Full opinion text
OPINION AND ORDER ROSEN, United States Magistrate Judge. I. INTRODUCTION Presently before the court is the motion by Wedgewood Village Pharmacy, Inc., d/b/a Wedgewood Pharmacy (“Wedge-wood”), to quash a warrant for administrative inspection issued ex parte by this court to the United States Food and Drug Administration (“FDA”) on March 10, 2003, pursuant to the Federal Food, Drug, Cosmetic Act (“FDCA”) 21 U.S.C. § 301, et seq. For the reasons discussed below, Wedgewood’s motion to quash shall be denied. II. FACTUAL AND PROCEDURAL BACKGROUND A. The March, 2003 Warrant Application Wedgewood is a New Jersey licensed pharmacy that has operated in good standing for twenty-two years. (See Wedge-wood “Motion to Quash Warrant For Inspection Under the Federal Food, Drug, and Cosmetic Act” (hereinafter “Wedge-wood Br.”) at 7; Wedgewood Reply at 4). Located in Sewell, New Jersey, Wedge-wood is owned and operated by George Malmberg, a pharmacist who holds a current and valid New Jersey license. (Id.). Wedgewood specializes in compounding, selling, and dispensing pharmaceuticals for human and animal application which it dispenses nationwide. (See Wedgewood Br. at 7). On March 10, 2003, an investigator for the New Jersey District Office of the FDA, duly designated, applied to this court for an administrative inspection warrant for Wedgewood’s Sewell, New Jersey, facility. (See Application for Inspection Warrant (‘Warrant App.”), FDA Opp. Br., Ex. A). By its terms, the FDA warrant application, comprising eighteen pages, was brought pursuant to 21 U.S.C. § 374(a). The application detailed the legal and factual basis for the FDA’s request. As a factual basis, the warrant application first directed the court to a recent development; the United States Drug Enforcement Agency (“DEA”) had requested assistance in conducting an “inter-agency” on-site investigation at Wedgewood. (Warrant App., ¶ 3). This inter-agency effort related to “matters currently under investigation,” most notably Wedgewood’s failure to report the theft of controlled drug substances to the DEA, required under 21 C.F.R. 1301.76(b). The theft of the drug substances may have resulted in overdoses by high school students in October 2001. (Id. at ¶ 2). Relying on the FDCA, the FDA identified several anomalies in Wedgewood’s pharmacy practice that the FDA believed supported its position that Wedgewood had violated the Act and, thus, that supported an inspection under Section 374. The warrant application referenced paragraphs six to eleven as a factual basis for the suspected violations. (See id. at ¶¶ 12-13). Paragraphs six through eight informed the court of Wedgewood’s practice of producing Poison Ivy Extract in large quantity, without prescriptions for specific patients, during the period between January and March 1998. This practice was discovered in the inspection completed by the New Jersey State Department of Law and Public Safety, Division of Consumer Affairs, Enforcement Bureau, conducted by Investigator Wayne Nastase on February 27 through March 4, 1998. (Id. at ¶ 7). The FDA had attempted an inspection without a warrant on this issue on February 23, 1998, but had been turned away by owner and CEO of Wedgewood, George J. Malmberg. (Id., ¶ 6). Following Nastase’s inspection, and subsequent sharing of information with the FDA, the FDA and Wedgewood representatives entered discussions. The discussions resulted in Wedgewood’s acknowledging that it needed to obtain a Biologic License Application for the product, pursuant to 42 U.S.C. 262(a), (c), to recall the product already distributed, and to cooperate with an FDA inspection regarding the Poison Ivy Extract. {Id., ¶ 8). During the inspection, Mr. Malmberg “verbally promised to cease production and distribution of the Poison Ivy Extract.” {Id.). Paragraphs nine to eleven described information gleaned from a February 3, 2003 DEA Report of Investigation, which informed the FDA, inter alia, of the following events and practices by Wedgewood: (1) the receipt of an encapsulation machine in May 2002; (2) evidence that Wedge-wood was compounding drugs that are “copies of FDA-approved, commercially available products such as diazepam tablets, sildenafil tablets, and several veterinary drug products;” (3) the purchase of 11.5 kilograms of diazepam in the six-month period between August 2001 and February 2002; (4) the purchase of 17 kilograms of boldenone undecylenate in the six-month period between January and July 2002; and (5) the purchase of 30 kilograms of stanozolol in the sixteen-month period between July 2001 and November 2002. (Warrant App., FDA Opp. Br., Ex. A, ¶ 9). The FDA warrant application explained that, for example, the dia-zepam bulk drug substance purchased by Wedgewood was enough to manufacture over one million lOmg tablets or capsules in the six-month period. {Id., ¶ 10). The FDA warrant application noted that such production is atypical of pharmacy compounding and rather more akin to a commercial drug manufacturer’s production. {Id.). The warrant application further indicated that on February 20, 2003, the FDA was informed by New Jersey State Investigator Wayne Nastase that “Wedgewood had a commercial scale mixer and receives excipient materials (i.e. ingredients for drug products that are not the active ingredients) in bags exceeding 50 pounds.” {Id. at ¶ 11). Nastase also informed the FDA that ‘Wedgewood Pharmacy routinely manufactures veterinary drug products in bulk, prior to receipt of specific veterinarian prescribing orders.” (Id.). Finally, Nastase reported to the FDA that Wedge-wood was manufacturing versions of silde-nafil, the active ingredient in Viagra, in the form of a lozenge, and that testing completed on those lozenges in 1999 indicated that they were “sub-potent.” (Id.). Based on this information, the FDA requested that this court sign the “preemptive inspection warrant” to give the FDA “access to production and distribution records to determine the extent to which this firm’s activities are consistent with those of a drug manufacturer rather than a retail pharmacy, and to evaluate the extent of violations of the Act, including the new drug and new animal drug approval requirements, and the Act’s adulteration provisions.” (Warrant App., ¶ 20). The warrant application further described in detail the purpose for the inspection: (A) determine whether Wedgewood Pharmacy is compounding human drugs that are copies of commercially available FDA-approved products; (B) identify the original manufacturers of bulk drug substances used by Wedgewood Pharmacy to compound human drug products, and determine whether these ingredients have been manufactured in FDA-registered facilities and meet official compendial requirements; (C) determine whether drugs for veterinary use are being compounded in conformance with the AMDUCA implementing regulations in 21 CFR Part 530; (D) determine the frequency and volumes of human drug production batches, the frequency and volumes of shipments, and the number and types of consignees, e.g., physicians, clinics, hospitals, or other state licensed pharmacies, who are receiving Wedgewood Pharmacy’s compounded prescription drugs, in order to determine whether the compounding is being done for other parties for resale; (E) determine, for those products found to be copies of FDA-approved, commercially available products, whether Wedgewood Pharmacy has documentation of