable – 10 mL per vial

08242012@2

Fungal growth – identification pending

Cardioplegia solution
265.5 mL per bag

09242012@55

*Bacillus halmapalus/horikoshii, Brevibacillus choshinensis

The clinical significance of these results is not known. Both Bacillus idriensis and Bacillus circulans have been rarely reported as a cause of human disease. CDC continues to investigate reports of potential infections in patients receiving other NECC products. As of Nov. 1, CDC has not received reports of laboratory-confirmed cases of infection due to Bacillus or closely related organisms linked to betamethasone or cardioplegia solution from NECC.

Although final laboratory results on additional samples are still pending, the findings of fungal contamination of MPA, injectable betamethasone, and injectable triamcinolone, and bacterial contamination of injectable betamethasone, injectable triamcinolone and cardioplegia solution reinforce the FDA’s concern about the lack of sterility in products produced at NECC’s compounding facility and serve to underscore that hospitals, clinics, and health care providers should not use any NECC-supplied products. All NECC products are subject to NECC’s recall announced on Oct. 6, 2012.

As previously confirmed by the CDC and FDA, the fungus Exserohilum rostratum was identified from 2 different lots of NECC-supplied, preservative-free MPA (Lot #06292012@26 and Lot #08102012@51), which have been associated with the outbreak of fungal meningitis and other infections in patients. Testing on the third implicated lot of MPA (Lot #05212012@68), as well as other NECC products, is ongoing.

Health care professionals and patients may call the FDA's Drug Information Line at 855-543-DRUG (3784) and press * to get the most recent information regarding the Ameridose recall and speak directly to a pharmacist.

The FDA asks health care professionals and consumers to report any adverse reactions to the FDA's MedWatch Program by fax at 800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch

 


 

[11-02-12] *The chart is updated to include additional species of Bacillus bacteria.

[11-01-2012 -- Update on NECC Products: Samples of injectable betamethasone and cardioplegia solution test positive for bacterial contamination]

The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) are reporting laboratory results from samples of two additional recalled NECC products – preservative-free injectable betamethasone and cardioplegia solution. Previously, the fungus Exserohilum rostratum was identified in NECC-supplied, preservative-free methylprednisolone acetate (MPA).

The FDA and CDC laboratories have identified bacteria present in three separate lots (batches) of NECC-supplied preservative-free injectable betamethasone, with each lot producing different culture results, and in a single lot of NECC cardioplegia solution.  

Medication

Lot number

Microbial contamination

Betamethasone 6 mg/mL injectable – 5 mL per vial08202012@141Paenibacillus pabuli/amolyticus, Bacillus idriensis, Bacillus flexus, Bacillus simplex, Lysinibacillus sp., *Bacillus niacini
Betamethasone 6 mg/mL injectable – 5 mL per vial07032012@22Bacillus niabensis, Bacillus circulans
Betamethasone 12 mg/mL injectable – 5 mL per vial07302012@52Bacillus lentus, Bacillus circulans, *Bacillus niabensis, Paenibacillus barengoltzii/timonensis
Cardioplegia solution
265.5 mL per bag
09242012@55*Bacillus halmapalus/horikoshii, Brevibacillus choshinensis

The clinical significance of these results is not known. Both Bacillus idriensis and Bacillus circulans have been rarely reported as a cause of human disease. CDC continues to investigate reports of potential infections in patients receiving other NECC products. As of Nov. 1, CDC has not received reports of laboratory-confirmed cases of infection due to Bacillus or closely related organisms linked to betamethasone or cardioplegia solution from NECC.

Fungal cultures for injectable betamethasone and cardioplegia solution are pending and the presence of additional microbial organisms and/or fungus in these products cannot be ruled out at this time.

Although final laboratory results on additional samples are still pending, the previous finding of fungal contamination of MPA and recent finding of bacterial contamination of injectable betamethasone and cardioplegia solution reinforce the FDA’s concern about the lack of sterility in products produced at NECC’s compounding facility and serve to underscore that hospitals, clinics, and health care providers should not use any NECC-supplied products. All NECC products are subject to NECC’s recall announced on Oct. 6, 2012.

As previously confirmed by the CDC and FDA, the fungus Exserohilum rostratum was identified from 2 different lots of NECC-supplied, preservative-free MPA (Lot #06292012@26 and Lot #08102012@51), which have been associated with the outbreak of fungal meningitis and other infections in patients. Testing on the third implicated lot of MPA (Lot #05212012@68), as well as other NECC products, is ongoing.

