Inspections, Compliance, Enforcement, and Criminal Investigations

Pensacola Apothecary, Inc. DBA Everwell Specialty Pharmacy 6/28/17



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Office of Pharmaceutical Quality Operations, Division II
4040 N. Central Expressway, Suite 300
Dallas, Texas 75204 



June 28, 2017
CMS Case # 524550                                                                               

Christopher M. Schulte, Owner
Pensacola Apothecary, Inc. dba Everwell Specialty Pharmacy
6506 N Davis Highway
Pensacola, Florida 32504-6957
Dear Mr. Schulte:
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.
A.    Compounded Drug Products Under the FDCA
Section 503A of the FDCA describes the conditions under which human drug products compounded by a licensed pharmacist in a State licensed pharmacy or a Federal facility, or a licensed physician, qualify for exemptions from three sections of the FDCA: compliance with current good manufacturing practices (CGMP) (section 501(a)(2)(B)); labeling with adequate directions for use (section 502(f)(1)); and FDA approval prior to marketing (section 505) [21 U.S.C. §§ 351(a)(2)(B), 352(f)(1) and 355(a)].[1] Receipt of valid prescriptions for individually-identified patients is one of the conditions for the exemptions under section 503A. 
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.
B.    Failure to Meet the Conditions of Section 503A
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.”
Specific violations are described below. 
C.    Violations of the FDCA
Adulterated 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: 
  1. 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)).
  1. Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(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.
Misbranded Drug Products
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.
D.   Corrective Actions
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] 
In addition to the issues discussed above, you should note that CGMP requires the implementation of quality oversight and controls over the manufacture of drugs, including the safety of raw materials, materials used in drug manufacturing, and finished drug products. See section 501 of the FDCA.  If you choose to contract with a laboratory to perform some functions required by CGMP, it is essential that you select a qualified contractor and that you maintain sufficient oversight of the contractor’s operations to ensure that it is fully CGMP compliant.  Regardless of whether you rely on a contract facility, you are responsible for assuring that drugs you introduce into interstate commerce are neither adulterated nor misbranded.  [See 21 CFR 210.1(b), 21 CFR 200.10(b)].
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. 
E.    Conclusion
The violations cited in this letter are not intended to be an all-inclusive statement of violations at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. 
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  
If you have questions regarding the contents of this letter, please contact John W. Diehl at (214) 253-5288.
Monica R. Maxwell
Acting Program Division Director
Office of Pharmaceutical Quality Operations, Division II
Christopher Ferguson, Chief
Florida Department of Health
Investigative Services Unit
4052 Bald Cypress Way, Bin C-70
Tallahassee, Florida 32399

[1] We remind you that there are conditions other than those discussed in this letter that must be satisfied to qualify for the exemptions in section 503A of the FDCA.
[2] Your ineligible drug products are not exempted from the requirements of section 502(f)(1) of the FDCA by regulations issued by the FDA (see, e.g., 21 CFR 201.115).
[3] In this letter we do not address whether your proposed corrective actions would resolve the CGMP violations noted above.

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