individual patients’ medical need for particular variations; (F) determine whether the firm has adequate controls in place to assure that its injectable and implantable drug products are sterile; (G) determine whether valid prescriptions for identified individual patients are received prior to dispensing, for each compounded human drug product that is dispensed; (G) determine whether human drug products are being compounded in anticipation of receiving prescriptions, including quantities, and how such amounts compare to the amounts compounded after receiving valid prescriptions; (I) determine whether Wedgewood Pharmacy uses commercial scale manufacturing equipment to compound drug products; and (J) determine whether Wedgewood is compounding any human drug products that have been withdrawn or removed from the market for safety reasons. (Warrant App., ¶ 21). The FDA then provided the court with a detailed listing of the information they would target in the inspection: “(1) • • ■ Wedgewood Pharmacy facilities, and all things therein, including equipment, finished and unfinished materials, containers, labeling, records (including electronic and computer records), files, papers, processes, controls, and facilities, bearing on whether prescription drugs intended for human use and prescription and non-prescription animal drugs which are adulterated or misbranded within the meaning of the Act, or which may not be manufactured, introduced into interstate commerce, sold, or offered for sale by reason of any provision of the Act, have been or are being manufactured, processed, packed, transported, or held in such facilities, or otherwise bearing on violation of the Act; (2) to collect samples as deemed necessary by FDA; and (3) to take photographs as deemed necessary by FDA.” (Id. at ¶ 24). The warrant itself included the name of the establishment to be inspected and a description of the manner and items subject to inspection. (See Warrant, Wedge-wood Br., Ex. 4). The warrant further provided that the inspection begin “as soon as practicable after the issuance of this warrant and will be completed with reasonable promptness.” (Id.). After careful review and consideration, this court signed the warrant on March 10, 2003. B. The Inspection Two FDA investigators, accompanied by a Deputy U.S. Marshal, executed the inspection warrant on March 12, 2003. (FDA Opp. Br. at 3). Wedgewood asserts that the FDA inspectors were accompanied by approximately twelve DEA agents and other U.S. Marshals. (See Wedge-wood Br. at 2). Malmberg, on advice of counsel, informed the FDA agents that he would not cooperate in the execution of the warrant. (Id. at 9). A marshal indicated to Malmberg that if he did not comply, he would be taken into custody immediately. (Id,-)- Malmberg acquiesced under the threat of detainment and permitted the inspection to proceed. However, Malm-berg attached a statement of protest to all records and other information collected by the FDA. One of the statements provided that: “I am turning over the records attached to this statement only because of the actually stated threat by the United States Marshall [sic] that if I don’t, I will be immediately taken into custody and all the pharmacy’s computers, records and more will be immediately seized and removed from the pharmacy by the United States Marshall [sic].” (Id., Ex. 10). Another such statement included reference to “Department of Justice Counsel, Jerry Kell[’s]” advice to the same effect. (Id., Ex. 11). The inspection of Wedgewood under the warrant continued on March 13 and 14, and FDA inspectors indicated to Wedge-wood representatives that the FDA planned to continue the inspection on March 18, 2003. (See Wedgewood Br. at 2, n. 1). Wedgewood filed the instant motion to quash the FDA warrant on March 17, 2003. C. Motion to Quash In support of its motion, Wedgewood asserts as fact the following information about itself, claiming that Wedgewood: • specializes in compounding drugs on the order of a licensed practitioner, [either physician or veterinarian]; • specializes in traditional compounding of drugs for humans and pets (companion animals) and equine animals (e.g., race horses); • does not compound for livestock (feed animals) or feed producers, and, therefore, presents no potential that its drug compounds will leach into the food chain; • does not compound a drug when a suitable, commercially-manufactured drug is available; and • compounds “extemporaneously” [meaning] “upon the receipt of the physician’s order or from a permissible inventory based on historical ordering patterns.” (Id. at 4-5, n. 2-3 (emphasis in original)). Wedgewood maintains that these few facts are “likely uncontested” (Wedgewood Reply at 4); yet, these are precisely the facts that the administrative warrant attacks. Wedgewood supplies no documentary evidence supporting these assertions, relying only upon an affidavit by Mr. Malmberg which attests to the accuracy of the information contained within Wedgewood’s motion and reply. The essence of Wedgewood’s motion is its belief that the FDA’s application for a warrant is inappropriate because the FDA lacks jurisdiction over state licensed pharmacies under any circumstance. For example, Wedgewood maintains that “[t]here was no justification for applying for the Warrants ex parte, other than to prevent Wedgewood from appearing and informing the Court of the FDA’s absolute lack of jurisdiction, because Wedgewood is a state-licensed pharmacy.” (Wedgewood Br. at 3). In its reply, Wedgewood outlines its position succinctly: “Congress exempted state-licensed pharmacies from registration and inspection by the FDA; this was a fact well known to the FDA and Director Axelrad at the time the FDA applied for and commenced execution on the ex parte Warrant; compounding, a pharmacy-based activity, is defined by the states and regulated only by state pharmacy boards, not the FDA; the FDA regulates manufacturing by manufacturers; under the explicit language of the Food, Drug, and Cosmetic Act (“FDCA”), even manufacturing performed by pharmacies is exempted from the FDCA and FDA oversight; ... and compounds, by statute and case law, are not — and are incapable of being — ‘new drugs.’” (Wedgewood Reply at 3-4). Despite this and other unequivocal statements in its briefs that the FDA lacks any jurisdiction under any circumstances over pharmacies, during oral argument, counsel for Wedgewood conceded, though grudgingly, that the FDCA contains a limited statutory exemption for pharmacies and that if Wedgewood does not meet the elements of that statutory exemption, then it is subject to FDA regulation under the FDCA. (See Transcript of Oral Argument conducted before this court on May 22, 2003 at T38:19-39:4). Wedgewood also concedes that the government generally has the right to seek a warrant ex parte. (Wedgewood Reply at 22). However, Wedgewood maintains that because the FDA knew that its application was not grounded in the law, the FDA acted in bad faith and so vitiated the ex parte administrative warrant. (Id. at 23-25 and Ex. 1). Finally, Wedgewood contends that the warrant was not based on probable cause. (See, e.g., Wedgewood Br. at 13-17). III. DISCUSSION A. Standard for Quashing Administrative Warrant Under the FDCA The Supreme Court has long held that a warrant is required for a search to be considered reasonable under the Fourth Amendment, whether conducted in a home or a commercial