Health care professionals and patients may call the FDA's Drug Information Line at 855-543-DRUG (3784) and press * to get the most recent information regarding the Ameridose recall and speak directly to a pharmacist.

The FDA asks health care professionals and consumers to report any adverse reactions to the FDA's MedWatch Program by fax at 800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch


[10-26-2012 -- FDA reports conditions observed at New England Compounding Center facility]

 
Today, the U.S. Food and Drug Administration released a copy of the FDA Form 483 issued to the New England Compounding Center (NECC). The FDA observed and has since confirmed contaminated products and listed a number of observations regarding conditions in the clean room at NECC’s Framingham, Mass. facility.

Related Information


 

[Update: 10-22-2012 -- FDA provides NECC Customer List]

New England Compounding Center Customer Lists

On October 4, 2012, FDA advised medical professionals that all products produced by New England Compounding Center (NECC) should be retained, secured, and withheld from use. On October 6, NECC announced a voluntary recall of all its products currently in circulation that were compounded at and distributed from its Framingham, Massachusetts facility. A complete list of all NECC products subject to this recall can be accessed here   [HTML | PDF].  On October 15, 2012, FDA further advised healthcare providers to follow-up with patients who were administered any NECC injectable product on or after May 21, 2012, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution purchased from or produced by NECC.

Today, FDA is making available two lists of customers (consignees) who received products that were shipped on or after May 21, 2012 from New England Compounding Center’s Framingham, MA facility. The first list includes customer names and addresses, organized by state.  The second list contains the same basic information as the first list, but is organized alphabetically by customer name and also includes the specific products shipped, the quantities of product shipped, and the shipping date.  The lists were prepared based on information provided by NECC, and FDA cannot vouch for the completeness or accuracy of the lists.  Products shipped by NECC may be missing from the list and facility information may be incomplete. Nevertheless, this is the best information we have available, at this time, to help inform facilities and healthcare providers of NECC products shipped to their facilities since May 21, 2012.

FDA is reiterating and updating its previous recommendation that follow-up with patients be done when the following three conditions are met:

  • The medication was an injectable product purchased from or produced by NECC, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution,
  • The medication was shipped by NECC on or after May 21, 2012, and
  • The medication was administered to patients on or after May 21, 2012.

Since the May 21, 2012 date is the date the first of three lots of methylprednisolone acetate implicated in the current outbreak was produced, products produced and shipped by NECC on or after May 21, 2012 are believed at this time to be of greatest risk of contamination.  Now that we have shipping information available, we are updating FDA’s recommendation to health care providers so that they can focus their attention on following up with the patients who are believed to be at greatest risk of receiving a contaminated product.

Advice to NECC Customers

Customers identified on these lists should check their stocks to identify whether they have any products from the New England Compounding Center (NECC), and they should immediately isolate any identified product from their drug supplies.  All NECC products are subject to voluntary recall.  Customers with product on hand should contact NECC at 1-800-994-6322 or via fax at 508-820-1616 to obtain instructions on how to return products to NECC.

Advice to Patients

Patients who believe they received an injection or other product that was shipped by NECC on or after May 21, 2012 should remain vigilant for the signs and symptoms of infection, and contact their health care provider if they are concerned.  The meningitis outbreak has occurred in patients who received injections near the spine (back or neck).  The signs and symptoms of meningitis include fever, headache, stiff neck, nausea and vomiting, photophobia (sensitivity to light) and altered mental status.  Symptoms for infections following other types of injections at other body sites may vary, and are not limited to meningitis.  Other possible infections at other parts of the body (e.g., peripheral joints) may include fever; swelling, increasing pain, redness, warmth at an injection site; visual changes, pain, redness or discharge from the eye; chest pain, or drainage from the surgical site (infection within the chest).  Patients should contact their healthcare provider if they have any of these signs or symptoms. 

Patients who received an NECC product prior to May 21, 2012 and who have not experienced symptoms of infection to date are at less risk of infection because of the amount of time that has elapsed since that date.  FDA is not recommending these patients follow-up with their healthcare providers unless they are experiencing symptoms of infection.

Advice to Healthcare Professionals

FDA advises healthcare professionals to follow-up with patients who have been administered an injectable product shipped by NECC on or after May 21, 2012, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution.  FDA does not urge patient follow-up at this time for NECC products of lower risk such as topicals (for example, lotions, creams, eyedrops not used in conjunction with surgery) and suppositories, or for patients who may have received an NECC product in these categories before May 21, 2012.  Patients who received an NECC product prior to May 21, 2012 and who have not experienced symptoms of infection to date are at less risk of infection because of the amount of time that has elapsed since that date.  FDA is not recommending that healthcare providers follow-up with these patients unless they have reported symptoms of infection.

