10. Drug Compounding
The Committee is concerned that, since passage of the Drug Quality and Security Act (DQSA) of
2013, FDA has interpreted provisions of Section 503A of the FDCA in a manner inconsistent
with its legislative intent and with the agency’s own previous positions. Specifically, the FDA
has taken the position that under 503A, a pharmacist may not compound medications prior to
receipt of a prescription and transfer the drugs to a requesting physician or other authorized agent
of the prescriber for administration to his or her patients without a patient-specific prescription
accompanying the medication. This practice, which is often referred to as “office-use”
compounding, is authorized in the vast majority of states and was intended to be allowable under
DQSA. The Committee is aware that in 2012, prior to passage of the DQSA, FDA was working
on a draft compliance policy guide for 503A of the FDCA that provided guidance on how
“office-use” compounding could be done consistent with the provisions of 503A. The
Committee understands the intent of the DQSA was not to prohibit compounding pharmacists
from operation under existing 503A exemptions; therefore, the Committee directs the FDA to
issue a guidance document on how compounding pharmacists can continue to engage in “officeuse”
compounding before the receipt of a patient-specific prescription consistent with the
provisions of 503A within 90 days after the enactment of this Act.
FDA Response: FDA is considering the report language concerning office use in FY 2015 House Report 114- 205. FDA recognizes that sometimes it is necessary for health care practitioners in hospitals, clinics, offices, or other settings to have certain compounded drug products on hand that they can administer to a patient who presents with an immediate need for the compounded drug product. For example, if a patient presents at an ophthalmologist’s office with a fungal eye infection, timely administration of a compounded antifungal medication may be critical to preventing vision loss. In such a case, the prescriber may need to inject the patient with a compounded drug product immediately, rather than writing a prescription and waiting for the drug product to be compounded and shipped to the prescriber. In other cases, compounded drug products may need to be administered by a health care practitioner in his or her office because it would not be safe for the patient to take the drug home for self-administration, and it would not be practical for the patient to bring a prescription for the compounded drug product to a pharmacy and then return to the health care practitioner for administration. SI G N I F I C A N T I T E M S AP P R O P R I A T I O N S CO M M I T T E E S 264 Although compounded drugs can serve an important need, they pose a higher risk to patients than FDA-approved drugs. Compounded drug products are not FDA-approved, which means they have not undergone FDA premarket review for safety, effectiveness, and quality. In addition, licensed pharmacists and licensed physicians who compound drug products in accordance with section 503A are not required to comply with current good manufacturing practice (CGMP) requirements. Furthermore, FDA does not interact with the vast majority of licensed pharmacists and licensed physicians who compound drug products and seek to qualify for the exemptions under section 503A of the FD&C Act for the drug products they compound because these compounders are not licensed by FDA and generally do not register their compounding facilities with FDA. Therefore, FDA is often not aware of potential problems with their compounded drug products or compounding practices unless it receives a complaint such as a report of a serious adverse event or visible contamination. In 2012, contaminated injectable drug products that a compounding pharmacy shipped to patients and health care practitioners across the country caused a fungal meningitis outbreak that resulted in more than 60 deaths and 750 cases of infection. This outbreak was the most serious of a long history of outbreaks associated with contaminated compounded drugs. Since the 2012 fungal meningitis outbreak, FDA has investigated numerous other outbreaks and other serious adverse events, including deaths, associated with compounded drugs that were contaminated or otherwise compounded improperly. FDA has also identified many pharmacies that compounded drug products under insanitary conditions whereby the drug products may have been contaminated with filth or rendered injurious to health, and that shipped the compounded drug products made under these conditions to patients and health care providers across the country, sometimes in large amounts. The longer a compounded sterile drug product that has been contaminated is held by a pharmacist or physician before distribution, or held in inventory in a health care facility before administration, the greater the likelihood of microbial proliferation and increased patient harm. Because of these and other risks, the FD&C Act places conditions on compounding that must be met for compounded drugs to qualify for the exemptions in section 503A. In establishing policies on office use, FDA intends to consider important public health issues, including the need for access to products for office use and the need to protect patients from poor quality compounded products, as well as the statutory language in section 503A of the Federal Food, Drug, and Cosmetic Act, the category of outsourcing facilities created by new section 503B of the Act, and the need to provide a clear line between permissible compounding and impermissible manufacture of unapproved drugs.
quoted from http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/BudgetReports/UCM485237.pdf
FDA Response: FDA is considering the report language concerning office use in FY 2015 House Report 114- 205. FDA recognizes that sometimes it is necessary for health care practitioners in hospitals, clinics, offices, or other settings to have certain compounded drug products on hand that they can administer to a patient who presents with an immediate need for the compounded drug product. For example, if a patient presents at an ophthalmologist’s office with a fungal eye infection, timely administration of a compounded antifungal medication may be critical to preventing vision loss. In such a case, the prescriber may need to inject the patient with a compounded drug product immediately, rather than writing a prescription and waiting for the drug product to be compounded and shipped to the prescriber. In other cases, compounded drug products may need to be administered by a health care practitioner in his or her office because it would not be safe for the patient to take the drug home for self-administration, and it would not be practical for the patient to bring a prescription for the compounded drug product to a pharmacy and then return to the health care practitioner for administration. SI G N I F I C A N T I T E M S AP P R O P R I A T I O N S CO M M I T T E E S 264 Although compounded drugs can serve an important need, they pose a higher risk to patients than FDA-approved drugs. Compounded drug products are not FDA-approved, which means they have not undergone FDA premarket review for safety, effectiveness, and quality. In addition, licensed pharmacists and licensed physicians who compound drug products in accordance with section 503A are not required to comply with current good manufacturing practice (CGMP) requirements. Furthermore, FDA does not interact with the vast majority of licensed pharmacists and licensed physicians who compound drug products and seek to qualify for the exemptions under section 503A of the FD&C Act for the drug products they compound because these compounders are not licensed by FDA and generally do not register their compounding facilities with FDA. Therefore, FDA is often not aware of potential problems with their compounded drug products or compounding practices unless it receives a complaint such as a report of a serious adverse event or visible contamination. In 2012, contaminated injectable drug products that a compounding pharmacy shipped to patients and health care practitioners across the country caused a fungal meningitis outbreak that resulted in more than 60 deaths and 750 cases of infection. This outbreak was the most serious of a long history of outbreaks associated with contaminated compounded drugs. Since the 2012 fungal meningitis outbreak, FDA has investigated numerous other outbreaks and other serious adverse events, including deaths, associated with compounded drugs that were contaminated or otherwise compounded improperly. FDA has also identified many pharmacies that compounded drug products under insanitary conditions whereby the drug products may have been contaminated with filth or rendered injurious to health, and that shipped the compounded drug products made under these conditions to patients and health care providers across the country, sometimes in large amounts. The longer a compounded sterile drug product that has been contaminated is held by a pharmacist or physician before distribution, or held in inventory in a health care facility before administration, the greater the likelihood of microbial proliferation and increased patient harm. Because of these and other risks, the FD&C Act places conditions on compounding that must be met for compounded drugs to qualify for the exemptions in section 503A. In establishing policies on office use, FDA intends to consider important public health issues, including the need for access to products for office use and the need to protect patients from poor quality compounded products, as well as the statutory language in section 503A of the Federal Food, Drug, and Cosmetic Act, the category of outsourcing facilities created by new section 503B of the Act, and the need to provide a clear line between permissible compounding and impermissible manufacture of unapproved drugs.
quoted from http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/BudgetReports/UCM485237.pdf
No comments:
Post a Comment