establishment. See, e.g., See v. City of Seattle, 387 U.S. 541, 545, 87 S.Ct. 1737, 18 L.Ed.2d 943 (1967). “An owner or operator of a business thus has an expectation of privacy in commercial property, which society is prepared to consider to be reasonable.” New York v. Burger, 482 U.S. 691, 699, 107 S.Ct. 2636, 96 L.Ed.2d 601 (1987) (internal citation omitted). Society’s tolerance for searches of business establishments exists on a continuum. “An expectation of privacy in commercial premises ... is different from, and indeed less than, a similar expectation in an individual’s home.” Id. at 700, 107 S.Ct. 2636. In the business context, the Court has relaxed the warrant clause of the Fourth Amendment to account for the exigencies of administrative inspections “designed to enforce regulatory statutes.” Id. at 700, 107 S.Ct. 2636. The Court has gone so far as to hold that “[cjertain industries have such a history of government oversight that no reasonable expectation of privacy ... could exist for a proprietor over the stock of such an enterprise.” Id. (quoting Marshall v. Barlow’s, Inc., 436 U.S. 307, 313, 98 S.Ct. 1816, 56 L.Ed.2d 305 (1978) (internal citations omitted)). “ “When a dealer chooses to engage in [a] pervasively regulated business and to accept a federal license, he does so with the knowledge that his business records, [and stock] will be subject to effective inspection.’ ” Id. (quoting United States v. Biswell, 406 U.S. 311, 316, 92 S.Ct. 1593, 32 L.Ed.2d 87 (1972)). So significant is the necessity for effective inspection that in such “pervasively regulated” industries, the Court has dispensed with the need for a warrant at all. United States v. Biswell, 406 U.S. 311, 316-17, 92 S.Ct. 1593, 32 L.Ed.2d 87 (1972) (permitting warrantless inspection in the gun selling industry); see also New York v. Burger, 482 U.S. 691, 703-704, 107 S.Ct. 2636, 96 L.Ed.2d 601 (1987) (same in vehicle-dismantling and automobile junkyard industry); Donovan v. Dewey, 452 U.S. 594, 602-05, 101 S.Ct. 2534, 69 L.Ed.2d 262 (1981) (same in coal mines); Colonnade Catering Corp. v. United States, 397 U.S. 72, 76-77, 90 S.Ct. 774, 25 L.Ed.2d 60 (1970) (same in the liquor industry). The Court explained: “The greater latitude to conduct warrantless inspections of commercial property reflects the fact that the expectation of privacy that the owner of commercial property enjoys in such property differs significantly from the sanctity accorded an individual’s home, and that his privacy interest may, in certain circumstances, be adequately protected by regulatory schemes authorizing warrantless inspections.” Donovan, 452 U.S. at 598-99, 101 S.Ct. 2534. The Court has been vigilant at noting, however, that “ ‘except in [such] carefully defined classes of cases, a search of private property without proper consent is “unreasonable” unless it has been authorized by a valid search warrant.’ ” Barlow’s, 436 U.S. at 312, 98 S.Ct. 1816 (quoting Camara v. Municipal Court, 387 U.S. 523, 528-29, 87 S.Ct. 1727, 18 L.Ed.2d 930 (1967)). While the Supreme Court has never considered the exception, now referred to as the Colonnade-Biswelll exception, Burger, 482 U.S. at 701, 107 S.Ct. 2636, in the context of the FDCA, the United States Court of Appeals for the Eighth, Ninth, and Sixth Circuits have found the pharmaceutical industry to be so “pervasively regulated” that a warrantless search is permissible under the Fourth Amendment. See United States v. Jamieson-McKames Pharmaceuticals, Inc., 651 F.2d 532 (8th Cir.1981) (holding drug manufacturing industry closely regulated in review of administrative inspection warrant issued to the FDA under FDCA); accord United States v. Argent Chemical Laboratories, Inc., 93 F.3d 572 (9th Cir.1996) (finding pharmaceutical industry “closely regulated” in review of in rem warrant issued to FDA under 21 U.S.C. § 334); United States v. Acklen, 690 F.2d 70, 75 (6th Cir.1982) (in review of DEA search warrant under 21 U.S.C. § 880, held pharmaceutical industry is “closely regulated” industry in context of Colonnade-Biswelll exception). The Colonnade-Biswelll exception was qualified somewhat in Barlow’s. There, the Court reviewed the propriety of a war-rantless search without consent under section 8(a) of the Occupational Safety and Health Act of 1970, 29 U.S.C. § 657(a). As the Court interpreted it, section 8(a) “empowers agents of the Secretary of Labor ... to search the work area of any employment facility within the Act’s jurisdiction. The purpose of the search is to inspect for safety hazards and violations of OSHA regulations. No warrant or other process is expressly required under the Act.” Barlow’s, 436 U.S. at 309, 98 S.Ct. 1816. The Court discussed the decreased expectation of privacy in commercial property and the “continued vitality” of the Colonnade-Biswelll doctrine, “but declined to find that warrantless inspections, made pursuant to [OSHA], of all businesses engaged in interstate commerce fell within the narrow focus of this doctrine.” Burger, 482 U.S. at 701, 107 S.Ct. 2636 (discussing the holding and import of Barlow’s) (emphasis in original). While the Court’s greatest concern was that the OSHA statute was not limited to one industry, it also expressed concern that the statute did not mention the authorized frequency of inspections. Barlow’s, 436 U.S. at 316-17, 98 S.Ct. 1816. The Court emphasized that regulatory investigators operating under statutes failing the Colonnade-Biswelll exception are not without recourse. Reconfirming the process established in Camara v. Municipal Court, 387 U.S. 523, 528-29, 87 S.Ct. 1727, 18 L.Ed.2d 930 (1967), the Court directed that enforcement need not be curtailed as warrants may be obtained ex parte and executed without notice to the establishment being inspected. Barlow’s, 436 U.S. at 316-320, 98 S.Ct. 1816. Moreover, probable cause in the criminal law sense is not required to support the issuance of an administrative warrant. Barlow’s, 436 U.S. at 320, 98 S.Ct. 1816. See also U.S. v. Prendergast, 585 F.2d 69, 70 (3d Cir.1978) (citing Barlow’s). “For purposes of an administrative search such as this, probable cause justifying the issuance of a warrant may be based not only on specific evidence of an existing violation ... but also on a showing that ‘reasonable legislative or administrative standards for conducting an ... inspection are satisfied with respect to a particular [establishment].’” Id. at 320, 98 S.Ct. 1816 (quoting Camara, 387 U.S. at 538, 87 S.Ct. 1727) (footnote omitted). This lesser standard of probable cause derives from the general recognition that the expectation of privacy of an owner or operator of a business establishment is tempered by the public interest duly recognized by the established regulatory scheme. The warrant must still fulfill the traditional tasks of “providing] assurances from a neutral officer that the inspection is reasonable under the Constitution, is authorized by statute, and is pursuant to an administrative plan containing specific neutral criteria.” Barlow’s, 436 U.S. at 323, 98 S.Ct. 1816. As the Court explained in Camara: The warrant procedure is designed to guarantee that a decision to search private property is justified by a reasonable governmental interest. But reasonableness is still the ultimate standard. If a valid public interest justifies the intrusion contemplated, then there is probable cause to issue a suitably restricted search