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July 30, 2019

Case # 579286

WARNING LETTER

VIA UPS EXPRESS

Raymond L. Solano III, General Manager
Prescription Dispensing Laboratories, Inc. dba PD Labs
101 Commercial Parkway
Cedar Park, Texas 78613

Mr. Solano:

From May 7, 2018, to May 11, 2018, a U.S. Food and Drug Administration (FDA) investigator inspected your facility, Prescription Dispensing Laboratories, Inc., dba PD Labs located at 101 Commercial Parkway, Cedar Park, Texas 78613. 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.

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 practice (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.

In addition, for a compounded drug product to qualify for the exemptions under section 503A, bulk drug substances used to compound it must: (I) comply with the standards of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph, if a monograph exists, and the USP chapter on pharmacy compounding; (II) if such a monograph does not exist, be components of drugs approved by the Secretary; or (III) if such a monograph does not exist and the drug substance is not a component of a drug approved by the Secretary, appear on a list developed by the Secretary through regulation (“503A bulks list”) (section 503A(b)(1)(A)(i) of the FDCA).

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, your firm compounded drug products using alpha glycerophophorylcholine (alpha-GPC), BPC-157 acetate, nicotinamide riboside chloride, panax ginseng (RG3), theacrine and thymus. Drug products compounded using these products are not eligible for the exemptions provided by section 503A(a), because they are not the subject of an applicable USP or NF monograph, are not a component of an FDA-approved human drug, and do not appear on the 503A bulks list.2

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

Unapproved New Drug Products

You do not have any FDA-approved applications on file for the ineligible drug products that you compounded.3 Under sections 505(a) and 301(d) of the FDCA [21 U.S.C. §§ 355(a) and 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.4 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

Regarding observations related to the conditions of Section 503A, the following corrective actions appears adequate: during the inspection and in your May 11, 2018, correspondence, you agreed to cease compounding drug products containing theacrine and thymus due to “lack of a readily available USP monograph or supporting documentation required for 503A pharmacies.”

However, you also stated you would continue to compound alpha-GPC, BPC-157 acetate, nicotinamide riboside chloride and RG3 and provide the investigator with the USP monograph and approved drug listing or additional documentation for these drugs. As explained above, drug products compounded using these bulk drug substances are not eligible for the exemptions by section 503A(a), because they are not the subject of applicable USP or NF monographs, are not components of FDA-approved human drugs, and do not appear on the 503A bulks list.

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.

Furthermore, during the inspection, the FDA investigator noted that your firm compounded drug products using colloidal silver. We note that drug products compounded using colloidal silver are not eligible for the exemptions by section 503A(a) because this bulk drug substance is not the subject of an applicable USP or NF monograph, is not a component of an FDA-approved human drug, and does not appear on the 503A bulks list. In addition, FDA has noted in the past that “[t]here are serious and complicating aspects to many of the diseases…silver ingredients purport to treat or prevent.” See 21 CFR 310.548. Please be advised that FDA has received numerous reports of serious adverse events associated with colloidal silver and is unaware of any adequate and well-controlled studies to support the use of this drug for any disease or condition.

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 fifteen (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 Case # 579286.

Please electronically submit your reply on company letterhead to Dayna I. Martinez, Compliance Officer, at [email protected]. In addition, please submit a signed copy of your response to [email protected] and [email protected].

If you have questions regarding the contents of this letter, you may contact Ms. Dayna I. Martínez, Compliance Officer via (787) 729-8608 or [email protected].

Sincerely,
/S/

Monica R. Maxwell
Program Division Director
Office of Pharmaceutical Quality Operations,
Division II

CC:
Allison Vordenbaumen Benz, R.Ph., M.S.
Executive Director/Secretary
Texas State Board of Pharmacy
333 Guadalupe, Suite #3-500
Austin,Texas 78701
 

_______________________

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 On June 9, 2016, FDA issued a final guidance titled, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act. This guidance describes FDA’s interim regulatory policy for State-licensed pharmacies, Federal facilities, and licensed physicians that compound human drug products using bulk drug substances that do not otherwise meet the conditions of section 503A(b)(1)(A)(i) while the 503A bulks list is being developed. Specifically, the guidance sets out the conditions under which FDA does not intend to take action against a State-licensed pharmacy, Federal facility, or licensed physician for compounding a drug product using a bulk drug substance that is not the subject of an applicable USP or NF monograph or a component of an FDA approved drug, until the substance is identified in a final rule as included or not included on the 503A bulks list. These conditions include that the substance may be eligible for inclusion on the 503A bulks list, was nominated with adequate support for FDA to evaluate it, and has not been identified by FDA as a substance that appears to present significant safety risks pending further evaluation. Alpha-GPC, BPC-157 acetate, nicotinamide riboside chloride, RG3, theacrine, and thymus were not nominated for inclusion on the 503A bulks list. For additional information, see the guidance at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM469120.pdf.

3 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.

4 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).