Inspections, Compliance, Enforcement, and Criminal Investigations

TSDR Pharmacy Inc. dba brandMD Skin Care 11/9/17

 

  

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Division of Pharmaceutical Quality Operations IV
19701 Fairchild, Irvine, CA 92612-2506
Telephone: 949-608-2900
Fax: 949-608-4417 

 
 

 

WARNING LETTER
 
 
VIA SIGNATURE CONFIRMED DELIVERY
 
 
November 9, 2017
 
Samuel D. Raoof
President and Chief Executive Officer
TSDR Pharmacy, Inc. DBA brandMD Skin Care
20660 Nordhoff Street, Unit C
Chatsworth, California 91311-6114
 
Dear Mr. Raoof:
 
From March 20, 2017, to March 28, 2017, a U.S. Food and Drug Administration (FDA) investigator inspected your facility, TSDR Pharmacy, Inc. DBA brandMD Skin Care, located at 20660 Nordhoff Street, Unit C, in Chatsworth, California 91311-6114. 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. Additionally, the investigator noted serious deficiencies in your practices for producing non-sterile drug products, which put patients at risk.  
 
FDA issued a Form FDA 483 to your firm on March 28, 2017. FDA acknowledges receipt of your facility’s response, dated April 11, 2017. 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 investigator noted that drug products produced by your firm failed to meet the conditions of section 503A. Specifically, 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 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 FDA investigator noted that drug products were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA.  For example, the investigator observed a strip of black oily residue contaminating the (b)(4) your (b)(4) after you claimed it had purportedly been cleaned. You were able to wipe out part of the residue with your fingers in the presence of our investigator, and you admitted your pharmacy does not have cleaning procedures.
 
Furthermore, 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 failed to establish and follow adequate written procedures for cleaning and maintenance of equipment [21 CFR 211.67(b)].
  2. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity [21 CFR 211.160(b)].
  3. Your firm failed to establish a quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products [21 CFR 211.22(a)].
  4. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess [21 CFR 211.100(a)].
  5. Your firm failed to routinely calibrate, inspect, or check according to a written program designed to assure proper performance and to maintain adequate written records of calibration checks and inspections of automatic, mechanical, electronic equipment, or other types of equipment, including computers, used in the manufacture, processing, packing, and holding of a drug product [21 CFR 211.68(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 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.
 
Unapproved New Drug Products
 
You do not have any FDA-approved applications on file for the ineligible drug products that you compounded.[2] Under sections 505(a) and 301(d) of the FDCA [21 U.S.C. § 331(d)], 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 is in effect for the drug. Marketing of these products, or other applicable products, without an approved application violates these provisions of the FDCA.
 
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.[3] Accordingly, these ineligible drug products are misbranded under section 502(f)(1) of the FDCA. The introduction or delivery for introduction into interstate commerce of these products therefore violates section 301(a) of the FDCA.  It is also 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 response to the Form FDA 483 dated April 11, 2017.
 
Regarding the insanitary condition observed during the inspection in the Form FDA 483, your response did not adequately address the contamination of the (b)(4). You did not provide any explanation for the presence of the oily black residue in the (b)(4) and you only stated during the inspection that the equipment would be cleaned again before compounding another drug product.
 
Please be aware that section 501(a)(2)(A) of the FDCA concerning insanitary conditions applies regardless of whether drug products you compound meet the conditions of section 503A, including the condition on receipt of a prescription for an identified individual patient prior to compounding and distributing drug products. 
 
In addition, regarding issues related to the conditions of section 503A of the FDCA, your response regarding your firm’s practice of producing and distributing drug products which are not pursuant to receipt of a prescription for an identified individual patient (i.e., “office stock”) is not adequate. Section 503A does not provide for distributing a compounded drug product before receiving a valid prescription order for an identified individual patient.  We recognize that some state boards of pharmacy may authorize the writing of prescriptions that do not include individual patient names. Such prescriptions, however, do not meet the requirement of a patient-specific prescription in section 503A. Lastly, you write “The DQSA only confers cGMP jurisdiction to the FDA for sterile compounding activities, but not for non-sterile compounding, per FDCA § 503B(d)(4)&(5).” We note that section 503B of the FDCA concerns outsourcing facilities, not state-licensed pharmacies seeking to qualify for the exemptions of section 503A, and this section does not limit FDA’s authority to enforce CGMP requirements against state-licensed pharmacies distributing compounded drugs that do not meet the conditions in section 503A. 
 
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.[4] 
 
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 produce are neither adulterated nor misbranded.  [See 21 CFR 210.1(b), 21 CFR 200.10(b)].
 
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 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 (516046). Please address your written response to:
 
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
U.S. Food & Drug Administration
19701 Fairchild
Irvine, California 92612
 
If you have questions regarding any issues in this letter, please contact Mariza Jafary via email at Mariza.Jafary@fda.hhs.gov or by telephone at 949-608-2977 and reference unique identifier 516046.
 
Sincerely,
/S/ 
Kelli F. Dobilas
Acting Director, Division of Pharmaceutical Quality Operations IV


[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] The specific products made by your firm are drugs within the meaning of section 201(g) of the Act, [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. Further, they are “new drugs” within the meaning of section 201(p) [21 U.S.C. 321(p)] of the FDCA because they are not generally recognized as safe and effective for their labeled uses. 
[3]   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).
[4] In this letter, we do not address whether your proposed corrective actions would resolve the CGMP violations noted above.

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