warrant. Such an approach neither endangers time-honored doctrines applicable to criminal investigations nor makes a nullity of the probable cause requirement in this area. It merely gives full recognition to the competing public and private interests here at stake and, in so doing, best fulfills the historic purpose behind the constitutional right to be free from unreasonable government invasions of privacy. Camara, 387 U.S. at 539, 87 S.Ct. 1727 (internal citations omitted). “To apply this standard, it is ... necessary first to focus upon the governmental interest which allegedly justifies official intrusion upon the constitutionally protected interests of the private citizen.” Camara, 387 U.S. at 534-535, 87 S.Ct. 1727. “In determining whether a particular inspection is reasonable—and thus in determining whether there is probable cause to issue a warrant for that inspection—the need for the inspection must be weighed in terms of the[ ] reasonable goals of code enforcement.” Id. at 535, 87 S.Ct. 1727. The relevant factors indicative of reasonableness include the government agency’s experience of the need for inspection to protect the public health or safety and the nature of the search as compared to the need fulfilled. Id. at 538, 87 S.Ct. 1727. Even passage of time without inspection alone can be sufficient to justify issuance of a warrant. Id. Once a court determines that the type of inspection is a “reasonable” search of private property within the meaning of the Fourth Amendment, a court must then consider whether “reasonable legislative or administrative standards for conducting [the particular inspection] are satisfied with respect to a particular dwelling.” Id. This should be an individualized review based upon the specific enforcement scheme. Id.; Barlow’s, 436 U.S. at 322-34, 98 S.Ct. 1816. Thus, the power to conduct an administrative inspection as well as the manner in which that inspection may be initiated derive from the language of the governing statute and any relevant regulations and procedures as determined by a neutral officer upon review of the warrant. Barlow’s, 320-21, 98 S.Ct. 1816; Showers v. Spangler, 182 F.3d 165, 173 (3d Cir.1999). Because the FDA obtained an administrative inspection warrant, this court need not reach the question of whether the FDCA governs a “pervasively regulated” industry under the Colonnade-Biswelll exception. The question only thus before this court is whether the warrant was valid under the above standard. B. The FDCA and the Statutory Authority to Inspect As noted above, the FDA relied upon 21 U.S.C. § 374(a)(1) as authority for the warrant. Subsection (a)(1) has three operative sentences. The first sentence, by its own terms, gives the FDA the authority to enter and inspect things: For purposes of enforcement of this chapter, officers or employees duly designated by the Secretary, upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge, are authorized (A) to enter, at reasonable times, any factory, warehouse, or establishment in which food, drugs, devices, or cosmetics are manufactured, processed, packed, or held, .for introduction into interstate commerce or after such introduction, or to enter any vehicle being used to transport or hold such food, drugs, devices, or cosmetics in interstate commerce; and (B) to inspect, at reasonable times and within reasonable limits and in a reasonable manner, such factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials, containers, and labeling therein. 21 U.S.C. § 374(a)(1) (emphasis supplied). The second sentence, as it is related to food adulteration, is not relevant to the instant matter. The third sentence gives the FDA the authority to enter and inspect records and documents and other information related to drugs for human use: In the case of any factory, warehouse, establishment, or consulting laboratory in which prescription drugs, nonprescription drugs intended for human use, or restricted devices are manufactured, processed, packed, or held, the inspection shall extend to all things therein (including records, files, papers, processes, controls, and facilities) bearing on whether prescription drugs, nonprescription drugs intended for human use, or restricted devices which are adulterated or misbranded within the meaning of this chapter, or which may not be manufactured, introduced into interstate commerce, or sold, or offered for sale by reason of any provision of this chapter, have been or are being manufactured, processed, packed, transported, or held in any such place, or otherwise bearing on violation of this chapter. 21 U.S.C. § 374(a)(1). All of these rights of inspection are granted “[f]or purposes of enforcement of this ehapter[.]” 21 U.S.C. § 374(a). The exemption for pharmacies immediately follows 374(a)(1), is found in 374(a)(2), and provides: (2) The provisions of the third sentence of paragraph (1) shall not apply to— (A) pharmacies which maintain establishments in conformance with any applicable local laws regulating the practice of pharmacy and medicine and which are regularly engaged in dispensing prescription drags or devices, upon prescriptions'of practitioners licensed to administer such drugs or devices to patients under the care of such practitioners in the course of their professional practice, and which do not, either through a subsidiary or otherwise, manufacture, prepare, propagate, compound, or process drugs or devices for sale other than in the regular course of their business of dispensing or selling drugs or devices at retail; ... 21 U.S.C. § 374(a)(2). By its own language, the exemption applies only to the third sentence. And by its own language, this exemption has three elements that must be met before a pharmacy may claim an exemption, i.e.: 1. maintain establishments in conformance with any applicable local laws regulating the practice of pharmacy and medicine and 2. which are regularly engaged in dispensing prescription drugs or devices, upon prescriptions of practitioners licensed to administer such drugs or devices to patients under the care of such practitioners in the course of their professional practice, and 3. which do not, either through a subsidiary or otherwise, manufacture, prepare, propagate, compound, or process drugs or devices for sale other than in the regular course of their business of dispensing or selling drugs or devices at retail. 