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Correspondence |

Unapproved Prescription Cough, Cold, and Allergy MedicationsUnapproved Cough Medications FREE TO VIEW

Charles E. Lee, MD; Craig Ostroff, PharmD; Judith McMeekin, PharmD; Stanley Shepperson, PharmD; Ian Deveau, PhD
Author and Funding Information

From the Office of Unapproved Drugs and Labeling Compliance (Drs Lee, McMeekin, Shepperson, Deveau); and Office of Compliance, Center for Drug Evaluation and Research, US Food and Drug Administration, and Archimedes Pharma US, Inc (Dr Ostroff).

Correspondence to: Charles E. Lee, MD, US Food and Drug Administration, 10903 New Hampshire Ave, Bldg 51, Room 5184, Silver Spring, MD 20993-0002; e-mail: charles.lee@fda.hhs.gov

Financial/nonfinancial disclosures: The authors have reported to CHEST the following conflicts of interest: Dr Lee has made public statements while acting as clinical lead in media and press briefings regarding the subject of this article. Dr Ostroff is currently an employee of Archimedes Pharma US, Inc, and is a former employee of Cephalon, Inc; Schering-Plough Corporation; and CORE Regulatory Consulting LLC. He holds shares in both Cephalon, Inc, and Merck. These relationships are not related to the topic of this article. Drs McMeekin, Shepperson, and Deveau have reported that no potential conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (http://www.chestpubs.org/site/misc/reprints.xhtml).


Financial/nonfinancial disclosures: The authors have reported to CHEST the following conflicts of interest: Dr Lee has made public statements while acting as clinical lead in media and press briefings regarding the subject of this article. Dr Ostroff is currently an employee of Archimedes Pharma US, Inc, and is a former employee of Cephalon, Inc; Schering-Plough Corporation; and CORE Regulatory Consulting LLC. He holds shares in both Cephalon, Inc, and Merck. These relationships are not related to the topic of this article. Drs McMeekin, Shepperson, and Deveau have reported that no potential conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article.

Financial/nonfinancial disclosures: The authors have reported to CHEST the following conflicts of interest: Dr Lee has made public statements while acting as clinical lead in media and press briefings regarding the subject of this article. Dr Ostroff is currently an employee of Archimedes Pharma US, Inc, and is a former employee of Cephalon, Inc; Schering-Plough Corporation; and CORE Regulatory Consulting LLC. He holds shares in both Cephalon, Inc, and Merck. These relationships are not related to the topic of this article. Drs McMeekin, Shepperson, and Deveau have reported that no potential conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (http://www.chestpubs.org/site/misc/reprints.xhtml).

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (http://www.chestpubs.org/site/misc/reprints.xhtml).


Chest. 2011;140(6):1672-1673. doi:10.1378/chest.11-2129
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In a recent issue of CHEST (August 2011), Irwin and Smith1 wrote an editorial on a commentary about the recent US Food and Drug Administration (FDA) enforcement action2 on marketed unapproved prescription cough, cold, and allergy medications.3 We appreciate the opportunity to provide insight into our action, which affects the American College of Chest Physicians cough guidelines.4 We also thank Irwin and Smith for their support of our action.

Irwin and Smith1 suggested that extended-release products compounded by state-licensed compounding pharmacies represent an additional option to address the lack of extended-release, first-generation antihistamines and extended-release, first-generation antihistamine/pseudoephedrine combination products. They recommended that such products be compounded to meet United States Pharmacopeia–National Formulary standards.5

We would like to point out that the United States Pharmacopeia–National Formulary5 does not contain any standard or specification for any compounded extended-release drug product and, therefore, cannot by itself be a reference for the compounding of extended-release cough, cold, and allergy drug products. A compounding pharmacy would need to develop a drug formulation that had appropriate potency, purity, and performance characteristics to consistently yield a safe and effective product. Here, the compounding pharmacy would be faced with the same challenges, but with fewer resources, as drug manufacturers have in developing and testing an extended-release drug product that could be relied upon by physicians and patients, while avoiding problems with safety, efficacy, dose dumping, and product-to-product variability. These are the same concerns that the FDA has with other unapproved compounded or manufactured extended-release drugs. For these reasons, the FDA recommends that practitioners not attempt to have pharmacists compound versions of the cough, cold, and allergy drug products as substitutes for those that were subject to the recent enforcement action of the FDA. Although the authors stress that it is important for clinicians to have an open dialogue with the compounding pharmacy regarding appropriate quality-control testing of compounded products, we have concerns that this option may not be a practical solution to the lack of availability of such products and recommend that practitioners instead rely on products of proven efficacy and safety, as recommended in Ostroff et al.3

Other contributions: This article reflects the views of the authors and should not be construed to represent views or policies of the US Food and Drug Administration.

Other contributions: This article reflects the views of the authors and should not be construed to represent views or policies of the US Food and Drug Administration.

Irwin RS, Smith BS. Managing cough in the aftermath of the decision of the US Food and Drug Administration to remove unapproved prescription cough medications from the market. Chest. 2011;1402:282-284 [CrossRef] [PubMed]
 
Drugs for human use; unapproved and misbranded oral drugs labeled for prescription use and offered for relief of symptoms of cold, cough, or allergy; enforcement action dates. Fed Regist. 2011;7642:11794-11798
 
Ostroff C, Lee CE, McMeekin J. Unapproved prescription cough, cold, and allergy drug products: recent US Food and Drug Administration regulatory action on unapproved cough, cold, and allergy medications. Chest. 2011;1402:295-300 [CrossRef] [PubMed]
 
Irwin RS, Baumann MH, Bolser DC, et al; American College of Chest Physicians (ACCP) American College of Chest Physicians (ACCP) Diagnosis and management of cough executive summary: ACCP evidence-based clinical practice guidelines. Chest. 2006;129suppl 1:1S-23S [CrossRef] [PubMed]
 
 United States Pharmacopeia–National Formulary 2011. 2011; Rockville, MD United States Pharmacopeia Convention
 

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References

Irwin RS, Smith BS. Managing cough in the aftermath of the decision of the US Food and Drug Administration to remove unapproved prescription cough medications from the market. Chest. 2011;1402:282-284 [CrossRef] [PubMed]
 
Drugs for human use; unapproved and misbranded oral drugs labeled for prescription use and offered for relief of symptoms of cold, cough, or allergy; enforcement action dates. Fed Regist. 2011;7642:11794-11798
 
Ostroff C, Lee CE, McMeekin J. Unapproved prescription cough, cold, and allergy drug products: recent US Food and Drug Administration regulatory action on unapproved cough, cold, and allergy medications. Chest. 2011;1402:295-300 [CrossRef] [PubMed]
 
Irwin RS, Baumann MH, Bolser DC, et al; American College of Chest Physicians (ACCP) American College of Chest Physicians (ACCP) Diagnosis and management of cough executive summary: ACCP evidence-based clinical practice guidelines. Chest. 2006;129suppl 1:1S-23S [CrossRef] [PubMed]
 
 United States Pharmacopeia–National Formulary 2011. 2011; Rockville, MD United States Pharmacopeia Convention
 
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