Health care professionals should retain and secure all remaining products purchased from NECC.  All NECC products are subject to voluntary recall.  Clinics or customers with product on hand should contact NECC at 1-800-994-6322 or via fax at 508-820-1616 to obtain instructions on how to return products to NECC.

Clinicians and patients are also requested to report any suspected adverse events following use of these products to FDA's MedWatch program at 1-800-332-1088 or www.fda.gov/medwatch.

Healthcare professionals and patients may dial FDA’s Drug Information Line at 855-543-DRUG (3784) and press * to get the most recent information regarding the meningitis recall and speak directly to a pharmacist.

If you have identified NECC customers who received product that do not appear on these lists, please contact FDA’s Drug Information Line to report this problem.

FDA continues its investigation and may issue additional public communications as appropriate. 


[10-18-2012] CDC and FDA have confirmed the presence of a fungus known as Exserohilum rostratum in unopened medication vials of preservative-free methylprednisolone acetate (80mg/ml) from one of the three implicated lots from NECC (Lot #08102012@51, BUD 2/6/2013).  The laboratory confirmation further links steroid injections from these lots from NECC to the multistate outbreak of fungal meningitis and joint infections.  Testing on the other two implicated lots of methylprednisolone acetate and other NECC injectables continues. 

CDC and state health departments estimate that approximately 14,000 patients may have received injections with medication from three implicated lots of methylprednisolone and nearly 97% of these patients have been contacted for further follow-up.  


*UPDATE, 10-16-2012: On 10-15-12 the health care facility notified CDC that the initial report of two transplant patients has been revised to one patient who received cardioplegia solution from NECC. The 10-15-12 statement has been revised to reflect this information.

en Español 


[10-15-2012] As a result of FDA, CDC, and state health departments' ongoing investigation of contamination at the New England Compounding Center's (NECC) Framingham, Massachusetts facility, on October 4, the FDA advised providers to not use any NECC products. On October 6, NECC announced a recall of all its products. A complete list of all products subject to this recall can be accessed here [HTML | PDF]. The FDA had previously issued guidance for medical professionals that all products distributed by NECC should be retained, secured, and withheld from use.   

Also as a result of the ongoing investigation of NECC, a patient with possible meningitis potentially associated with epidural injection of an additional NECC product, triamcinolone acetonide, has been identified through active surveillance and reported to FDA. Triamcinolone acetonide is a type of steroid injectable product made by NECC. The cases of meningitis identified to date have been associated with methylprednisolone acetate, another similar steroid injectable product.

In addition, one transplant patient with Aspergillus fumigatus infection who was administered NECC cardioplegic solution during surgery has been reported. An investigation of this patient is ongoing; and there may be other explanations for their Aspergillus infection. Cardioplegic solution is used to induce cardiac muscle paralysis during open heart surgery to prevent injury to the heart.*

FDA continues to evaluate these reports, and when the agency obtains additional information, it will be promptly relayed to the public. FDA has not confirmed that these two infections were, in fact, caused by an NECC product.

At this point in FDA's investigation, the sterility of any injectable drugs, including ophthalmic drugs that are injectable or used in conjunction with eye surgery, and cardioplegic solutions produced by NECC are of significant concern, and out of an abundance of caution, patients who received these products should be alerted to the potential risk of infection. At this time, no cases of infection have been reported in connection with any NECC-produced ophthalmic drug that is injectable or used in conjunction with eye surgery, but FDA believes this class of products could present potentially similar risks of infection. Products from NECC can be identified by markings that indicate New England Compounding Center by name or by its acronym (NECC), and/or the company logo that can be accessed here.

FDA Advice to Healthcare Practitioners

The FDA had previously issued guidance for medical professionals that all products distributed by NECC should be retained, secured, and withheld from use. Based on the new information described above, out of an abundance of caution, FDA advises that if you administered an NECC injectable product to a patient after May 21, 2012, including an ophthalmic drug that is injectable or used in conjunction with eye surgery or a cardioplegic solution, you follow-up with that patient. FDA does not urge patient follow-up at this time for NECC products of lower risk such as topicals (for example, lotions, creams, eyedrops not used in conjunction with surgery) and suppositories.

You should inform patients who received the NECC products noted above of the symptoms of possible infection and instruct them to contact you or another healthcare provider immediately if they experience any of these symptoms.