21 U.S.C. § 374(a)(2) (emphasis supplied). Unless the pharmacy meets the elements of the exemption, the third sentence of Section 374 applies equally to pharmacies. Despite the clear language of the statute, Wedgewood argues that this exemption robs the FDA of any jurisdiction over pharmacies licensed by a state. Wedgewood’s argument, both on the papers and at oral argument before this court, is a lesson in obfuscation. Wedge-wood spends nearly half of its effort discussing the holding and dicta of Thompson v. Western States Medical Center, 535 U.S. 357, 122 S.Ct. 1497, 152 L.Ed.2d 563 (2002), a decision which invalidated under the First Amendment a portion of 21 U.S.C. § 353a, a section of the FDCA upon which the FDA did not rely in its application for a warrant before this court. Then it spends the balance of its argument discussing the FDA’s lack of jurisdiction under 21 U.S.C. § 374(a), the section upon which the FDA did rely in its application for a warrant. Yet, Wedgewood concedes that the FDA’s lack of jurisdiction relies upon Wedgewood’s representation that it meets the limited exemption for pharmacies contained in Section 374. It is this very representation that the FDA sought to confirm through the administrative inspection. Thus, Wedgewood’s argument relies solely on this court’s accepting on faith Wedgewood’s own representation that it meets a'statutory exemption that the FDA maintains it has breached. The fundamental problem with this argument is its naive insistence that a court should require the FDA to accept the representation of the very entity it is statutorily charged with policing. When confronted with this logical schism, Wedgewood suggested that the burden should be placed on the agency to prove, in a full declaratory judgment action, that the entity was not entitled to the statutory exemption. However, the interest of the public in the safety and efficacy of pharmaceutical remedies belies this procedure. Because Wedgewood so ardently and avidly opposes this conclusion, as well as the statutory and jurisprudential analysis that compels it, the court shall, in the interest of absolute clarity, review in detail Wedge-wood’s statutory argument. In its moving papers, Wedgewood asserts that the first sentence of § 374(a)(1) gives the FDA the right to “cross the threshold.” (Wedgewood Br. at 10). Wedgewood further maintains that the first sentence, including only “general language,” does not confer jurisdiction to anything other than enter the establishment: “The first sentence does not explain the purposes for which the agents may enter and what they may inspect for, which is not addressed until the third sentence of 374(a)(1).” (Id.). The argument continues that it is the third sentence which “explains that the purpose of the vestibule provision is to inspect ‘all things therein (including records, files, papers, processes, controls, and facilities, etc.’).” (Id.) (quoting 21 U.S.C. § 374(a)(1) (emphasis in brief)). Hence, Wedgewood concludes, if there is jurisdiction, they may inspect all things, and if there is no jurisdiction, they may inspect no things. (Id. at 11). Wedgewood then refers the court to the exemption contained in Section 374(a)(2) (noted supra), and argues that if the exemption applies, then there is no jurisdiction. (Id.). Finally, Wedgewood represents that it complies with the exemption section and is thus exempt from the third sentence, which, it maintains, is the only section that describes that which the FDA may inspect. (Id.). In its reply, Wedgewood presents the court with a different statutory analysis. (See Wedgewood Reply at 11-15). Wedge-wood refers the court to the FDCA’s registration provision, 21 U.S.C. § 360, as the “gateway” provision to Section 374. In the reply, Section 374 no longer confers any authority to enter, even in the general sense. Now Wedgewood argues, without reference to legislative history or supporting jurisprudence for its interpretation, that it is only the entities required to be registered under Section 360 whom the FDA is entitled to inspect under Section 374. Specifically, Wedgewood asserts that the FDA’s “right to inspect” is “granted” in Section 360(h). (Wedgewood Reply at 12). And the class of entities Congress intended to be registered is contained in Section 360(g). (Id.). Notably, Section 360(g)(1) contains the identical exclusion for pharmacies as appears in Section 374(a)(2). In this construct, Section 374 merely “deals with the form, nature and scope of the authorized inspections.” (Id.). Wedgewood concludes that “[s]ince pharmacies are not regulated under § 360(g)(1), they are not amenable to inspection under § 360(h) and, therefore, the scope and method of inspection set forth in § 374 is [sic] not germane.” (Id. at 13). Again, this entire argument misses the import of the actual question before the court, namely, who should and who does bear the initial burden to show whether or not the exemption applies to the pharmacy. That detail notwithstanding, neither of Wedgewood’s statutory analyses comports with the statutory language, legislative history, or relevant jurisprudence. As an initial matter of syntax, Wedge-wood’s construction of Section 374 is faulty. The first sentence specifically provides that “officers or employees duly designated by the Secretary ... are authorized (A) to enter ... and (B) to inspect!.]” 21 U.S.C. § 374(a)(1) (emphasis supplied). The places they may enter or inspect are “any factory, warehouse, or establishment in which food, drugs, devices, or cosmetics are manufactured, processed, packed, or held, for introduction into interstate commerce, or to. enter any vehicle being used to transport or hold such food, drugs, devices, or cosmetics in interstate commerce!.]” 21 U.S.C. § 374(a)(1)(A). This authorization applies so long as the inspection is conducted “[f]or purposes of enforcement of this chapter” and so long as those FDA officers present “appropriate credentials and a written notice” to a responsible person at the entity to be entered and inspected. Id. The first sentence contains additional instruction: the agents may not enter at any time, but “at reasonable times!.]” 21 U.S.C. § 374(a)(1)(A). Moreover, the first sentence places limits on the inspection permitted: it must be conducted “within reasonable limits and in a reasonable manner!.]” 21 U.S.C. § 374(a)(1)(B). Finally, the inspectors may not inspect just anything under the first sentence, but only “the factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials, containers, and labeling therein.” 21 U.S.C. § 374(a)(1)(B). The third sentence of Section 374(a)(1), added in 1962, relates to a different inspection right. In the case of “any factory, warehouse, establishment, or consulting laboratory in which prescription drugs, nonprescription drugs intended for human use, or restricted devices are manufactured, processed, packed, or held,” the third sentence extends the right of inspection to “all things therein (including records, files, papers, processes, controls, and facilities)” bearing on whether adulterated or misbranded or otherwise unlawful drugs or devices “have been or are being manufactured, processed, packed, transported, or held in any such place, or otherwise bearing on violation of this chapter.” 21 U.S.C. § 374(a)(1). It is to this sentence that the exemption contained in Section 374(a)(2) applies. And, as noted above, if the pharmacy meets the exemption, then it cannot be inspected under the third sentence. The court need not rely upon the language of the statute alone to come to this conclusion as to its meaning. The legislative history further clarifies Congress’s intent. The inspection section, 21 U.S.C. § 374, was promulgated with the inception of the FDCA in 1938. At the time, the first sentence of the section was very nearly identical to the current first sentence with one significant difference: it provided authority to enter and inspect “after first making request and obtaining permission of the owner, operator, or custodian” of the factory or other establishment. See Senate Report No. 712, 1953 U.S.Code Cong, and Adm. News., 2199. In 1938, the FDCA also included a section making it a violation of the Act to refuse entry or inspection to an FDA representative. See 21 U.S.C. § 331(f). Congress intended the statute to provide for inspections without prior notice with a violation for refusal of entry and inspection. See Senate Report No. 712, 1953 U.S.Code Cong, and Adm. News., 