By Alexander Gaffney, RAC
The issue of pharmaceutical compounding may have dominated much of 2012 and the first half of 2013, but regulators have released few Warning Letters to compounding pharmacies in almost a year, and none since a new trio of compounding guidances came out in December 2013. Now the agency has released its first Warning Letter to a compounding pharmacy in six months, reflecting new authorities and old problems.
The 14 January 2014 letter to Triangle Compounding Pharmacy comes after a February and March 2013 inspection of the company's Cary, NC, facility. The company reportedly compounds sterile drug products, and had already been the subject of a March 2013 FDA Form 483 outlining alleged deficiencies identified at the manufacturing facility after that same inspection.
"During the FDA inspection, investigators observed that your firm does not receive valid prescriptions for individually-identified patients for a portion of the drug products you produce," FDA wrote. "Based on this factor alone, those drugs were not entitled to the statutory exemptions for compounded drugs described in section 503A of the FDCA and did not qualify for the agency’s exercise of enforcement discretion set forth in the CPG."
FDA also noted that since the inspection, Congress and the president enacted the Drug Quality and Security Act (DQSA), which affirmed that the 503A restrictions against compounding products without a valid prescription are "applicable in every federal judicial circuit."
FDA also explained those authorities at length in a trio of guidance documents released in December 2013, and the Warning Letter—in addition to another released on the same day--appears to be the first instance of FDA expressing those authorities.
"FDA investigators noted that your sterile drug products were prepared, packed, or held under unsanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health," the agency wrote in its Warning Letter.
continue to read here
The 14 January 2014 letter to Triangle Compounding Pharmacy comes after a February and March 2013 inspection of the company's Cary, NC, facility. The company reportedly compounds sterile drug products, and had already been the subject of a March 2013 FDA Form 483 outlining alleged deficiencies identified at the manufacturing facility after that same inspection.
503A Violations
While there, FDA inspectors said they determined that the company was not receiving valid prescriptions for individually-identifiable patients—a violation of Section 503A of the Federal Food, Drug and Cosmetic Act (FD&C Act). Regulators said that despite "conflicting judicial decisions regarding the applicability of Section 503A" at the time of the inspection, the relevant sections of 503A and the agency's own Compliance Policy Guidance (460.200) were both applicable and in effect."During the FDA inspection, investigators observed that your firm does not receive valid prescriptions for individually-identified patients for a portion of the drug products you produce," FDA wrote. "Based on this factor alone, those drugs were not entitled to the statutory exemptions for compounded drugs described in section 503A of the FDCA and did not qualify for the agency’s exercise of enforcement discretion set forth in the CPG."
FDA also noted that since the inspection, Congress and the president enacted the Drug Quality and Security Act (DQSA), which affirmed that the 503A restrictions against compounding products without a valid prescription are "applicable in every federal judicial circuit."
FDA also explained those authorities at length in a trio of guidance documents released in December 2013, and the Warning Letter—in addition to another released on the same day--appears to be the first instance of FDA expressing those authorities.
Sterility Concerns
But even outside of the above complaints, FDA maintained that Triangle Compounding has more serious problems related to the sterility of its products."FDA investigators noted that your sterile drug products were prepared, packed, or held under unsanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health," the agency wrote in its Warning Letter.
continue to read here
I quote the WARNING LETTER:
ReplyDelete"During the inspection, the investigators noted that you were not receiving valid prescriptions for individually-identified patients for a portion of the drug products you were producing. ... Based on this inspection, it appears that you are producing drugs that violate the Federal Food, Drug, and Cosmetic Act (FDCA). ... Nevertheless, receipt of valid prescriptions for individually-identified patients prior to distribution of compounded drugs was relevant for both section 503A of the FDCA and the agency’s Compliance Policy Guide 460.200 (CPG)(2002), which was then in effect.[2]. During the FDA inspection, investigators observed that your firm does not receive valid prescriptions for individually-identified patients for a portion of the drug products you produce. Based on this factor alone, those drugs were not entitled to the statutory exemptions for compounded drugs described in section 503A of the FDCA and did not qualify for the agency’s exercise of enforcement discretion set forth in the CPG.[3] ... Since FDA inspected your facility, Congress enacted and the President signed into law the Compounding Quality Act (CQA)[4], which amended FDCA section 503A by eliminating the advertising restrictions that had been the basis for conflicting judicial decisions. The CQA otherwise left section 503A intact, and so clarified that the remainder of section 503A, including the requirement of valid prescriptions for individually-identified patients, is applicable in every federal judicial circuit. Accordingly, the drugs you compound without valid prescriptions for individually identified patients are not entitled to the exemptions in section 503A.[5] ... Because the drug products that you manufacture and distribute without valid prescriptions for individually-identified patients are not the subject of approved applications, they are unapproved new drugs and misbranded drugs in violation of sections 505(a) and 502(f)(1) [21 U.S.C. §§ 355(a) and 352(f)(1)] of the FDCA, respectively. ... Unapproved New Drug Products
You do not have any FDA-approved applications on file for the drug products for which you have not obtained valid prescriptions for individually-identified patients.[7] Under sections 301(d) and 505(a) of the FDCA [21 U.S.C. §§ 331(d) and 355(a)], a new drug may not be introduced into or delivered for introduction into interstate commerce unless an application approved by FDA under section 505 of the FDCA [21 U.S.C. § 355] is in effect for the drug. Your marketing of these products, or other applicable products, without an approved application violates these provisions of the FDCA."
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WHAT THIS BASICALLY SAYS IS:
Compounding pharmacies who are not registered as outsourcing facilities:
- CANNOT ship drugs to physician offices or hospitals for "office use" (not even in "limited quantities")
- CANNOT receive a manifest of patients to whom these compounded drugs were dispensed to by physicians AFTER THE DRUGS HAD ALREADY BEEN DISPENSED.
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Now, will individual state board's of pharmacy and each state's Department of Health Bureau of Enforcement help the FDA enforce the law against rogue compounding pharmacies? That is the big question.
Kenneth Woliner, M.D., A.B.F.M.
www.holisticfamilymed.com