The signs and symptoms of meningitis include fever, headache, stiff neck, nausea and vomiting, photophobia (sensitivity to light) and altered mental status. Symptoms for other possible infections may include fever; swelling, increasing pain, redness, warmth at injection site; visual changes, pain, redness or discharge from the eye; chest pain, or drainage from the surgical site (infection within the chest).

The FDA recognizes that some health care professionals may receive a high volume of calls from patients or be concerned about having to notify many patients as a result of today's announcement. We ask you to use your clinical judgment in deciding which patients are at risk and contact those patients in whatever communications mode you prefer, whether it is email, phone or letter. Face-to-face communication with patients is not necessary.

Clinicians are also requested to report any suspected adverse events following use of these products to FDA's MedWatch program at 1-800-332-1088 or www.fda.gov/medwatch.

Health care professionals may dial FDA's Drug Information Line at 855-543-DRUG (3784) and press * to get the most recent information regarding the meningitis recall and speak directly to a pharmacist.


[UPDATE: 10-12-2012] FDA is continuing to actively investigate this situation.  It is our goal to contain the health risk as quickly as possible.  FDA considers this to be one of our top priorities and we are dedicating  many resources to this investigation.   As part of the ongoing FDA investigation, FDA has confirmed the presence of a fungal contaminant in multiple sealed vials of methylprednisolone acetate injection, made by the New England Compounding Center’s (NECC) Framingham, Massachusetts site and from samples collected around the country.

FDA, in partnership with CDC, is in the process of attempting to identify the exact species of fungus isolated from the sealed vials and whether the fungus is the same as one of the two fungal organisms found in patients.

As part of the ongoing investigation, FDA’s investigators have collected samples of materials from the NECC facility in Framingham, Massachusetts, and from clinical facilities around the country that reported ill patients and/or had retained quantities of methylprednisolone acetate compounded by NECC. FDA is also reviewing the processes, procedures, and documentation at the facility.

Given the preliminary findings of the investigation of NECC, as a precaution, FDA urges patients who believe they received an injection or other product compounded by NECC to remain vigilant for the signs and symptoms of infection, including meningitis. The signs and symptoms of meningitis include fever, headache, stiff neck, nausea and vomiting, photophobia (sensitivity to light) and altered mental status. Clinics, doctors' offices, and hospitals who used NECC products should advise concerned patients that have been given NECC products to seek medical care upon the onset of symptoms of infection.

Based on the business relationship between NECC and Ameridose, FDA and the Massachusetts Board of Pharmacy launched a joint inspection at the Ameridose facility in Westborough, Massachusetts on October 10, 2012. As part of our efforts to protect the public health, FDA is investigating whether certain aspects of compounding practices and facility conditions observed at NECC may be present at the Ameridose facility. FDA will review whether Ameridose has procedures and facilities necessary to safely produce and provide sterile drug products. At this time, there is no known contamination of products produced by Ameridose. 


[UPDATE: 10-6-2012] On October 6, 2012, the New England Compounding Center (NECC), following an earlier recommendation by FDA that none of the firm's compounded products be used, announced a voluntary recall of all products currently in circulation that were compounded at and distributed from its facility in Framingham, Massachusetts.


[10-5-2012] FDA is working closely with the CDC and state partners to investigate an outbreak of meningitis among patients who had received an epidural steroid injection.  Investigation into the exact source of the outbreak is still ongoing, but the outbreak is associated with a potentially contaminated medication. 

That product is preservative-free methylprednisolone acetate (80mg/ml), an injectable steroid produced and distributed by New England Compounding Center (NECC) in Framingham, Massachusetts.  CDC’s interim data show that all infected patients received injection with this product.  As of Oct 3, 2012, NECC has voluntarily shut down.

FDA has observed fungal contamination by direct microscopic examination of foreign matter taken from a sealed vial of methylprednisolone acetate collected from NECC.  FDA is in the process of conducting additional microbial testing to confirm the exact species of the fungus.  As part of the ongoing investigation, FDA will continue to work closely with CDC and state authorities to determine whether this sample taken from the product matches the organism found in patients. We are working diligently to expedite that process.

Out of an abundance of caution, FDA is taking the additional step of recommending that health care professionals and consumers not use any product that was produced by NECC at this time. In addition, FDA requests that health care professionals retain and secure all remaining products purchased from NECC until FDA provides further instructions regarding the disposition of these products. 

NECC press release and a complete list of the firm's compounded products.