2199. In 1953, however, Congress amended the inspection section in response to the Supreme Court decision in U.S. v. Cardiff, 344 U.S. 174, 73 S.Ct. 189, 97 L.Ed. 200 (1952). Congress understood the holding of Cardiff to be that the then-provisions of the FDCA did “not clearly provide that the refusal to admit a food and drug inspector constitutes a violation of that act.” Senate Report No. 712, 1953 U.S.Code Cong, and Adm. News, 2199-2200. The Court based its decision on a clash in the language of Section 374, which referenced request and permission, with the language of section 331(f), which prohibited the refusal to permit entry or inspection under Section 374. Id. The Court held that the FDA could not sanction an entity for refusing to permit inspectors entry and inspection under the FDCA. Congress felt strongly enough about this right to enter and inspect and the concomitant violation upon refusal that it amended the statute less than one year after the Cardiff decision. The Senate report explained: “The situation resulting from the Supreme Court decision is that operators in the food, drug, and cosmetic industries will have an opportunity, through refusal to permit inspection, to disregard with impunity the sanitary and other safeguards in the Federal Food, Drug, and Cosmetic Act.” Id. The report further noted both the importance of the FDA’s authority to inspect, and inspect with refusal resulting in violation of the FDCA, and the authority being vested in the FDA through the 1953 amendment: The decision of the Supreme court denying that Congress had granted enforceable inspection power, which is indispensable to the effective enforcement of the act, has, therefore, seriously jeopardized the protective services rendered by the Food and Drug Administration. Until this case was decided, the act was interpreted and administered by the Food and Drug Administration, with the concurrence of the overwhelming majority of the responsible trade organizations and members of the food, drug, and cosmetic industries, as granting the Administration the right to insist that its inspectors be permitted to enter and inspect. * * * * * * It is evident to the committee that if the Food and Drug Administration were to be deprived of such authority and were empowered only to make such inspections as are voluntarily agreed to by the persons whose establishments are to be inspected, the Federal Food, Drug, and Cosmetic Act would become virtually meaningless.... Moreover, such authority would avoid unfair competition from the fringe and racketeer operators that would necessarily force down the present high levels of sanitation, product safety, and honesty and fair dealing. The inspection powers which were exercised by the Food and Drug Administration prior to the decision in the Cardiff case, and which are provided for by this legislation, are a necessary part of a regulatory scheme intended to protect the health and lives of the public. The inspections are normally a matter of routine checking, primarily as to sanitary and related conditions but also as to product integrity and safety for use, and are not necessarily based on any prior suspicion or determination that the law has been or is being violated.... This legislation does not propose that food and drug inspectors shall have the power of arrest, or the • power to use force in order to gain admission to a factory or otherwise carry out an intended inspection.... The bill authorizes entry and inspection but does not authorize the inspector to enter the establishment by force. The owner is on notice, however, that he must permit a reasonable inspection. If he refuses such an inspection he is in violation of the act. Id. at 2200-2201. This was the state of the inspection power before the third sentence was added to subsection (a) in 1962. In 1962, Congress believed that the FDCA needed additional strengthening. Hence, Congress added, inter alia, the third sentence of Section 374 as well as the registration section, 21 U.S.C. § 360. The Senate Report specifically noted that “[t]he purpose of the proposed legislation, as amended, is to strengthen and broaden existing laws in the drug field so as to bring about better, safer medicine and to establish a more effective system of enforcement of the drug laws.” Senate Report No. 1744, 1962 U.S.Code Cong, and Adm. News, 2884. Section 374 was “intended to strengthen the Food and Drug Administration’s authority to inspect factories in which prescription drugs are manufactured, and to inspect all things therein bearing on whether articles are adulterated or misbranded. Exempted from such inspection are financial data, sales data other than shipment records, pricing data, and personnel data.” Id. at 2885. As part of this amendment, Section 360 established a new procedure intended to simplify the FDA’s control over drugs entering the stream of commerce: Section 3 of the bill [21 U.S.C. § 360], as amended, would provide a system under which every establishment in which drugs are manufactured or processed would be registered with the Department of Health, Education, and Welfare. The purpose of this provision is to assist the Food and Drug Administration to identify and inspect all places where drugs are being made, and to take appropriate action (by criminal proceedings, injunction, or seizure) against those who fail to register.... % :{: sji % * The committee believes that drugs should not be on the market unless the Food and Drug Administration knows who is making them, and where they are being made, and is able to inspect the facilities in which they are being made. This will help stop illicit and substandard manufacturers who do not follow the methods or establish the controls called for by good manufacturing practice. The registration system established by section 3 [21 U.S.C. § 360] of the bill, as amended, is thus a facet of the additional inspection authority provided in section 4 [21 U.S.C. § 374] of this proposal and the provisions on quality manufacturing controls in section 5 of this proposal. Id. at 2888-89. Finally, Section 201(d) of Pub.L. 87-781 provided that: “Nothing in the amendments made by subsections (a) and (b) of this section [amending subsecs, (a) and (b) of Section 374] shall be construed to negate or derogate from any authority of the Secretary existing prior to the enactment of this Act. [Oct. 10, 1962].” As the legislative history is clear that the FDA had authority through Section 374(a)(1) to enter and inspect prior to 1962, there is no question that following the 1962 amendments that authority was reinforced, not abrogated as Wedgewood urges. As for Wedgewood’s Section 360 analysis, the language and the legislative history noted above make clear that that too is inaccurate. As the legislative history indicates, the registration requirement was added in 1962 as an additional method to control the drug manufacturing industry. Section 360(g), the exemption subsection relating to pharmacies in the registration section, is identical to the exemption contained in the inspection section. As a matter of pure textual analysis, if an entity had to be registered under Section 360 for the FDA to have any authority to inspect it under Section 374, then there would be no need for the identical exemption in Section 374. Rather, as the legislative history supports, the inspection of premises provision contained in subsection (h) is merely a subset of the inspection power. That is, it imposes additional requirements on those entities who must be registered: they must submit to inspection “at least once in the two-year period beginning with the date of registration of such establishment pursuant to this section and at least once in every successive two-year period thereafter.” 