Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pensacola-apothecary-inc-dba-everwell-specialty-pharmacy-524550-06282017
Timestamp: 2019-06-26 11:42:13
Document Index: 464932329

Matched Legal Cases: ['§ 353', '§ 321', '§ 360', 'arts 210', '§ 360', 'art 530', 'arts 210', '§ 331', '§ 331']

Pensacola Apothecary, Inc. DBA Everwell Specialty Pharmacy - 524550 - 06/28/2017 | FDA
Pensacola Apothecary, Inc. DBA Everwell Specialty Pharmacy - 524550 - 06/28/2017
Pensacola Apothecary, Inc. DBA Everwell Specialty Pharmacy MARCS-CMS 524550 — 28/06/2017
Pensacola Apothecary, Inc. DBA Everwell Specialty Pharmacy
CMS Case # 524550
Christopher M. Schulte, Owner
6506 N Davis Highway
Pensacola, Florida 32504-6957
From August 22, 2016, to August 31, 2016, a U.S. Food and Drug Administration (FDA) investigator inspected your facility, Pensacola Apothecary, Inc., dba Everwell Specialty Pharmacy, 6506 N Davis Highway, Pensacola, Florida 32504-6957. During the inspection, the investigator noted that drug products you produced failed to meet the conditions of section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. § 353a] for exemption from certain provisions of the FDCA.
FDA issued a Form FDA 483 to your firm on August 31, 2016. FDA acknowledges receipt of your facility’s response, dated September 19, 2016. FDA also acknowledges the statement in your response letter indicating that “Everwell Specialty Pharmacy has ceased compounding any non-sterile medications for office-use as of August 23, 2016." Based on this inspection, it appears that you produced drug products that violate the FDCA.
Although, section 503A of the FD&C Act provides certain statutory exemptions for compounded human drugs, this section does not provide exemptions for drugs compounded for animal use. Conversely, the compounding of an animal drug from bulk drug substances results in a new animal drug .The term “new animal drug” is defined by section 201(v) of the FD&C Act [21 U.S.C. § 321(v)], as an animal drug that is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.
A new animal drug must be the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, or 572 of the FD&C Act [21 U.S.C. §§ 360b, 360ccc, and 360ccc-1]. Further, all animal drugs are required to, among other things, be made in accordance with current good manufacturing practice (CGMP) requirements (section 501(a)(2)(B)) of the FD&C Act and 21 CFR parts 210 and 211) and have adequate directions for use (section 502(f)(1) of the FD&C Act).
A limited exception from the requirements for approval, labeling with adequate directions for use, and manufacturing in accordance with CGMP is provided by the extralabel use provisions of sections 512(a)(4) and (5) of the FD&C Act [21 U.S.C. §§ 360b(a)(4) and (5)] (AMDUCA). Compounding from approved, finished human or animal drugs is considered an extralabel use of approved drugs and is permitted so long as it complies with the conditions set out in the extralabel use provisions of the FD&C Act and FDA’s extralabel use regulations at 21 CFR part 530. Among other things, these regulations specify that nothing in the regulations should be construed as permitting compounding animal drugs from bulk drug substances.
Because FDA recognizes that drugs compounded from bulk drug substances may be a necessary and appropriate veterinary treatment option in limited circumstances, in May 2015, FDA proposed draft guidance for industry (GFI #230) “Compounding Animal Drugs from Bulk Drug Substances.” The purpose of the proposed draft is to provide clarity regarding the conditions under which FDA would generally not intend to take action for certain violations of the law when an animal drug is compounded from a bulk drug substance.
During the inspection, the FDA investigator noted that drug products produced by your firm failed to meet the conditions of section 503A. For example, the investigator noted that your firm did not receive valid prescriptions for individually-identified patients for a portion of the drug products you produced.
Therefore, you compounded drug products that do not meet the conditions of section 503A and are not eligible for the exemptions from the FDA approval requirement of section 505 of the FDCA, the requirement under section 502(f)(1) of the FDCA that labeling bear adequate directions for use, and the requirement of compliance with CGMP under section 501(a)(2)(B) of the FDCA. In the remainder of this letter, we refer to your drug products that do not qualify for exemptions under section 503A as the “ineligible drug products.”
The manufacture of the ineligible drug products is subject to FDA’s CGMP regulations, Title 21, Code of Federal Regulations (CFR), parts 210 and 211. The FDA investigator observed significant CGMP violations at your facility, causing the ineligible drug products to be adulterated within the meaning of section 501(a)(2)(B) of the FDCA. The violations included, for example:
Your firm does not have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).
Under section 301(a) of the FDCA [21 U.S.C. § 331(a)], the introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act. Further, it is a prohibited act under section 301(k) of the FDCA [21 U.S.C. § 331(k)] to do any act with respect to any human or animal drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being adulterated.
The ineligible drug products you compounded are intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use these products safely for their intended uses. Consequently, their labeling fails to bear adequate directions for their intended uses.[2] Accordingly, these ineligible drug products are misbranded under section 502(f)(1) of the FDCA. It is a prohibited act under section 301(k) of the FDCA to do any act with respect to a drug, if such act is done while any human or animal drug is held for sale after shipment in interstate commerce and results in the drug being misbranded.
We have reviewed your firm’s response to the Form FDA 483, dated September 19, 2016. Regarding issues related to the conditions of section 503A of the FDCA, the following corrective action appears adequate: In your firm’s response to the Form FDA 483, you state that “Everwell Specialty Pharmacy has ceased compounding any non-sterile medications for office-use as of August 23, 2016."
Should you compound and distribute drug products that do not meet the conditions of section 503A, the compounding and distribution of such drugs would be subject to the new drug approval requirement, the requirement to label drug products with adequate directions for use, and the drug CGMP regulations. Before doing so, you must comply with the requirements of section 505 and 502(f)(1) and fully implement corrections that meet the minimum requirements of the CGMP regulations.[3]
FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance materials, and systems for human and animal drugs.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Furthermore, please advise this office what actions you will take to address product that you have already distributed. Additionally, if another firm manufactures the products identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the products is not the manufacturer, please include the name of your supplier in addition to the manufacturer. Your written notification should refer to the Warning Letter Number above (CMS Case # 524550).
Please address your reply to John W. Diehl, Acting Director, Compliance Branch at the FDA address provided on the first page of this letter. In addition, please submit a signed copy of your response to john.diehl@fda.hhs.gov.
If you have questions regarding the contents of this letter, please contact John W. Diehl at (214) 253-5288.
4052 Bald Cypress Way, Bin C-70