Inspections, Compliance, Enforcement, and Criminal Investigations

Arnold Professional Pharmacy 4/7/17

 

  

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Baltimore District Office
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Tel:      (410) 779-5455
Fax:     (410) 779-5707 

 

                                                                                               
 
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
WARNING LETTER
CMS #521908
April 7, 2017
 
Neil P. McGarvey, Pharm.D., Co-Owner
Arnold Professional Pharmacy
1460 Ritchie Highway, Suite 103
Arnold, MD 21012
 
Dear Dr. McGarvey:
 
From May 2, 2016, to May 6, 2016, U.S. Food and Drug Administration (FDA) investigators inspected your facility, Arnold Professional Pharmacy, located at 1460 Ritchie Highway, Suite 103, Arnold, MD 21012. During the inspection, the investigators 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.  In addition, the investigators noted serious deficiencies in your practices for producing drug products, which put patients at risk.  
 
FDA issued a Form FDA 483 to your firm on May 6, 2016.  FDA acknowledges receipt of your facility’s response, on May 27, 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. 
 
B.     Failure to Meet the Conditions of Section 503A
 
During the inspection, the FDA investigators noted that drug products produced by your firm failed to meet the conditions of section 503A.  For example, the investigators 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 in that section 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 investigators observed a significant CGMP violation at your facility, causing the ineligible drug products to be adulterated within the meaning of section 501(a)(2)(B) of the FDCA.  Specifically, your firm’s testing and release of drug products for distribution do not include appropriate laboratory determination of satisfactory conformance to final specifications and identity and strength of each active ingredient prior to release [21 CFR 211.165(a)].
 
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 a 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 the 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 responses to the Form FDA 483. Your response states that your firm “customarily sends out one randomly sampled compound per month for testing.” This response is deficient because it suggests that not all produced batches of non-patient specific compounded drug products are tested for strength before release.  
 
As explained above, receipt of valid prescriptions for individually-identified patients is a condition of section 503A, which your firm failed to meet for a portion of the drug products you produced. Should you continue to 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.
 
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 your drugs 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.  A third party consultant with relevant drug manufacturing expertise should assist you in conducting this comprehensive evaluation.
 
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 (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you do not believe that the products discussed above are in violation of the FDCA, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the correction.
 
Your written notification should refer to the Warning Letter Number above (CMS #521908). Please address your reply to:
 
Cherlita Honeycutt
Compliance Officer
Food and Drug Administration
Baltimore District
6000 Metro Drive, Suite 101
Baltimore, MD 21215
 
 
If you have questions regarding the contents of this letter, please contact Cherlita Honeycutt via email at Cherlita.Honeycutt@fda.hhs.gov or by phone at 410-779-5412.
 
 
Sincerely,
/S/           
Evelyn Bonnin
Director
Baltimore District
 
Cc: Jeremy Cundiff, Pharm. D., Co-Owner
Arnold Professional Pharmacy
1460 Ritchie Highway, Suite 103
Arnold, MD 21012
 
Cc: Maryland Department of Health
Cc: Maryland Board of Pharmacy


[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).

 

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