21 U.S.C. § 360(h). Registered entities were thus put on notice that they would be scheduled for semi-regular inspections. Conversely, Section 374 contains no particular schedule for inspections of entities. Rather, it is within the discretion of the FDA to identify those entities that require inspection “[f]or purposes of enforcement of [the FDCA].” 21 U.S.C. § 374(a)(1). Moreover, the class of entities to be inspected under Section 374— “any factory, warehouse, or establishment in which food, drugs, devices, or cosmetics are manufactured, processed, packed, or held, for introduction into interstate commerce or after such introduction, or to enter any vehicle being used to transport or hod such food, drugs, devices, or cosmetics in interstate commerce” — is broader than the class of entities subject to registration — “every person who owns or operates any establishment in any State engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs ...” This difference highlights the alternative needs that the sections fill: registration for those entities that produce drugs versus inspection for any entity engaged in the vertically integrated process of bringing drug products to consumers. Thus, based on the statutory language and the legislative history, the court rejects Wedgewood’s argument both that Section 374 does not confer authority to inspect and that Section 360 is the gateway to a Section 374 inspection. One final aspect of the FDCA bears comment here. The FDCA contains provisions with explicit exemptions for the new drug, misbranding, and adulteration provisions. See, e.g., 21 U.S.C. §§ 353(b), 355(i). Neither pharmacies nor compounded drugs are expressly exempted. See Professionals and Patients for Cus tomized Care v. Shalala, 56 F.3d 592, 593 n. 3 (5th Cir.1995). For example, section 355, establishing the “new drugs” requirements, specifically includes an exemption for “drugs intended solely for investiga-tional use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs.” 21 U.S.C. § 355(i). It contains no reference, direct or oblique, to pharmacies or compounded drugs. Section 353(b) recognizes an exemption from section 352, the mis-branding provision, for “[a]ny drug dispensed by filling or refilling a written or oral prescription of a practitioner licensed by law to administer such drug[.]” But that exemption does not apply to mis-branding by false or misleading labels, 21 U.S.C. § 352(a), imitating other drugs, 21 U.S.C. § 352(f)(2), offering a drug for sale under the name of another drug, 21 U.S.C, § 352(i)(3), or packaging of drugs, 21 U.S.C. §§ 352(g), (h), and (p). Thus, the principal provisions regarding new drugs, misbranding and adulteration relevant to pharmacies’ practice were applied to them. Under the statutory maxim expressio unis est exclusio alterius, the exemptions specifically provided for certain entities, see, e.g., 355(f), render general application of the FDCA to pharmacies persuasive. See Continental Cas. Co. v. U.S., 314 U.S. 527, 533, 62 S.Ct. 393, 86 L.Ed. 426 (1942). No exemption from the substantive provisions of the FDCA thus resurrects Wedgewood’s statutory analysis, and instead directly refutes that analysis. This analysis notwithstanding, Wedge-wood’s feeling that it has operated under lesser scrutiny by the FDA over the years is not without basis, as will be discussed in the next section; however, that feeling is insufficient to overcome the clear legislative intent and reasonable agency interpretation that the court shall address in more detail below. C. The FDA’s Interpretation of Authority to Inspect under the FDCA Wedgewood argues that Section 374 does not confer authority to inspect by the FDA’s own admission, and thus that the warrant was requested in bad faith and is therefore invalid. This argument relies upon the FDA’s statements regarding its authority to inspect pharmacies under the FDCA. In the seminal decision of Chevron U.S.A, Inc. v. Natural Resources Defense Council, 467 U.S. 837, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984), the Supreme Court addressed the principles of a court’s review of an agency’s construction of the statute which it administers. In Chevron, the court of appeals had rejected the agency’s definition of the relevant statutory term. In reversing the court of appeals’s decision, the Court opined that “[t]he basic legal error of the Court of Appeals was to adopt a static judicial definition of [a term in the statute] when it had decided that Congress itself had not commanded that definition.” Id. at 842, 104 S.Ct. 2778. The Court reconfirmed the appropriate deference to agency interpretations: We have long recognized that considerable weight should be accorded to an executive department’s construction of a statutory scheme it is entrusted to administer, and the principle of deference to administrative interpretations “has been consistently followed by this Court whenever decision as to the meaning or reach of a statute has involved reconciling conflicting policies, and a full understanding of the force of the statutory policy in the given situation has depended upon more than ordinary knowledge respecting the matters subjected to agency regulations.... If this choice represents a reasonable accommodation of conflicting policies that were committed to the agency’s care by the statute, we should not disturb it unless it appears from the statute or its legislative history that the accommodation is not one that Congress would have sanctioned.” Id. at 844-45, 104 S.Ct. 2778 (quoting United States v. Shimer, 367 U.S. 374, 382, 81 S.Ct. 1554, 6 L.Ed.2d 908 (1961)) (footnote and internal citations omitted). Hence, a reviewing court should consider the statutory language with fluidity giving deference to the administrative interpretation. The Court clarified further: When a court reviews an agency’s construction of the statute which it administers, it is confronted with two questions. First, always, is the question whether Congress has directly spoken to the precise question at issue. If the intent of Congress is clear, that is the end of the matter; for the court, as well as the agency, must give effect to the unambiguously expressed intent of Congress. If, however, the court determines Congress has not directly addressed the precise question at issue, the court does not simply impose its own construction on the statute, as would be necessary in the absence of an administrative interpretation. Rather, if the statute is silent or ambiguous with respect to the specific issue, the question for the court is whether the agency’s answer is based on a permissible construction of the statute. Chevron, 467 U.S. at 842-43, 104 S.Ct. 2778. Notwithstanding deference to agency interpretation, “[t]he judiciary is the final authority on issues of statutory construction and must reject administrative constructions which are contrary to clear congressional intent.” Id. at 843 n. 9, 104 S.Ct. 2778. As discussed above, the court finds both the statute and Congressional intent to be clear with respect to the FDA’s authority to inspect under Section 374. Thus, at least with respect to the inspection permitted under the first sentence of Section 374, the FDA had the authority to inspect Wedgewood. The statute does not address, however, the question before this court of how the FDA is to determine whether a pharmacy meets the exemption contained in Section 374(a)(2), and thus has authority to inspect a pharmacy under the third sentence of Section 374. Despite Section 374’s long presence in the statutory scheme, the FDA has never promulgated regulations for Section 374. The FDA, however, has issued statements detailing its interpretation of the scope of the inspection power with respect to pharmacies. This interpretation has been evolving over the past decade, and continues, as Wedgewood points out, to be in a “state of flux.” (See Statement of Jane Axelrad, Director FDA Center for Drug Evaluation and Research, Office of Regulatory Policy, as reported in The Pharmacists’ eLink, 4/7/03, attached as Ex. 1 to Wedgewood’s Reply). The FDA initially published its interpretation of its authority under the FDCA with respect to pharmacies as Compliance Policy Guide 7132.16 (“CPG 7132.16”) in 1992. Prior to this, the FDA “generally left regulation of compounding to the States.” Western States, 535 U.S. at 362, 122 S.Ct. 1497. And, indeed, many States “specifically regulate compounding practices as part of their regulation of pharmacies.” Id. at 361, 122 S.Ct. 1497. Compounding, all parties agree, is a traditional practice of pharmacies. It is the “process by which a pharmacist or doctor combines, mixes, or alters ingredients to create a medication tailored to the needs of an individual patient.” Id. at 360-61, 122 S.Ct. 1497. Pharmacists compound to provide medications either that are not commercially available or are in forms that are not commercially available: diluted doses for children, lozenges rather than pills, omission of an ingredient to account for a patient’s allergies. Id. at 361, 122 S.Ct. 1497; Shalala, 56 F.3d at 593. As the Shalala court explained, “[b]y the 1990’s, the FDA had become aware that many establishments with retail pharmacy licenses were purchasing large quantities of bulk drug substances; combining those substances into specific drug products before ever receiving any valid prescriptions; and then marketing those drug products to practitioners and patients.” 56 F.3d at 593. CPG 7132.16 addressed the growing concern by the FDA that these practices evidenced pharmacy manufacturing drugs under the guise of compounding to avoid the requirements of the FDCA. See Shalala, 56 F.3d at 593; see also Western States, 535 U.S. at 362, 122 S.Ct. 1497. The FDA announced the following policy in the CPG: FDA recognizes that a licensed pharmacist may compound drugs extemporaneously after receipt of a valid prescription for an individual patient.... Pharmacies that do not otherwise engage in practices that extend beyond the limits set forth in this CPG may prepare drugs in very limited quantities before receiving a valid prescription, provided they can document a history of receiving valid prescriptions that have been generated solely within an established professional practitioner-patient-pharmacy relationship and provided further that they maintain the prescription on file for all such products dispensed at the pharmacy as required by state law. If a pharmacy compounds finished drugs from bulk active ingredient materials considered to be unapproved new drug substances, as defined in 21 CFR 310.3(g), such activity must be covered by an FDA-sanctioned investigational new drug application (IND) that is in effect in accordance with 21 U.S.C. Section 355(i) and 21 CFR 312. Pharmacies may not, without losing their status as retail entities, compound, provide, and dispense drugs to third parties for resale to individual patients. FDA will generally continue to defer to state and local officials (sic) regulation of the day-to-day practice of retail pharmacy and related activities.... FDA may, in the exercise of its enforcement discretion, initiate federal enforcement actions against entities and responsible persons when the scope and nature of a pharmacy’s activity raises the kind of concerns normally associated with a manufacturer and that results in significant violations of the new drug, adulteration, or misbranding provisions of the Act. CPG 7132.16 (quoted in Shalala, 56 F.3d at 593-94). The policy statement was followed by nine factors the FDA would consider when determining whether to begin an enforcement action against a pharmacy. See id. As a CPG, this policy was not binding on pharmacies, but rather constituted an advisory opinion. Id. t 596. FDA regulations indicate that advisory opinions “may be used in administrative or court proceedings to illustrate acceptable and unacceptable procedures or standards, but not as a legal requirement.” 21 C.F.R. § 10.85(3); see also Shalala, 56 F.3d at 596. In 1997, Congress, recognizing the gap that this CPG filled in the FDCA, turned portions of this CPG into law when it enacted the Food and Drug Administration Modernization Act, 21 U.S.C. § 353a. The FDAMA specifically exempted pharmacy compounding from section 351(a)(2)(B) regarding adulterated drugs and good manufacturing practices, section 352(f)(1) regarding labeling, and section 355 regarding new drugs. Notably, even the exemption contained in the FDAMA did not exempt pharmacies from every relevant provision in the FDCA. Nevertheless, the “new drug” exemption for traditional pharmaceutical compounding practices represents a significant exemption. Before the FDAMA took effect, a coalition of licensed pharmacies challenged the constitutionality of one of the provisions in the new act — that precluding solicitation through advertising and promotion of pharmaceutical compounds by pharmacies — as an unconstitutional restriction on commercial speech. See Western States, 535 U.S. at 365, 122 S.Ct. 1497; see also CPG 460.200. In February 2001, the United States Court of Appeals for the Ninth Circuit held that the speech restrictions included as conditions for the exemption in section 353a violated the First Amendment and further held that the speech restrictions not severable from the whole, thus ruling section 353a unconstitutional in its entirety. Western States Medical Center v. Shalala, 238 F.3d 1090 (9th Cir.2001). The parties appealed to the Supreme Court which granted certiorari “to consider whether the FDAMA’s prohibitions on soliciting prescriptions for, and advertising, compounded drugs violate the First Amendment.” Western States, 535 U.S. at 366, 122 S.Ct. 1497. The Court specifically noted that “[b]ecause neither party petitioned for certiorari on the severability issue, we have no occasion to review that portion of the Court of Appeals’ decision.” Id. Thus, the Ninth Circuit decision with respect to severability remains, and neither Wedgewood nor the FDA looks to section 353a as a viable basis for decision making. The Court’s Western States decision, issued on April 29, 2002, sent the FDA back to the proverbial drafting room to develop a revised CPG governing compounding and pharmacies. In May 2002, the FDA issued a new CPG, CPG 460.200, and explained its purpose in the following way: This document provides guidance to drug compounders and the staff of the Food and Drug Administration (FDA) on how the Agency intends to address pharmacy compounding of human drugs in the imme